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DAPAGLIFLOZIN PROPANEDIOL

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What DAPAGLIFLOZIN PROPANEDIOL does in the body

The drug blocks the transporter your kidney uses to reclaim sugar from the fluid it has just filtered.

Around 70 grams of glucose a day leaves in the urine, and sodium and water go with it. The load on the heart falls, the pressure inside each kidney filter falls, and over years fewer people are admitted with heart failure and fewer kidneys fail. The blood sugar effect is real, modest, and not the reason most people are now given it.

Why people take it. Heart failure, chronic kidney disease, and type 2 diabetes with heart or kidney risk

What happened in people

Worsening heart failure or cardiovascular death 16.3% against 21.2% in 4,744 patients with reduced ejection fraction, with all-cause death 11.6% against 13.9%

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That SGLT2 inhibition prevents heart attacks and strokes — DECLARE-TIMI 58 tested exactly that and gave p=0.17

Where it acts
Brush border of the renal proximal convoluted tubule, segment S1 and S2
Kind of result
Living longer, or avoiding a major event
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • Its recorded molecular formula is C21H25ClO6, weighing 408.88.

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 121 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved9 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Body weightNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
CholesterolNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
hba1c compared to placebo; adjusted mean change in hba1c levels; urinary glucose excretion dynamics; adjusted mean change from baseline in hba1c levels; insulin sensitivity; 7 glucose monitoring at day 7; adjusted mean change in hba1c from baseline to week 24; glucose levels at minute 0 at week 12
Body weight
adjusted mean change in total body weight
Cholesterol
triglycerides levels at week 12

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
9 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Results from the one trial this record names

  • In NCT03036124, Subjects included in the composite endpoint of CV death, hospitalization due to heart failure or urgent visit due to heart failure (primary efficacy) was 386 participants (dapagliflozin 10 mg arm) against 502 participants (placebo arm) in the comparison group at Up to 27.8 months. The recorded difference is Hazard Ratio (HR) 0.74 (95% CI 0.65 to 0.85; p<0.0001).

    ClinicalTrials.gov record · NCT03036124 · read 2026-08-27

Co-primary efficacy: major adverse cardiovascular events, and cardiovascular death or hospitalisation for heart failure

The study did not show it

Who was studied
DECLARE-TIMI 58 (NCT01730534)
How many people
17160
Study design
Randomised double-blind placebo-controlled trial, median 4.2 years
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
MACE HR 0.93 (95% CI 0.84-1.03), P = 0.17 — missed; the heart failure composite met at HR 0.83, P = 0.005
Repeated elsewhere
Partially Replicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Diabetic ketoacidosis 0.3% against 0.1% (p=0.02); serious or discontinuation-causing genital infection 0.9% against 0.1% (p<0.001). All-cause death 6.2% against 6.6%, not significant.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and fixed combinations with metformin and with saxagliptin

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Worsening heart failure or cardiovascular death, ejection fraction ≤40%

The study showed what it set out to show

Who was studied
DAPA-HF (NCT03036124)
How many people
4744
Study design
Randomised double-blind placebo-controlled phase 3 trial, median 18.2 months
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
HR 0.74 (95% CI 0.65-0.85), P < 0.001
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and fixed combinations with metformin and with saxagliptin

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Sustained eGFR decline of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes

The study showed what it set out to show

Who was studied
DAPA-CKD (NCT03036150)
How many people
4304
Study design
Randomised double-blind placebo-controlled trial, stopped early for efficacy, median 2.4 years
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
HR 0.61 (95% CI 0.51-0.72), P < 0.001; number needed to treat 19
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Stopping early for efficacy inflates measured effect sizes and truncates long-term safety observation.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and fixed combinations with metformin and with saxagliptin

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Worsening heart failure or cardiovascular death, ejection fraction above 40%

The study showed what it set out to show

Who was studied
DELIVER (NCT03619213)
How many people
6263
Study design
Randomised double-blind placebo-controlled trial, median 2.3 years
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
HR 0.82 (95% CI 0.73-0.92), P < 0.001
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Cardiovascular death alone gave HR 0.88 (0.74-1.05), an interval including no effect. The composite was carried by worsening heart failure.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and fixed combinations with metformin and with saxagliptin

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Hierarchical composite of death, heart failure hospitalisation, non-fatal infarction, atrial fibrillation, new type 2 diabetes, NYHA class and 5% body-weight decrease, by win ratio

The study showed what it set out to show

Who was studied
DAPA-MI (NCT04564742)
How many people
4017
Study design
Registry-based randomised double-blind trial, approximately 1 year
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Win ratio 1.34 (95% CI 1.20-1.50), P < 0.001
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. The win-ratio endpoint was adopted in a change of analysis during the trial because of low event accrual, and the result was driven mainly by the added cardiometabolic components. Cardiovascular death or heart failure hospitalisation was 2.5% against 2.6%, HR 0.95.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and fixed combinations with metformin and with saxagliptin

Interval reported. 95% CI 1

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.21 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

Where a source records it acting

  • Kidneys: Inhibits SGLT2 in the proximal renal tubules, reducing reabsorption of filtered glucose (as recorded)

    US prescribing information · 01f90c94-71cb-4a1f-81ff-8004b850529b · read 2026-08-27

  1. Start

    DAPAGLIFLOZIN PROPANEDIOL

    What a person takes: Oral tablet, and fixed combinations with metformin and with saxagliptin.

    The measurement behind this step

    Once daily, with or without food. Cleared by glucuronidation rather than by cytochrome P450, giving a short interaction list. Its glucose-lowering effect depends on filtered glucose load and diminishes as kidney function falls, while its heart failure and renal benefits were demonstrated down to an eGFR of 25.

  2. Getting in

    Absorbed rapidly, cleared by glucuronidation rather than by cytochromes

    The tablet is well absorbed and the body disposes of it by attaching a sugar-derived tag, not by the liver enzyme system that most drug interactions run through.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Oral bioavailability is about 78%, with peak plasma concentration within two hours and a terminal half-life of roughly 12.9 hours. Clearance is dominated by UGT1A9-mediated glucuronidation to the inactive dapagliflozin 3-O-glucuronide, with minimal cytochrome P450 involvement — which is why the interaction list is short.

  3. Reaching the cell

    Filtered and secreted into the tubule to reach its target from the urine side

    The transporter it blocks faces the fluid that has just been filtered out of the blood, so the drug has to get into that fluid to work.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    SGLT2 is expressed on the apical brush border of proximal tubule segments S1 and S2, where it reabsorbs roughly 90% of filtered glucose. Access is luminal. SGLT1, in segment S3 and throughout the small intestine, reclaims the remainder, which is why maximal SGLT2 inhibition still leaves some glucose reabsorption intact.

  4. What it acts on

    A glucose mimic that cannot be cut apart occupies the transporter

    The drug carries a sugar ring joined to the rest of the molecule by a bond the body cannot break, so it sits in the transporter instead of being digested out of it.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Dapagliflozin is a C-aryl glucoside: the carbon-carbon glycosidic linkage resists beta-glucosidase hydrolysis, the flaw that made phlorizin undevelopable. Selectivity for SGLT2 over SGLT1 is roughly 1,200-fold, sufficient to leave intestinal glucose absorption unaffected.

  5. The change it makes

    Glucose, sodium and water leave together, and the kidney filter resets its pressure

    Unreclaimed sugar drags water out with it and leaves sodium behind in the tubule. A sensor further along reads that extra sodium and tightens the vessel feeding the filter, lowering the pressure across it.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Urinary glucose excretion rises to roughly 70 grams daily with accompanying osmotic diuresis and natriuresis. Increased sodium chloride delivery to the macula densa restores tubuloglomerular feedback, constricting the afferent arteriole and reducing intraglomerular hypertension — the leading explanation for the initial eGFR dip and for the long-term slowing of decline.

  6. What that does for a person

    Heart failure events and kidney decline fall; heart attacks do not

    Across four large trials the consistent findings are fewer heart failure admissions and slower kidney deterioration. Heart attacks and strokes were not reduced.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    In DECLARE-TIMI 58 the MACE hazard ratio was 0.93 (p=0.17) while heart failure hospitalisation fell to 0.73 and the renal composite to 0.76. In DAPA-CKD the primary composite hazard ratio was 0.61 with a number needed to treat of 19, and all-cause mortality 0.69. In DAPA-HF all-cause mortality was 0.83.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • hba1c compared to placebo
  • blood and urine pk samples
  • iohexol pk blood urine samples for gfr assessment
  • adjusted mean change in hba1c levels
  • urinary glucose excretion dynamics
  • adjusted mean change in total body weight
  • adjusted mean change from baseline in hemoglobin at week 12
  • glycosylated haemoglobin a1c
  • serum uric acid
  • seated heart rate

and 11 more.

Meaningful

Things that change how a life goes, not only a number.

No registered study measured anything of this kind.

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (19)
  • aes vital signs physical exam
  • ecgs
  • clinical labs
  • urine safety markers
  • electronic measures of heart beats
  • oral bioavailability
  • calculation of derivation of pharmacokinetic variables
  • adverse events
  • serious adverse events
  • at least one episode of hypoglycemia
  • hematocrit
  • alanine aminotransferase
  • aspartate aminotransferase
  • blood urea nitrogen
  • magnesium
  • high density lipoprotein levels at week 12
  • insulinogenic index at week 12
  • stumvoll index at week 12
  • matsuda index at week 12

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • People with heart failure across the ejection fraction range, people with chronic kidney disease at risk of progression, and people with type 2 diabetes and cardiovascular risk. On the WHO Model List of Essential Medicines.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

Who a named study recorded including and excluding

  • It included: Male or female, aged ≥18 years; Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months; LVEF≤40%; Elevated NT-proBNP levels; eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1).

    ClinicalTrials.gov record · NCT03036124 · read 2026-08-27

  • It excluded: Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor; Type 1 diabetes mellitus; Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2; Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment; MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment; Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization.

    ClinicalTrials.gov record · NCT03036124 · read 2026-08-27

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of dapagliflozin for glycemic control in type 2 diabetes mellitus have not been established in pediatric patients less than 10 years of age.”

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-30

  • On older people, the label states: “No dapagliflozin dosage change is recommended based on age.”

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on animal data showing adverse renal effects, dapagliflozin tablets are not recommended during the second and third trimesters of pregnancy.”

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is recommended for patients with mild, moderate, or severe hepatic impairment.”

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Dapagliflozin tablets was evaluated in two glycemic control adult trials that included patients with type 2 diabetes mellitus with moderate renal impairment (an eGFR of 45 to less than 60 mL/min/1.73 m 2 [see Clinical Studies ( 14.1 )] , and an eGFR of 30 to less than 60 mL/min/1.73 m 2 , respectively) .”

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-30

Where the result stopped carrying

  • DECLARE-TIMI 58 missed the major adverse cardiovascular event co-primary endpoint in 17,160 patients
  • DAPA-MI could not accumulate enough hard events to test its original endpoint and switched analysis method mid-trial
  • Cardiovascular death alone was not significantly reduced in DECLARE-TIMI 58 or in DELIVER
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (9)
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral tablet, and fixed combinations with metformin and with saxagliptin

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Once daily, with or without food. Cleared by glucuronidation rather than by cytochrome P450, giving a short interaction list. Its glucose-lowering effect depends on filtered glucose load and diminishes as kidney function falls, while its heart failure and renal benefits were demonstrated down to an eGFR of 25.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Genital mycotic infection is the commonest adverse effect and the commonest reason for discontinuation. Diabetic ketoacidosis occurred in 0.3% against 0.1% on placebo in DECLARE-TIMI 58 and can present with normal blood glucose. Fournier gangrene is a rare labelled warning. Volume depletion and hypotension occur, particularly alongside loop diuretics. An expected initial dip in eGFR occurs on starting and reflects the intended haemodynamic change rather than injury.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

DAPAGLIFLOZIN PROPANEDIOL appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3848 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • diabetic ketoacidosis — 1452 reaction mentions
  • ketoacidosis — 456 reaction mentions
  • euglycaemic diabetic ketoacidosis — 284 reaction mentions
  • acute kidney injury — 275 reaction mentions
  • weight decreased — 272 reaction mentions
  • urinary tract infection — 262 reaction mentions
  • dehydration — 241 reaction mentions
  • fungal infection — 237 reaction mentions
  • blood glucose increased — 204 reaction mentions
  • metabolic acidosis — 165 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral tablet, and fixed combinations with metformin and with saxagliptin

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Cleared by glucuronidation rather than by cytochrome P450, giving a short interaction list. Its glucose-lowering effect depends on filtered glucose load and diminishes as kidney function falls, while its heart failure and renal benefits were demonstrated down to an eGFR of 25.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 80 products list this as an active ingredient in the United States drug directory. 53 of them contain it and nothing else.

    FDA National Drug Code directory · 72205-435 · read 2026-08-29

  • They are sold as liquid, powder, tablet, tablet, extended release, tablet, film coated and tablet, film coated, extended release, taken oral.

    FDA National Drug Code directory · 72205-435 · read 2026-08-29

  • The regulator's established pharmacologic class for it is sodium-glucose cotransporter 2 inhibitor [epc] and sodium-glucose transporter 2 inhibitors [moa].

    FDA National Drug Code directory · 72205-435 · read 2026-08-29

  • 35 published labels name it as an active ingredient. 27 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 08baca21-e39e-4e61-961f-d89432fe8007 · read 2026-08-29

  • FARXIGA is film-coated tablets at Tablets: 5 mg and 10 mg, recorded as prescription product; fda label in effect 2026-07-10 in the United States.

    US prescribing information · 01f90c94-71cb-4a1f-81ff-8004b850529b · read 2026-08-27

  • Recorded price in US: 0.18453–0.20494 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 40 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

Names and forms linked to this record

  • Contains

    Dapagliflozin

    Evidence on this page does not automatically apply to this one.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of DAPAGLIFLOZIN PROPANEDIOL studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That SGLT2 inhibition prevents heart attacks and strokes — DECLARE-TIMI 58 tested exactly that and gave p=0.17

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That dapagliflozin improves outcomes after myocardial infarction — DAPA-MI won on a mid-trial redefined composite driven by weight and new diabetes diagnoses, while cardiovascular death and heart failure hospitalisation were 2.5% against 2.6%

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the drug reduces mortality generally — it did in DAPA-HF and DAPA-CKD, and did not in DECLARE-TIMI 58 or on cardiovascular death in DELIVER

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That dapagliflozin and empagliflozin are interchangeable on outcomes — no head-to-head trial has been run

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of DAPAGLIFLOZIN PROPANEDIOL are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

DECLARE-TIMI 58: the atherosclerotic endpoint missed and the heart failure one hit
In plain words
In more than seventeen thousand people with type 2 diabetes, the drug did not reduce heart attacks, strokes or cardiovascular deaths. It did reduce hospitalisation for heart failure, and it slowed kidney decline.
What was measured
Major adverse cardiovascular events and the composite of cardiovascular death or heart failure hospitalisation over a median 4.2 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
DECLARE-TIMI 58 evaluated 17,160 patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, including 10,186 without established atherosclerotic disease, over a median 4.2 years. Dapagliflozin met the prespecified non-inferiority criterion for the major adverse cardiovascular event safety outcome. On the two primary efficacy analyses, it did not reduce MACE (8.8% against 9.4%; hazard ratio 0.93, 95% CI 0.84 to 1.03, p=0.17) but did reduce cardiovascular death or hospitalisation for heart failure (4.9% against 5.8%; hazard ratio 0.83, 0.73 to 0.95, p=0.005). That composite reflected hospitalisation for heart failure (hazard ratio 0.73, 0.61 to 0.88); cardiovascular death alone showed no difference (0.98, 0.82 to 1.17). A renal event occurred in 4.3% against 5.6% (0.76, 0.67 to 0.87). Death from any cause was 6.2% against 6.6% (0.93, 0.82 to 1.04) — not a demonstrated difference.
Source
Wiviott SD et al., DECLARE-TIMI 58, N Engl J Med 2019;380:347-357 (NCT01730534)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
DAPA-HF: fewer deaths in heart failure, with or without diabetes
In plain words
Nearly five thousand people with a weakened heart, over half of them without diabetes, were randomised. Worsening heart failure and cardiovascular death fell by a quarter, and deaths from any cause fell too.
What was measured
Worsening heart failure or cardiovascular death, and death from any cause, over a median 18.2 months
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
DAPA-HF randomised 4,744 patients with NYHA class II-IV heart failure and ejection fraction of 40% or less to dapagliflozin 10 mg daily or placebo on top of recommended therapy. Over a median 18.2 months the primary composite of worsening heart failure — hospitalisation or an urgent visit requiring intravenous therapy — or cardiovascular death occurred in 386 of 2,373 (16.3%) against 502 of 2,371 (21.2%): hazard ratio 0.74 (95% CI 0.65 to 0.85), p<0.001. First worsening heart failure event 10.0% against 13.7% (0.70, 0.59 to 0.83). Cardiovascular death 9.6% against 11.5% (0.82, 0.69 to 0.98). Death from any cause 11.6% against 13.9% (0.83, 0.71 to 0.97). Findings in patients with diabetes were similar to those without. Adverse events relating to volume depletion, renal dysfunction and hypoglycaemia did not differ between groups.
Source
McMurray JJV et al., DAPA-HF, N Engl J Med 2019;381:1995-2008 (NCT03036124)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
DAPA-CKD: stopped early for efficacy, with a number needed to treat of 19
In plain words
A trial in chronic kidney disease was halted early by its monitoring committee because the benefit was so clear. Nineteen people needed treating over about two and a half years to prevent one kidney or cardiovascular event.
What was measured
Sustained 50% eGFR decline, end-stage kidney disease, or renal or cardiovascular death, and all-cause mortality, over a median 2.4 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
DAPA-CKD randomised 4,304 participants with eGFR 25 to 75 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio 200 to 5,000 mg/g to dapagliflozin 10 mg daily or placebo. The independent data monitoring committee recommended stopping for efficacy. Over a median 2.4 years the primary composite of sustained eGFR decline of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes occurred in 197 of 2,152 (9.2%) against 312 of 2,152 (14.5%): hazard ratio 0.61 (95% CI 0.51 to 0.72), p<0.001, number needed to treat 19 (15 to 27). The pure kidney composite gave 0.56 (0.45 to 0.68, p<0.001) and the cardiovascular death or heart failure hospitalisation composite 0.71 (0.55 to 0.92, p=0.009). Death from any cause occurred in 101 (4.7%) against 146 (6.8%): hazard ratio 0.69 (0.53 to 0.88), p=0.004. Effects were similar with and without type 2 diabetes.
Source
Heerspink HJL et al., DAPA-CKD, N Engl J Med 2020;383:1436-1446 (NCT03036150)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
DELIVER: benefit above an ejection fraction of 40%, without a mortality difference
In plain words
In six thousand people with heart failure and a normal or near-normal pumping fraction, the combined endpoint fell. Cardiovascular deaths alone did not significantly differ.
What was measured
Worsening heart failure or cardiovascular death over a median 2.3 years, ejection fraction above 40%
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
DELIVER randomised 6,263 patients with heart failure and left ventricular ejection fraction above 40% to dapagliflozin 10 mg daily or matching placebo on top of usual therapy. Over a median 2.3 years the primary composite of worsening heart failure — unplanned hospitalisation or an urgent visit — or cardiovascular death occurred in 512 of 3,131 (16.4%) against 610 of 3,132 (19.5%): hazard ratio 0.82 (95% CI 0.73 to 0.92), p<0.001. Worsening heart failure occurred in 11.8% against 14.5% (0.79, 0.69 to 0.91). Cardiovascular death occurred in 7.4% against 8.3%: hazard ratio 0.88 (0.74 to 1.05) — an interval that includes no effect. Results were similar in those with ejection fraction of 60% or more and below 60%, and in those with and without diabetes. Adverse event incidence was similar between groups.
Source
Solomon SD et al., DELIVER, N Engl J Med 2022;387:1089-1098 (NCT03619213)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
DAPA-MI changed its primary endpoint mid-trial, and the change decided the result
In plain words
A trial after heart attack could not accumulate enough hard events, so during the trial the analysis was switched to a scoring method that also counts weight loss and new diabetes diagnoses. On that measure it won; on death and heart failure hospitalisation it did not move.
What was measured
Hierarchical win-ratio composite, and separately the composite of cardiovascular death or heart failure hospitalisation
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
DAPA-MI was a registry-based randomised double-blind trial in patients without prior diabetes or chronic heart failure presenting with acute myocardial infarction and impaired left ventricular systolic function; 2,019 received dapagliflozin and 1,998 placebo. The primary outcome was a hierarchical composite analysed by win ratio comprising death, heart failure hospitalisation, non-fatal infarction, atrial fibrillation or flutter, new type 2 diabetes, NYHA class at last visit and a body-weight decrease of 5% or more. The win ratio was 1.34 (95% CI 1.20 to 1.50), p<0.001. The paper states directly that this outcome was adopted in a change of analysis during trial performance because of low event accrual, and that the result was mainly driven by the added cardiometabolic outcomes. The conventional composite of cardiovascular death or heart failure hospitalisation occurred in 50 of 2,019 (2.5%) against 52 of 1,998 (2.6%): hazard ratio 0.95 (0.64 to 1.40). Other cardiovascular event differences did not reach nominal significance.
Source
James S et al., DAPA-MI, NEJM Evid 2024;3(2) (NCT04564742)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The harms are small, specific and randomised
In plain words
Across seventeen thousand patients the two things that happened more often on dapagliflozin were ketoacidosis and genital infections severe enough to stop the drug. Both were uncommon and both were clearly attributable.
What was measured
Rates of diabetic ketoacidosis and of serious or discontinuation-causing genital infection in 17,160 randomised patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In DECLARE-TIMI 58, diabetic ketoacidosis occurred in 0.3% on dapagliflozin against 0.1% on placebo (p=0.02), and genital infections that led to discontinuation of the regimen or were considered serious adverse events occurred in 0.9% against 0.1% (p<0.001). In DAPA-HF, adverse events relating to volume depletion, renal dysfunction and hypoglycaemia did not differ between groups, and in DELIVER overall adverse event incidence was similar. The pattern across trials is consistent: the class carries two mechanism-specific risks of low absolute frequency, and does not carry the general tolerability burden that its diuretic and renin-angiotensin comparators do.
Source
Wiviott SD et al., N Engl J Med 2019;380:347-357; McMurray JJV et al., N Engl J Med 2019;381:1995-2008
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
A mortality benefit exists in two trials and not in the other two
In plain words
The class is often described as reducing deaths. For this drug, deaths fell significantly in the heart failure trial and the kidney trial, and did not in the diabetes trial or the preserved-ejection-fraction trial.
What was measured
That dapagliflozin reduces all-cause mortality generally — it did so in heart failure with reduced ejection fraction and in chronic kidney disease, and not in the other two large trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
All-cause mortality by trial: DAPA-HF 11.6% against 13.9%, hazard ratio 0.83 (95% CI 0.71 to 0.97) — significant. DAPA-CKD 4.7% against 6.8%, hazard ratio 0.69 (0.53 to 0.88), p=0.004 — significant. DECLARE-TIMI 58 6.2% against 6.6%, hazard ratio 0.93 (0.82 to 1.04) — not significant. DELIVER did not show a significant difference in cardiovascular death (hazard ratio 0.88, 0.74 to 1.05). The populations differ in baseline risk and follow-up duration, which is a sufficient explanation and not a demonstrated one. A summary that says "dapagliflozin reduces mortality" without naming the population is reporting two trials and omitting two.
Source
McMurray JJV et al., N Engl J Med 2019;381:1995-2008; Heerspink HJL et al., N Engl J Med 2020;383:1436-1446; Wiviott SD et al., N Engl J Med 2019;380:347-357; Solomon SD et al., N Engl J Med 2022;387:1089-1098
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 26 documents were read for this substance.

    RNAWiki source record

  • 26 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 26 of them state the same tMax, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
887K2391VH
CAS registry number
461432-26-8
PubChem compound
9887712
RxNorm concept
1488564

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 37 approved applications cover products containing this substance. The earliest was NDA202293, approved 20140108 to ASTRAZENECA AB.

    Drugs@FDA application register · NDA202293 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA202293 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20140108.

    FDA National Drug Code directory · 72205-435 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

4 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

An SGLT2 inhibitor that missed the major-adverse-cardiovascular-event endpoint in 17,160 patients with type 2 diabetes (8.8% against 9.4%, p=0.17) and then reduced all-cause death in 4,744 heart failure patients and 4,304 chronic kidney disease patients, most of the latter without diabetes at all — a pattern that says the drug is not an anti-atherosclerotic and is something else.

Recorded evidence blocks (12)

What did DAPAGLIFLOZIN PROPANEDIOL's largest trial (781430 people) and its longest (13 years) measure?


781430 people in DAPAGLIFLOZIN PROPANEDIOL's largest registered study, 13 years in its longest registered window, measuring Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF). ClinicalTrials.gov · 2026-09-01

108 phase4, 96 phase3, 59 phase2, 42 phase1, 17 na or unstated, 11 na, 3 early phase1; NCT02969798; 2027-07. Last human test completed 2026, NCT06405178.

Interpretation These counts include studies where DAPAGLIFLOZIN PROPANEDIOL was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase4
    108
  • phase3
    96
  • phase2
    59
  • phase1
    42
  • na or unstated
    17
  • na
    11
2 more recorded rows
  • early phase1
    3
  • Last recorded human test NCT06405178
    2026-04-01

recorded 2026-09-01 · last checked 2026-09-04

DAPAGLIFLOZIN PROPANEDIOL was tested only in human — what did it show?


human: lifespan (323): the rungs where DAPAGLIFLOZIN PROPANEDIOL has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF) — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human lifespan
Show the evidence
  • human NCT03249506
    lifespan; Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF); 323

recorded 2026-09-01 · last checked 2026-09-04

23 of DAPAGLIFLOZIN PROPANEDIOL's trials stopped: safety, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (1), accrual/recruitment (10), funding/business (6), sponsor decision unspecified (1) and other (5): DAPAGLIFLOZIN PROPANEDIOL's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"FSI delayed until 15 January 2013"; 23 of 323 registered studies

Show the evidence

Trial

  • NCT01257412
    suspended; "FSI delayed until 15 January 2013"
  • NCT01944618
    terminated; "Participant Data obtained to 30Sep2015: Baseline data: 447 6 month data: 253 Program terminated: recruitment target not met. No analysis will be provided."
  • NCT02520518
    terminated; "Designed a new modified/simplified protocol see NCT 03180489"
  • NCT02608905
    terminated; "Due to difficulty with enrollment of subjects"
  • NCT02811484
    withdrawn; "Inability to enroll due to the widespread use of both classes of drugs in patients with T2DM, including those on concomitant insulin therapy."
  • NCT02887677
    terminated; "On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study."
14 further recorded trials
  • NCT03152084
    terminated; "Poor recruitment."
  • NCT03344341
    terminated; "Study overall progress behind of scheduled timeline. Study was terminated early due to company decision."
  • NCT03419624
    terminated; "Delay in patient enrolment"
  • NCT03423355
    withdrawn; "change in sponsor"
  • NCT03537131
    terminated; "Temporary halt due to COVID-19 pandemic"
  • NCT03608358
    terminated; "Sponsor decided to stop commercialization of QTERNMet/Qtrilmet and to stop all related ongoing activities/studies for business reasons."
  • NCT03660683
    terminated; "Sponsor did not want to continue funding the study"
  • NCT03766750
    withdrawn; "Sponsor decision"
  • NCT04234867
    terminated; "slow recruitment"
  • NCT04330079
    terminated; "Slow enrollment. (Difficulty in selecting subjects)"
  • NCT04492722
    terminated; "The Sponsor decided to terminate the study early due to lack of efficacy. There were no safety concerns related to the study."
  • NCT04640493
    withdrawn; "Lack of enrollment"
  • NCT04764097
    withdrawn; "Lack of funding and similar competing study being conducted in Europe."
  • NCT04782245
    withdrawn; "New recommandations"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of DAPAGLIFLOZIN PROPANEDIOL used Dapagliflozin 10 mg — over how long?


Human studies of DAPAGLIFLOZIN PROPANEDIOL used "Dapagliflozin 10 mg". ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; tablet; also "Dapagliflozin 5 mg", "Farxiga 10 mg", "Dapagliflozin 10mg"

Show the evidence

human

  • NCT01730534
    Dapagliflozin 10 mg
  • NCT02157298
    Dapagliflozin 5 mg
  • NCT02338193
    Farxiga 10 mg
  • NCT02582814
    Dapagliflozin 10mg
  • NCT02777073
    Dapagliflozin 10mg Tab
  • NCT02946632
    dapagliflozin 10mg
14 more recorded rows
  • human NCT03138356
    tablet; 5 mg Forxiga® (dapagliflozin) tablet
  • human NCT03190694
    Placebo Matching Dapagliflozin 10mg
  • human NCT03387683
    Forxiga 10mg
  • human NCT03398577
    Dapagliflozin 10 MG [Farxiga]
  • human NCT03608358
    Dapagliflozin 10 mg placebo to match
  • human NCT03887416
    Dapagliflozin 10 MG Oral Tablet [Farxiga]
  • human NCT03970044
    Farxiga 10 MG
  • human NCT03982381
    Dapagliflozin 10 MG
  • human NCT04004793
    Dapagliflozin 10 MG Oral Tablet
  • human NCT04255238
    Forxiga tab 10mg
  • human NCT04333823
    FORXIGA 5mg
  • human NCT04806633
    Dapagliflozin 5mg
  • human NCT04880993
    Farxiga® 10 mg tablets
  • human NCT05179668
    Forxiga 10 MG

recorded 2026-09-01 · last checked 2026-09-04

Could one person measure DAPAGLIFLOZIN PROPANEDIOL's effect on hba1c compared to placebo?


Hba1c compared to placebo: measured in DAPAGLIFLOZIN PROPANEDIOL's trials.

hba1c compared to placebo is the recorded endpoint.

Show the evidence

biomarkers

  • hba1c compared to placebo; 2026-09-01
  • aes vital signs physical exam; 2026-09-01
  • ecgs; 2026-09-01
  • clinical labs; 2026-09-01
  • urine safety markers; 2026-09-01
  • blood and urine pk samples; 2026-09-01
14 more recorded rows
  • biomarkers
    iohexol pk blood urine samples for gfr assessment; 2026-09-01
  • biomarkers
    adjusted mean change in hba1c levels; 2026-09-01
  • biomarkers
    electronic measures of heart beats; 2026-09-01
  • biomarkers
    urinary glucose excretion dynamics; 2026-09-01
  • biomarkers
    adjusted mean change in total body weight; 2026-09-01
  • biomarkers
    oral bioavailability; 2026-09-01
  • biomarkers
    calculation of derivation of pharmacokinetic variables; 2026-09-01
  • biomarkers
    adjusted mean change from baseline in hemoglobin at week 12; 2026-09-01
  • biomarkers
    glycosylated haemoglobin a1c; 2026-09-01
  • biomarkers
    adverse events; 2026-09-01
  • biomarkers
    serious adverse events; 2026-09-01
  • biomarkers
    at least one episode of hypoglycemia; 2026-09-01
  • biomarkers
    hematocrit; 2026-09-01
  • biomarkers
    alanine aminotransferase; 2026-09-01
  • human trials at or under30
    74
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    0; NCT02719132; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of 7 glucose monitoring at day 7, adjusted mean change from baseline in hba1c levels and adjusted mean change from baseline in hemoglobin at week 12 did DAPAGLIFLOZIN PROPANEDIOL's trials measure?


7 glucose monitoring at day 7, adjusted mean change from baseline in hba1c levels and adjusted mean change from baseline in hemoglobin at week 12 lead 40 outcome terms across DAPAGLIFLOZIN PROPANEDIOL's trials. ClinicalTrials.gov · 2026-09-01

clinical labs, urine safety markers, blood and urine pk samples, iohexol pk blood urine samples for gfr assessment, adjusted mean change in hba1c levels and electronic measures of heart beats follow.

Show the evidence
  • hba1c compared to placebo
    1
  • aes vital signs physical exam
    1
  • ecgs
    1
  • clinical labs
    1
  • urine safety markers
    1
  • blood and urine pk samples
    1
14 more recorded rows
  • iohexol pk blood urine samples for gfr assessment
    1
  • adjusted mean change in hba1c levels
    1
  • electronic measures of heart beats
    1
  • urinary glucose excretion dynamics
    1
  • adjusted mean change in total body weight
    1
  • oral bioavailability
    1
  • calculation of derivation of pharmacokinetic variables
    1
  • adjusted mean change from baseline in hemoglobin at week 12
    1
  • glycosylated haemoglobin a1c
    1
  • adverse events
    1
  • serious adverse events
    1
  • at least one episode of hypoglycemia
    1
  • hematocrit
    1
  • alanine aminotransferase
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of DAPAGLIFLOZIN PROPANEDIOL's 35 ongoing trials reports first?


35 registered trials of DAPAGLIFLOZIN PROPANEDIOL are open; earliest completion 2024-05. ClinicalTrials.gov · 2026-09-01

Determination of the variability of HbA1c (by measurement of standard deviation of HbA1c) between the 2 diabetes treatment thresholds; Beta cell function; latest 2029-10-01

Show the evidence

Trial

  • NCT02879409
    "HbA1c Variability in Type II Diabetes"; n 150; "Determination of the variability of HbA1c (by measurement of standard deviation of HbA1c) between the 2 diabetes treatment thresholds"; 2026-10-01
  • NCT02969798
    "Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)"; n 700; "Beta cell function"; 2027-07
  • NCT03762850
    "A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy"; n 406; "Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36"; 2026-07
  • NCT03899402
    "Triple Therapy in T1DM"; n 78; "Change in HbA1c following dapagliflozin"; 2026-06-30
  • NCT04278404
    "Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)"; n 5000; "Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling"; 2026-12
  • NCT04333823
    "Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial"; n 100; "Measured Glomerular Filtration Rate (mGFR)"; 2024-05
14 further recorded trials
  • NCT04451837
    "Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology"; n 200; "Hba1c"; 2026-12-31
  • NCT04662723
    "Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy."; n 878; "-Proteinuria reduction within 6 months in IgAN patients with active renal lesions"; 2028-12-31
  • NCT05220917
    "Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study"; n 781430; "MACE"; 2027-09-30
  • NCT05321706
    "DAPAgliflozin for Renal Protection in Heart Transplant Recipients"; n 430; "The chronic slope of the eGFR"; 2028-11-30
  • NCT05374291
    "The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD"; n 1750; "Number of partipants with all-cause mortality, kidney failure, and hospitalization for heart failure"; 2027-07
  • NCT05590143
    "proMoting Effective Renoprotection in Cardiac sURgery Patients by Inhibition of SGLT-2"; n 784; "AKI"; 2025-09
  • NCT05764057
    "DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction"; n 450; "Change in left ventricular ejection fraction (LVEF) from baseline to Month 6 (±1 month) by TTE"; 2026-10-12
  • NCT05852704
    "SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF"; n 800; "Incidence of new onset post-operative atrial fibrillation of at least 30 seconds"; 2028-12-04
  • NCT05938712
    "The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients"; n 20; "Proximal tubular natriuresis with combination therapy"; 2028-03-01
  • NCT06000462
    "The Effect of Dapagliflozin on Weight Loss in Obese Adults Without Diabetes"; n 150; "Difference in inter-arms percent of subjects achieving ≥5% reduction in baseline weight"; 2025-12-30
  • NCT06155604
    "SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease"; n 150; "eGFR reduction"; 2026-12-31
  • NCT06304857
    "CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL"; n 188; "Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months."; 2027-12-31
  • NCT06317051
    "Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)"; n 300; "To assess the impact of dapagliflozin vs. placebo on weight reduction"; 2027-12
  • NCT06434025
    "IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency"; n 99; "left ventricular function assessed (LVEF) by CMR."; 2026-11-24

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of DAPAGLIFLOZIN PROPANEDIOL could settle lifespan?


NCT05374291 measures Number of partipants with all-cause mortality, kidney failure, and hospitalization for heart failure, reading out 2027-07.

1 open trial; n 1750; "The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD"

Show the evidence
  • Trial NCT05374291
    "The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD"; n 1750; "Number of partipants with all-cause mortality, kidney failure, and hospitalization for heart failure"; 2027-07

Which 95 trials of DAPAGLIFLOZIN PROPANEDIOL posted no result?


Posted no result
95 of 95 completed trials
Registrations
NCT00162305, NCT00263276, NCT00546741, NCT00688493, NCT00538174 and NCT00562250, and 89 more
Completion dates
oldest 2005-08; newest 2024-09-02
Show the evidence

Trial

  • NCT00162305
    2005-08
  • NCT00263276
    2007-02
  • NCT00546741
    2008-02
  • NCT00688493
    2008-04
  • NCT00538174
    2008-05
  • NCT00562250
    2008-08
14 further recorded trials
  • NCT00554450
    2008-10
  • NCT00839683
    2009-03
  • NCT00842556
    2009-05
  • NCT00904176
    2009-08
  • NCT00908271
    2009-08
  • NCT00930865
    2009-09
  • NCT01002807
    2010-01
  • NCT01055652
    2010-04
  • NCT01055691
    2010-04
  • NCT01072578
    2010-04
  • NCT01135446
    2010-06
  • NCT01156246
    2010-08
  • NCT01165268
    2010-12
  • NCT01877889
    2014-03

At the median, DAPAGLIFLOZIN PROPANEDIOL's trials enrolled 94 people — anything larger?


Median enrolment
94
Largest enrolment
781430
Registered trials counted
323

What do 3848 spontaneous reports say about DAPAGLIFLOZIN PROPANEDIOL — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

DAPAGLIFLOZIN PROPANEDIOL appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3848 reaction mentions were counted: diabetic ketoacidosis 1452; ketoacidosis 456; euglycaemic diabetic ketoacidosis 284; acute kidney injury 275. open-targets-adr · CHEMBL2103802 · 2026-06-24

Show the evidence
  • diabetic ketoacidosis
    1452
  • ketoacidosis
    456
  • euglycaemic diabetic ketoacidosis
    284
  • acute kidney injury
    275
  • weight decreased
    272
  • urinary tract infection
    262
4 more recorded rows
  • dehydration
    241
  • fungal infection
    237
  • blood glucose increased
    204
  • metabolic acidosis
    165

recorded 2026-06-24 · last checked 2026-09-04

DAPAGLIFLOZIN PROPANEDIOL and OAT3, P-GP and OAT1: shared by which compounds?


OAT3, P-GP and OAT1 appear in DAPAGLIFLOZIN PROPANEDIOL's recorded interaction sentences, 1 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP1A2 pharmacokinetics
    Drug Interactions In Vitro Assessment of Drug Interactions In in vitro studies, dapagliflozin and dapagliflozin 3-O-glucuronide neither inhibited CYP 1A2, 2C9, 2C19, 2D6, or 3A4, nor induced CYP 1A2, 2B6, or 3A4.

recorded 2026-08-30 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2103802
PubChem CID
24906252
CAS number
960404-48-2
RxCUI
1486966
InChIKey
JVHXJTBJCFBINQ-ADAARDCZSA-N

Relations

Development code
BMS-512148-05
Also called
Dapagliflozin compound with (2s)-1,2-propanediol hydrate, Dapagliflozin propanediol monohydrate, Dapagliflozin
Trade name
Dapagliflozin propanediol component of xigduo, Edistride, Farxiga, Forxiga
Japanese name
Dapagliflozin propylene glycolate hydrate
Salt form
Dapagliflozin || Metformin
Sources (7)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC and ClinicalTrials.gov organism ladder ·
  • open-targets-adr CHEMBL2103802 ·
  • openfda-label+europepmc COMBO:{IK:DNIAPMSPPWPWGF-VKHMYHEASA-N,K1:1ULL0QJ8UC} ·
1 more source

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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