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Dapagliflozin

  • Research compound
  • Still being tested
  • 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 does in the body

Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.

From the FDA-approved label: Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion.

Why people take it. The risk of hospitalization for heart failure

What happened in people

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

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · 887K2391VH · read 2026-08-29

  • Its recorded molecular formula is C21H25ClO6•C3H8O2, weighing 502.99.

    US prescribing information · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · 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.

No statement of the main limit is recorded.

The four opening statements run to 83 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.

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.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

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 moved10 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
10 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.

Time to the first occurrence of any of the components of the composite: all-cause mortality, hospitalization for heart failure, hospitalization for myocardial infarction, hospitalization for ischemic stroke, and incident or worsening nephropathy.

The study did not show it

Who was studied
NCT06642272
How many people
17200
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke

The study did not show it

Who was studied
NCT01730534
How many people
17190
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death

The study did not show it

Who was studied
NCT06677060
How many people
11300
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

10-year CVD risk

The study did not show it

Who was studied
NCT07679828
How many people
8252
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Rates of a composite cardiovascular endpoint

The study did not show it

Who was studied
NCT05700877
How many people
7300
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality

The study did not show it

Who was studied
NCT07753993
How many people
7000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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. 2 written-up studies 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 Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Drosophila (fruit fly), Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  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 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 it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 12.9 hours hours

    Read from the label, which states: “The mean plasma terminal half-life (t ½ ) for dapagliflozin is approximately 12.9 hours following a single oral dose of dapagliflozin 10 mg.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

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.

  • Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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.

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 · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · read 2026-08-30

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

    US prescribing information · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · 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 · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · 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 · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · 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 · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Dapagliflozin 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 · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · read 2026-08-30

Where the result stopped carrying

  • 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

Still being tested

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

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

Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.

Quoted from a source

Where this came from

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

The identity record classes it as investigational; no register records an approval.

No source is stored against this line.

What is in the pack

Sold as tablet, film coated, extended release, tablet, film coated, given by the oral route.

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 takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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 appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2234 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • diabetic ketoacidosis — 769 reaction mentions
  • fungal infection — 211 reaction mentions
  • ketoacidosis — 190 reaction mentions
  • acute kidney injury — 186 reaction mentions
  • euglycaemic diabetic ketoacidosis — 183 reaction mentions
  • weight decreased — 168 reaction mentions
  • urinary tract infection — 157 reaction mentions
  • blood glucose increased — 135 reaction mentions
  • dehydration — 119 reaction mentions
  • metabolic acidosis — 116 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

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 53 products list this as an active ingredient in the United States drug directory. 41 of them contain it and nothing else.

    FDA National Drug Code directory · 0310-6350 · read 2026-08-29

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

    FDA National Drug Code directory · 0310-6350 · 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 · 0310-6350 · read 2026-08-29

  • 10 published labels name it as an active ingredient. 8 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · read 2026-08-29

  • DAPAGLIFLOZIN is oral at 3 DOSAGE FORMS AND STRENGTHS Dapagliflozin Tablets USP: 5 mg, pink, biconvex, round, film-coated tablets with “C388” engraved on one side and plain on the other side. 10 mg, pink, biconvex, diamond-shaped, film-coated t…, recorded as fda label in effect 2026-06-22 in the United States.

    US prescribing information · a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 · read 2026-08-30

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

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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine, investigational agent. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Dapagliflozin 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?

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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 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.

Where else this substance is registered

FDA substance identifier (UNII)
887K2391VH
CAS registry number
960404-48-2
PubChem compound
24906252
ChEMBL
CHEMBL429910
ChEBI
85079
RxNorm concept
1486966
EMA substance identifier
100000140964
DrugBank
DBSALT001101

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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

  • The earliest marketing start date recorded for a listed product is 20080114.

    FDA National Drug Code directory · 0310-6350 · read 2026-08-29

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Recorded evidence blocks (15)

What did Dapagliflozin's largest trial (1249636 people) and its longest (13 years) measure?


1249636 people in Dapagliflozin'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

154 phase4, 135 phase3, 95 phase2, 58 phase1, 34 na or unstated, 22 na, 5 early phase1; NCT02969798; 2027-07. Last human test completed 2026, NCT07076615.

Interpretation These counts include studies where Dapagliflozin 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
    154
  • phase3
    135
  • phase2
    95
  • phase1
    58
  • na or unstated
    34
  • na
    22
2 more recorded rows
  • early phase1
    5
  • Last recorded human test NCT07076615
    2026-05-31

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

From C. elegans to human: where has Dapagliflozin shown lifespan?


C. elegans: lifespan, Drosophila: mechanism-only, mouse: biomarker, rat: mechanism-only and human: lifespan (480): the rungs where Dapagliflozin 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 lifespanDrosophila mechanism-onlyMouse biomarkerRat mechanism-onlyDog Non-human primate Human lifespan
Show the evidence
  • C. elegans
    lifespan
  • Drosophila
    mechanism-only
  • mouse
    biomarker
  • rat
    mechanism-only
  • human NCT03249506
    lifespan; Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF); 480

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

27 of Dapagliflozin's trials stopped: safety, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (2), accrual/recruitment (11), funding/business (6), sponsor decision unspecified (2) and other (6): Dapagliflozin's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"FSI delayed until 15 January 2013"; 27 of 480 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 used Dapagliflozin 10 mg — over how long?


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

20 recorded entries; human; tablet; also "Dapagliflozin 5 mg", "Xigduo 5mg/1000 mg", "Farxiga 10 mg"

Show the evidence

human

  • NCT01730534
    Dapagliflozin 10 mg
  • NCT02157298
    Dapagliflozin 5 mg
  • NCT02338193
    Xigduo 5mg/1000 mg
  • NCT02338193
    Farxiga 10 mg
  • NCT02547935
    Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
  • NCT02582814
    Dapagliflozin 10mg
14 more recorded rows
  • human NCT02582840
    Dapagliflozin 5mg
  • human NCT02682563
    Dapagliflozin 10mg QD
  • human NCT02777073
    Dapagliflozin 10mg Tab
  • human NCT02946632
    dapagliflozin 10mg
  • human NCT03030235
    Dapagliflozin 10Mg Oral Tablet
  • human NCT03138356
    tablet; 2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet
  • human NCT03138356
    tablet; 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet
  • human NCT03138356
    5 mg dapagliflozin / 850 mg metformin XR FDC
  • human NCT03138356
    5 mg dapagliflozin / 1000 mg metformin XR FDC
  • 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 NCT03537131
    Dapagliflozin 10 MG Oral Tablet

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

Dapagliflozin's half-life is 12.9 hours — which schedules were studied?


12.9 hours, the half-life Dapagliflozin's label states. openfda-label · 8296f538-4c23-4d6c-be53-8005b83c24b7 · 2026-08-30

Show the evidence
  • half life
    12.9 hours hours; The mean plasma terminal half-life (t ½ ) for dapagliflozin is approximately 12.9 hours following a single oral dose of dapagliflozin 10 mg.
  • tmax
    Administration of dapagliflozin with a high-fat meal decreases its C max by up to 50% and prolongs T max by approximately 1 hour but does not alter AUC as compared with the fasted state.
  • bioavailability
    The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%.
  • metabolism
    Metabolism The metabolism of dapagliflozin is primarily mediated by UGT1A9; CYP-mediated metabolism is a minor clearance pathway in humans.

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

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


Hba1c compared to placebo: measured in Dapagliflozin'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
  • half life
    2026-09-04; halfLife; hours; 12.9 hours; 2026-08-30
  • human trials at or under30
    95
  • 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'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'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's 112 ongoing trials reports first?


112 registered trials of Dapagliflozin 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 2031-06-30

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
  • NCT05345327
    "SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes"; n 994; "Rate of decline in eGFR"; 2026-06-30
  • NCT05359263
    "Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD"; n 222; "Change in LV mass index assessed by echocardiography at 6 months"; 2025-02-18
  • 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
  • NCT05521984
    "Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)"; n 20; "Number and type of adverse events experienced by participants"; 2031-06-30
  • NCT05590143
    "proMoting Effective Renoprotection in Cardiac sURgery Patients by Inhibition of SGLT-2"; n 784; "AKI"; 2025-09
  • NCT05719714
    "Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease"; n 18; "Left ventricular longitudinal strain (LVLS)"; 2026-09-30
  • 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
  • NCT05782972
    "Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study"; n 50; "Change of liver inflammatory marker"; 2025-12-31
  • 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
  • NCT05882071
    "Non-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France"; n 547150; "Baseline characteristic: Age"; 2026-08-31

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

Which running trial of Dapagliflozin could settle inflammatory markers?


NCT05782972 measures Change of liver inflammatory marker, reading out 2025-12-31.

10 open trials; n 50; "Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study"

Show the evidence

Trial

  • NCT05782972
    "Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study"; n 50; "Change of liver inflammatory marker"; 2025-12-31
  • NCT07295223
    "Effect of Glp-1 and Antidiabetic sgLT2 Agents for myoCardial infarcTion and Ultrasensitive Inflammatory Surveillance (GALACTUS Trial)"; n 44; "Inflammatory markers (high-sensitivity PCR)"; 2026-09
  • 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
  • NCT05989347
    "Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy"; n 20; "Change in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)"; 2027-12
  • NCT07325435
    "Beta Cell Function in Type 2 Diabetes: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists"; n 60; "Change in Stimulated C-peptide Index during an Oral Glucose Tolerance Test is a measure of Beta Cell Function and will be measuresd at baseline and at 16 weeks after treatment with GLP-1 Receptor Agonist or SGLT2-Inhibitor"; 2028-06-30
  • NCT07482943
    "The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure"; n 30; "Maximal oxygen uptake (VO2 max) on cardiopulmonary exercise (CPX) at 3 months"; 2028-07
4 further recorded trials
  • NCT07469722
    "POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure"; n 128; "Pairwise Comparisons With Wins of Clinical Benefit, a Composite of In-Hospital Mortality, Hospital Length of Stay, Absence of Congestion on DUCS at Discharge, and BNP Reduction From Admission to Day 7 or Discharge."; 2028-07-01
  • NCT06642272
    "A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record"; n 17200; "Time to the first occurrence of any of the components of the composite: all-cause mortality, hospitalization for heart failure, hospitalization for myocardial infarction, hospitalization for ischemic stroke, and incident or worsening…"; 2028-12-31
  • NCT07025629
    "Dapagliflozin for Cardio-renal Protection After ICU Discharge"; n 600; "All-cause mortality"; 2029-01-15
  • NCT07310433
    "Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer"; n 60; "Progression free survival"; 2030-10-30

Which 116 trials of Dapagliflozin posted no result?


Posted no result
116 of 116 completed trials
Registrations
NCT00162305, NCT00263276, NCT00546741, NCT00688493, NCT00538174 and NCT00562250, and 110 more
Completion dates
oldest 2005-08; newest 2024-09-03
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
  • NCT01165268
    2010-12
  • NCT01877889
    2014-03
  • NCT02060201
    2014-05

At the median, Dapagliflozin's trials enrolled 100 people — anything larger?


Median enrolment
100
Largest enrolment
1249636
Registered trials counted
480

What do 2234 spontaneous reports say about Dapagliflozin — 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 appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2234 reaction mentions were counted: diabetic ketoacidosis 769; fungal infection 211; ketoacidosis 190; acute kidney injury 186. open-targets-adr · CHEMBL429910 · 2026-06-24

Show the evidence
  • diabetic ketoacidosis
    769
  • fungal infection
    211
  • ketoacidosis
    190
  • acute kidney injury
    186
  • euglycaemic diabetic ketoacidosis
    183
  • weight decreased
    168
4 more recorded rows
  • urinary tract infection
    157
  • blood glucose increased
    135
  • dehydration
    119
  • metabolic acidosis
    116

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

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


OAT3, P-GP and OAT1 appear in Dapagliflozin's recorded interaction sentences, 1 in all. openfda-label+europepmc · 2026-08-31

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 2026-08-31 · last checked 2026-09-04

Was Dapagliflozin studied with fasting, caloric restriction and exercise?


fasting, caloric restriction and exercise are named in Dapagliflozin's label sentences: "Objective The study assessed the bioequivalence of a fixed-dose combination (FDC) of dapagliflozin 10 mg/pioglitazone 15 mg co-administered with the reference products Forxiga® 10 mg: AstraZeneca Pharmaceuticals LP, Indiana, USA and Pioglit® 15 mg: Sun Pharma Laboratories Ltd., Assam, India in…" openfda-label+europepmc · 2026-08-31

3 recorded statements; fasting, caloric restriction, exercise

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  • fasting
    Objective The study assessed the bioequivalence of a fixed-dose combination (FDC) of dapagliflozin 10 mg/pioglitazone 15 mg co-administered with the reference products Forxiga® 10 mg: AstraZeneca Pharmaceuticals LP, Indiana, USA and Pioglit® 15 mg: Sun Pharma Laboratories Ltd., Assam, India in healthy adult participants under fasting conditions.
  • caloric restriction
    Calorie restriction with dapagliflozin 10 mg/day or placebo.
  • exercise
    This randomized study of SGLT2i in pre-capillary PH showed that 12 weeks of dapagliflozin did not significantly improve exercise capacity, hemodynamics, or functional status compared to placebo.

recorded 2026-08-31 · last checked 2026-09-04

What is recorded about Dapagliflozin and sirtuin?


"Dapagliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been demonstrated to possess cardioprotective effects; however, the interplay between sirtuin signaling and ferroptosis in dapagliflozin-mediated cardioprotection under doxorubicin-induced stress remains unclear." — where Dapagliflozin and sirtuin appear together. Europe PMC · pathway abstract search · 2026-07-20

sirtuin, AMPK, autophagy, mTOR, NAD+, IGF-1; PMID 42130718, 40350800, 42548880, 42345092

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sirtuin

  • PMID 42130718
    "Dapagliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been demonstrated to possess cardioprotective effects; however, the interplay between sirtuin signaling and ferroptosis in dapagliflozin-mediated cardioprotection under doxorubicin-induced stress remains unclear."
  • PMID 42130718
    "The cardioprotective efficacy of dapagliflozin under cellular stress depends critically on SIRT1/SIRT3 signaling and ferroptosis regulation, as pharmacological inhibition of these sirtuins abolished its protective potentials; conversely, these effects were enhanced by ferroptosis suppression and attenuated by its induction."
  • PMID 42130718
    "Furthermore, dapagliflozin-mediated inhibition of ferroptosis downregulated SIRT1/SIRT3 expression, suggesting a potential feedback mechanism under chemotherapeutic stress."
  • AMPK
    "Dapagliflozin activated the AMPK/SIRT1/SIRT3 signaling axis, upregulated autophagy/mitophagy markers (LC3B, BECN1, Parkin)."

autophagy

  • "Dapagliflozin activated the AMPK/SIRT1/SIRT3 signaling axis, upregulated autophagy/mitophagy markers (LC3B, BECN1, Parkin)."
  • "Conclusions These findings suggest that dapagliflozin protects cardiomyocytes through enhanced SIRT1/3-associated mitochondrial quality control and adaptive autophagy, providing mechanistic evidence supporting SGLT2 inhibitors' therapeutic potential in mitigating myocardial ischemic injury.</p>"
  • AMPK PMID 40350800
    "This study explores the molecular mechanisms by which dapagliflozin influences hepatic glucose and lipid metabolism, hypothesizing that it activates the 5'-adenosine monophosphate-activated protein kinase (AMPK)-sirtuin 1 (Sirt1) pathway to promote gluconeogenesis and reduce lipid accumulation via autophagy."
  • autophagy PMID 40350800
    "This study explores the molecular mechanisms by which dapagliflozin influences hepatic glucose and lipid metabolism, hypothesizing that it activates the 5'-adenosine monophosphate-activated protein kinase (AMPK)-sirtuin 1 (Sirt1) pathway to promote gluconeogenesis and reduce lipid accumulation via autophagy."
  • AMPK PMID 40350800
    "Dapagliflozin enhances hepatic gluconeogenesis and reduces steatosis by activating the AMPK-Sirt1 pathway and promoting autophagy."

mTOR

  • PMID 42548880
    "We summarize preclinical evidence suggesting that dapagliflozin can improve cognitive performance and modulate pathways such as AMPK-mTOR, Wnt/β-catenin, CREB/BDNF, oxidative stress responses, and neuroinflammatory signaling in experimental models, while also critically evaluating the limitations of these models."
  • PMID 42345092
    "Mechanistically, canagliflozin significantly increased AMPK (AMP-activated protein kinase) phosphorylation while decreasing AKT/mTORC1 (mechanistic target of rapamycin complex 1) activation compared with empagliflozin, dapagliflozin."
  • PMID 42345092
    "Empagliflozin and dapagliflozin promote EC-angiogenic functions through balanced AMPK/AKT/mTORC1 signaling, whereas canagliflozin impaired these processes via excessive AMPK activation and suppression of AKT/mTORC1 signaling."
  • NAD+ PMID 40178648
    "The current study aimed to determine the neuroprotective potential of Dapagliflozin against STZ-NAD-induced DN in Wistar rats via IGF-1 signaling."
  • IGF-1 PMID 40178648
    "The current study aimed to determine the neuroprotective potential of Dapagliflozin against STZ-NAD-induced DN in Wistar rats via IGF-1 signaling."
  • NAD+ PMID 40528600
    "In vitro, compared to the human umbilical vein endothelial cells of TNF-α group, the expression levels of interleukin-6, interleukin-1β and p-P65 proteins and messenger RNA of Bcl2, Nos3, Cdk8, Pde2a, Dlg1, Pdpk1, Tnks2, Baz2b, Pparg, Fas, Pde7a and Nampt were significantly lower than dapagliflozin high concentration group (<i>P</i> all<0.05). <b>Conclusions:</b> Dapagliflozin may inhibit…"

recorded 2026-07-20 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL429910
PubChem CID
9887712
CAS number
461432-26-8
RxCUI
1488564
InChIKey
JVHXJTBJCFBINQ-ADAARDCZSA-N

Relations

Development code
BMS-512148, LYN-045
Also called
Dapagliflozina, Dapagliflozine, br3006a, dapa, dapagliflozin 10 mg, dapaglifozin, gliflozins, isglt2, sglt-2 inhibitors, sglt-2i, sglt2, sglt2 inhibitors
Trade name
Dapagliflozin component of br1019, Dapagliflozin component of qtern, Dapagliflozin component of qternmet, Dapagliflozin component of qternmet dapaglifozin, Dapagliflozin component of qternmet xr, Dapagliflozin viatris, Farxiga, Dapagliflozin / Farxiga, DAPAGLIFLOZIN COMPONENT QTERNMET, QTERNMET XR COMPONENT DAPAGLIFLOZIN, Qtern, Edistride
Salt form
sodium-glucose cotransporter 2 inhibitors, Dapagliflozin 2,3-Butanediol Monohydrate
Sources (11)

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 dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

ChEMBL ATC CC BY-SA · 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

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