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ERTUGLIFLOZIN PIDOLATE

  • 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 ERTUGLIFLOZIN PIDOLATE does in the body

STEGLATRO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Why people take it. STEGLATRO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · MLU731K321 · read 2026-08-29

  • Its recorded molecular formula is C27H32ClNO10, weighing 566.00.

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · read 2026-08-30

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 94 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

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.

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 34 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 moved4 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
24 hour weighted mean glucose; hba1c at week 12; urinary glucose excretion; variation in hba1c values

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
4 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 First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study)

The study did not show it

Who was studied
NCT01986881
How many people
8246
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

21 Day Organ Support (Respiratory or Vasopressor) Free Days

The study did not show it

Who was studied
NCT04505774
How many people
3591
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach

The study did not show it

Who was studied
NCT01999218
How many people
1326
Study design
Phase 3
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Change From Baseline in A1C at Week 26: Excluding Rescue Approach

The study did not show it

Who was studied
NCT02099110
How many people
1233
Study design
Phase 3
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Glycemic Control as Measured by HbA1c Levels

The study did not show it

Who was studied
NCT06449235
How many people
938
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Change From Baseline in A1C at Week 26 (Excluding Rescue Approach)

The study did not show it

Who was studied
NCT02033889
How many people
621
Study design
Phase 3
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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • Europe PMC · 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. 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.9 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 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.

  • 24 hour weighted mean glucose
  • baseline hemoglobin a1c
  • hba1c at week 12
  • urinary glucose excretion
  • hemoglobin a1c at week 18 excluding rescue approach
  • hemoglobin a1c at week 52 excluding rescue approach
  • hemoglobin a1c at week 26
  • hemoglobin a1c at week 24
  • variation in hba1c values

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 (25)
  • experiencing an adverse event
  • discontinuing study drug due to an ae
  • apparent volume of distribution
  • a1c at week 26
  • discontinuing study treatment due to an ae
  • a1c at week 26 excluding rescue approach
  • who experienced an adverse event
  • who discontinued study treatment due to an ae
  • experiencing an adverse event up to week 106
  • discontinuing study treatment due to an ae up to week 104
  • who experienced an adverse event including rescue approach
  • fractional excretion of sodium
  • muscle sympathetic nerve activity
  • left ventricular global longitudinal strain
  • who experienced an adverse event up to week 24
  • who experienced an ae up to week 54
  • who discontinued study treatment due to an ae up to week 24
  • who discontinued study treatment due to an ae up to week 54
  • 21 day organ support free days
  • mace

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

No description of who was studied is recorded.

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: “Safety and effectiveness of STEGLATRO in pediatric patients under 18 years of age have not been established.”

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · read 2026-08-30

  • On older people, the label states: “No dosage adjustment of STEGLATRO is recommended based on age.”

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · read 2026-08-30

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

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Data The lacteal excretion of radiolabeled ertugliflozin in lactating rats was evaluated 10 to 12 days after parturition.”

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage adjustment of STEGLATRO is necessary in patients with mild or moderate hepatic impairment.”

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · read 2026-08-30

  • On people with reduced kidney function, the label states: “A 26-week placebo-controlled study of 313 patients with Stage 3 Chronic Kidney Disease (eGFR ≥30 to less than 60 mL/min/1.73 m 2 ) treated with STEGLATRO did not demonstrate improvement in glycemic control.”

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · 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 2 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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

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.

ERTUGLIFLOZIN PIDOLATE appears in spontaneous reports to regulators. Across the 9 most-reported reaction terms, 61 reaction mentions were counted. One report can name several reactions.

The recorded terms (9)
  • product dose omission issue — 14 reaction mentions
  • diabetic ketoacidosis — 11 reaction mentions
  • blood glucose increased — 8 reaction mentions
  • euglycaemic diabetic ketoacidosis — 8 reaction mentions
  • ketoacidosis — 7 reaction mentions
  • fournier's gangrene — 6 reaction mentions
  • blood glucose abnormal — 3 reaction mentions
  • diabetic metabolic decompensation — 2 reaction mentions
  • inability to afford medication — 2 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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

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

  • 4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.

    FDA National Drug Code directory · 66651-926 · read 2026-08-29

  • They are sold as powder.

    FDA National Drug Code directory · 66651-926 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · read 2026-08-29

  • STEGLATRO is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, pink, triangular-shaped debossed with "701" on one side and plain on the other side., recorded as fda label in effect 2026-06-03 in the United States.

    US prescribing information · e6f3e718-bb99-48f1-ab94-b9f0af05fed6 · 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

  • Contains

    Ertugliflozin

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

  • Contains

    Pidolic acid

    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 ERTUGLIFLOZIN PIDOLATE 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

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 ERTUGLIFLOZIN PIDOLATE 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)
MLU731K321
RxNorm concept
1992810

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: Quoted from a stored source.

  • 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

  • 6 approved applications cover products containing this substance. The earliest was NDA209803, approved 20171219 to MSD SUB MERCK.

    Drugs@FDA application register · NDA209803 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA209803 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20170126.

    FDA National Drug Code directory · 66651-926 · 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.

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What is not here

6 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.

  • The path through the body — found nothing in the sources checked.
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  • Other ways to the same goal — found nothing in the sources checked.
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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.

Recorded evidence blocks (11)

What did ERTUGLIFLOZIN PIDOLATE's largest trial (781430 people) and its longest (6.2 years) measure?


781430 people in ERTUGLIFLOZIN PIDOLATE's largest registered study, 6.2 years in its longest registered window, measuring Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin. ClinicalTrials.gov · 2026-09-01

14 phase3, 10 phase4, 8 phase1, 4 phase2, 2 na or unstated, 1 early phase1; NCT05220917; 2027-09-30; no ageing endpoint recorded. Last human test completed 2025, NCT05727579.

Interpretation These counts include studies where ERTUGLIFLOZIN PIDOLATE 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
  • phase3
    14
  • phase4
    10
  • phase1
    8
  • phase2
    4
  • na or unstated
    2
  • early phase1
    1
1 more recorded row
  • Last recorded human test NCT05727579
    2025-11-30

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

ERTUGLIFLOZIN PIDOLATE was tested only in human — what did it show?


human: biomarker (39): the rungs where ERTUGLIFLOZIN PIDOLATE has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT00989079
    biomarker; Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin; 39

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

4 of ERTUGLIFLOZIN PIDOLATE's trials stopped: accrual/recruitment, funding/business?


accrual/recruitment (3) and funding/business (1): ERTUGLIFLOZIN PIDOLATE's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Study withdrawn prior to IRB approval and enrollment"; 4 of 39 registered studies

Show the evidence

Trial

  • NCT03640221
    withdrawn; "Study withdrawn prior to IRB approval and enrollment"
  • NCT03813316
    withdrawn; "Lack of funding availability to complete project"
  • NCT04071626
    terminated; "Lack of enrollment"
  • NCT04600921
    terminated; "The feasibility (recruitment) of the high number of patients (402 patients with HFrEF or HFmrEF) was impossible due to the rapid increase in SGLT2 inhibitors in patients with heart failure."

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

Human studies of ERTUGLIFLOZIN PIDOLATE used Ertugliflozin 1 mg — over how long?


Human studies of ERTUGLIFLOZIN PIDOLATE used "Ertugliflozin 1 mg". ClinicalTrials.gov · 2026-09-01

8 recorded entries; human; tablet; also "Ertugliflozin 10 mg tablet", "Ertugliflozin 10 mg", "Ertugliflozin 15 mg"

Show the evidence

human

  • NCT01059825
    Ertugliflozin 1 mg
  • NCT01114568
    tablet; Ertugliflozin 10 mg tablet
  • NCT01958671
    Ertugliflozin 10 mg
  • NCT02033889
    Ertugliflozin 15 mg
  • NCT02099110
    Matching Placebo to Ertugliflozin 10 mg
  • NCT04029480
    Placebo to ertugliflozin 15 mg
2 more recorded rows
  • human NCT04071626
    Ertugliflozin 5 mg
  • human NCT05644717
    Ertugliflozin 5 mg, 15mg

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

Could one person measure ERTUGLIFLOZIN PIDOLATE's effect on experiencing an adverse event?


Experiencing an adverse event: measured in ERTUGLIFLOZIN PIDOLATE's trials.

Interpretation experiencing an adverse event is the recorded endpoint.

Show the evidence

biomarkers

  • experiencing an adverse event; 2026-09-01
  • discontinuing study drug due to an ae; 2026-09-01
  • apparent volume of distribution; 2026-09-01
  • 24 hour weighted mean glucose; 2026-09-01
  • baseline hemoglobin a1c; 2026-09-01
  • hba1c at week 12; 2026-09-01
14 more recorded rows
  • biomarkers
    urinary glucose excretion; 2026-09-01
  • biomarkers
    a1c at week 26; 2026-09-01
  • biomarkers
    discontinuing study treatment due to an ae; 2026-09-01
  • biomarkers
    a1c at week 26 excluding rescue approach; 2026-09-01
  • biomarkers
    who experienced an adverse event; 2026-09-01
  • biomarkers
    who discontinued study treatment due to an ae; 2026-09-01
  • biomarkers
    hemoglobin a1c at week 18 excluding rescue approach; 2026-09-01
  • biomarkers
    hemoglobin a1c at week 52 excluding rescue approach; 2026-09-01
  • biomarkers
    experiencing an adverse event up to week 106; 2026-09-01
  • biomarkers
    discontinuing study treatment due to an ae up to week 104; 2026-09-01
  • biomarkers
    hemoglobin a1c at week 26; 2026-09-01
  • biomarkers
    who experienced an adverse event including rescue approach; 2026-09-01
  • biomarkers
    fractional excretion of sodium; 2026-09-01
  • biomarkers
    muscle sympathetic nerve activity; 2026-09-01
  • human trials at or under30
    10
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    0; NCT03640221; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of 21 day organ support free days, 24 hour weighted mean glucose and a1c at week 26 did ERTUGLIFLOZIN PIDOLATE's trials measure?


21 day organ support free days, 24 hour weighted mean glucose and a1c at week 26 lead 34 outcome terms across ERTUGLIFLOZIN PIDOLATE's trials. ClinicalTrials.gov · 2026-09-01

24 hour weighted mean glucose, baseline hemoglobin a1c, hba1c at week 12, urinary glucose excretion, a1c at week 26 and discontinuing study treatment due to an ae follow.

Show the evidence
  • experiencing an adverse event
    1
  • discontinuing study drug due to an ae
    1
  • apparent volume of distribution
    1
  • 24 hour weighted mean glucose
    1
  • baseline hemoglobin a1c
    1
  • hba1c at week 12
    1
14 more recorded rows
  • urinary glucose excretion
    1
  • a1c at week 26
    1
  • discontinuing study treatment due to an ae
    1
  • a1c at week 26 excluding rescue approach
    1
  • who experienced an adverse event
    1
  • who discontinued study treatment due to an ae
    1
  • hemoglobin a1c at week 18 excluding rescue approach
    1
  • hemoglobin a1c at week 52 excluding rescue approach
    1
  • experiencing an adverse event up to week 106
    1
  • discontinuing study treatment due to an ae up to week 104
    1
  • hemoglobin a1c at week 26
    1
  • who experienced an adverse event including rescue approach
    1
  • fractional excretion of sodium
    1
  • muscle sympathetic nerve activity
    1

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

Which of ERTUGLIFLOZIN PIDOLATE's 6 ongoing trials reports first?


6 registered trials of ERTUGLIFLOZIN PIDOLATE are open; earliest completion 2025-12-01. ClinicalTrials.gov · 2026-09-01

Change from baseline to day 7 of plasma volume by add-on to loop diuretic therapy; MACE; latest 2029-03-31

Show the evidence

Trial

  • NCT04438213
    "Ertugliflozin in Chronic Heart Failure"; n 60; "Change from baseline to day 7 of plasma volume by add-on to loop diuretic therapy"; 2025-12-30
  • NCT05220917
    "Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study"; n 781430; "MACE"; 2027-09-30
  • NCT05644717
    "Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD"; n 164; "Radiologic liver parameters"; 2025-12-01
  • NCT05662865
    "Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers"; n 9; "Fasting ketones"; 2026-12
  • NCT07547878
    "Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)"; n 64; "On-study retention rate at 6 months"; 2029-03-31
  • NCT07621380
    "Ertugliflozin's Effect on Heart Function in Diabetic Patients After Myocardial Infarction"; n 476; "Percent change in NT-proBNP from baseline"; 2028-03-01

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

Which 7 trials of ERTUGLIFLOZIN PIDOLATE posted no result?


Posted no result
7 of 7 completed trials
Registrations
NCT00989079, NCT01018823, NCT01114568, NCT01127308, NCT01223339 and NCT04027530, and 1 more
Completion dates
oldest 2009-12-11; newest 2023-10-27
Show the evidence

Trial

  • NCT00989079
    2009-12-11
  • NCT01018823
    2010-03-18
  • NCT01114568
    2010-06
  • NCT01127308
    2010-07
  • NCT01223339
    2011-02
  • NCT04027530
    2023-01-09
  • 1 further recorded trial NCT05152940
    2023-10-27

At the median, ERTUGLIFLOZIN PIDOLATE's trials enrolled 64 people — anything larger?


Median enrolment
64
Largest enrolment
781430
Registered trials counted
39

What do 61 spontaneous reports say about ERTUGLIFLOZIN PIDOLATE — 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.

ERTUGLIFLOZIN PIDOLATE appears in spontaneous reports to regulators. Across the 9 most-reported reaction terms, 61 reaction mentions were counted: product dose omission issue 14; diabetic ketoacidosis 11; blood glucose increased 8; euglycaemic diabetic ketoacidosis 8. open-targets-adr · CHEMBL5315054 · 2026-06-24

Show the evidence
  • product dose omission issue
    14
  • diabetic ketoacidosis
    11
  • blood glucose increased
    8
  • euglycaemic diabetic ketoacidosis
    8
  • ketoacidosis
    7
  • fournier's gangrene
    6
3 more recorded rows
  • blood glucose abnormal
    3
  • diabetic metabolic decompensation
    2
  • inability to afford medication
    2

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

Was ERTUGLIFLOZIN PIDOLATE studied with fasting and exercise?


fasting and exercise are named in ERTUGLIFLOZIN PIDOLATE's label sentences: "Ertugliflozin was also superior to placebo in lowering fasting plasma glucose (FPG), body weight, and systolic and diastolic blood pressure (BP)." openfda-label+europepmc · 2026-08-30

2 recorded statements; fasting, exercise

Show the evidence
  • fasting
    Ertugliflozin was also superior to placebo in lowering fasting plasma glucose (FPG), body weight, and systolic and diastolic blood pressure (BP).
  • exercise
    This study assessed the efficacy and safety of co-initiation of ertugliflozin and sitagliptin compared with placebo in patients with T2DM inadequately controlled on diet and exercise.

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL5315054
PubChem CID
57339449
CAS number
1210344-83-4
RxCUI
1992674
InChIKey
MCIACXAZCBVDEE-CUUWFGFTSA-N

Relations

Also called
Ertugliflozin, Ertugliflozin l-pyroglutamic acid, sglt2i
Trade name
Ertugliflozin pidolate component of segluromet, Ertugliflozin pidolate component of steglujan, Steglatro
Sources (9)

Sources

3 more sources

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: 4 required field(s) not terminal: 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: 9 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

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.