This page shows what was measured, who it was measured in, and what that does not settle.
What Sotagliflozin does in the body
The risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit
From the FDA-approved label: Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea. The mechanism for sotagliflozin's cardiovascular benefits has not been established.
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 · 6B4ZBS263Y · read 2026-08-29
Its recorded molecular formula is C21H25ClO5S, weighing 424.94.
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · read 2026-08-30
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 91 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.
What happened in people◇Read 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 36 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.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Blood sugar
∅Nothing 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 moved5 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
postprandial glucose; rate of glucose appearance after meal; urinary glucose excretion; hba1c at week 26; hba1c
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
5 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 people◇Read 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.
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
✗ The study did not show it
Who was studied
NCT03315143
How many people
10584
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 Drugs@FDA · a recorded source, not a stored snapshot
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
MACE + HHF
✗ The study did not show it
Who was studied
NCT06082063
How many people
2000
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. Oral
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
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
Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization
✗ The study did not show it
Who was studied
NCT02531035
How many people
1405
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. Oral
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
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
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
✗ The study did not show it
Who was studied
NCT03521934
How many people
1222
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 Drugs@FDA · a recorded source, not a stored snapshot
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
Change From Baseline in Hemoglobin A1c at Week 52
✗ The study did not show it
Who was studied
NCT03332771
How many people
954
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. Oral
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
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
Change From Baseline in A1C at Week 24
✗ The study did not show it
Who was studied
NCT02384941
How many people
793
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. Oral
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
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
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 people◇Read 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.
□Living longer, or avoiding a major eventNo 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.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.2 registered measures of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.2 registered measures of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.14 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo 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 take◇Read 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.
kansas city cardiomyopathy questionnaire clinical summary
Measured
Things only a test, a scale or a device shows.
maximum observed plasma concentration
postprandial glucose
rate of glucose appearance after meal
urinary glucose excretion
hemoglobin a1c at week 12
hemoglobin a1c at week 26
maximum plasma concentration
area under the concentration time curve from 0 to infinity
hba1c at week 26
hemoglobin a1c at week 18
and 6 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)
gut hormones
qtc intervals
adverse events
a1c at week 24
treatment emergent adverse events
assessment of midazolam pk parameter auc
assessment of metoprolol pk parameter auc
assessment of pk parameter auctau
assessment of pharmacodynamic parameters in feces
assessment of pd parameters in blood
cmax
mace + hhf
treatment related adverse events
on study retention rate at 6 months
sustained decline in egfr 30
uacr
markers of renal health
markes of cardio health
incidence of treatment emergent adverse events
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 take◇Read 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.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
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.
How fast the body clears it. 21 to 35 hours hours
Read from the label, which states: “Following administration of 200 mg and 400 mg, mean terminal half-life (T 1/2 ) ranged from 21 to 35 hours for sotagliflozin and from 19 to 26 hours for sotagliflozin 3-O-glucuronide.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
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 unclear◇Read 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.
INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors INPEFA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart…
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 INPEFA in pediatric patients under 18 years of age have not been established.”
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · read 2026-08-30
On older people, the label states: “No INPEFA dosage change is recommended based on age.”
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on animal data showing renal effects, INPEFA is not recommended during the second and third trimesters of pregnancy.”
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of INPEFA in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · read 2026-08-30
On people with reduced liver function, the label states: “The safety and efficacy of INPEFA have not been established in patients with moderate or severe hepatic impairment [see Clinical Pharmacology ( 12.3 )] .”
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · read 2026-08-30
On people with reduced kidney function, the label states: “INPEFA was evaluated in 5,292 patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m 2 ) in the SCORED study and in 426 patients with heart failure with eGFR < 60 mL/min/1.73 m 2 in the SOLOIST study.”
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · 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 take◇Read 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.
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 (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
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 take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as tablet, 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 take∅Nothing 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.
Sotagliflozin appears in spontaneous reports to regulators. Across the 1 most-reported reaction terms, 5 reaction mentions were counted. One report can name several reactions.
The recorded terms (1)
hypoglycaemia — 5 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 unclear◇Read 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
3 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.
FDA National Drug Code directory · 48087-0150 · read 2026-08-29
They are sold as powder and tablet, taken oral.
FDA National Drug Code directory · 48087-0150 · read 2026-08-29
The regulator's established pharmacologic class for it is p-glycoprotein inhibitors [moa], sodium-glucose cotransporter 2 inhibitor [epc] and sodium-glucose transporter 2 inhibitors [moa].
FDA National Drug Code directory · 48087-0150 · 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 · 1a46614e-05f6-421a-b6f4-d6f8760d643a · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · read 2026-08-29
INPEFA is oral at 3 DOSAGE FORMS AND STRENGTHS INPEFA 200 mg tablet is an oval, blue, film-coated tablet debossed with “LEX” on one side and “200” on the other side., recorded as fda label in effect 2026-08-12 in the United States.
US prescribing information · 1a46614e-05f6-421a-b6f4-d6f8760d643a · 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.
What it would be like to take◇Read 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 Sotagliflozin 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 unclear◇Read 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 Sotagliflozin 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 people◇Read 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)
6B4ZBS263Y
RxNorm concept
2638683
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
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How this medicine reached us
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What the approval register records
1 approved application covers products containing this substance. The earliest was NDA216203, approved 20230526 to LEXICON PHARMS INC.
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5 questions this page could not answer
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Recorded evidence blocks (14)
Q1
What did Sotagliflozin's largest trial (10584 people) and its longest (5.2 years) measure?
10584 people in Sotagliflozin's largest registered study, 5.2 years in its longest registered window, measuring Maximum observed plasma concentration. ClinicalTrials.gov · 2026-09-01
23 phase1, 19 phase3, 12 phase2, 3 phase4, 1 early phase1, 1 na or unstated; NCT07594145; 2031-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT06618976.
Interpretation These counts include studies where Sotagliflozin 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
phase1
23
phase3
19
phase2
12
phase4
3
early phase1
1
na or unstated
1
1 more recorded row
Last recorded human testNCT06618976
2026-02-10
recorded 2026-09-01 · last checked 2026-09-04
Q2
Sotagliflozin was tested only in human — what did it show?
"1st two cohorts provided the required data, therefore 3rd cohort was not deemed necessary"; 6 of 58 registered studies
Show the evidence
Trial
NCT03292653
terminated; "1st two cohorts provided the required data, therefore 3rd cohort was not deemed necessary"
NCT03315143
terminated; "study terminated due to business decision"
NCT03386344
terminated; "Study terminated prematurely for financial reasons and Covid-19 pandemic."
NCT03521934
terminated; "Study terminated due to business decision"
NCT03760965
terminated; "Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies."
NCT03761134
terminated; "Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Sotagliflozin used 300 mg LX4211 (150 mg tablets) — over how long?
9 recorded entries; human; also "300 mg LX4211 (50 mg tablets)", "300 mg LX4211 (liquid)", "400 mg LX4211"
Show the evidence
human
NCT01188863
300 mg LX4211 (150 mg tablets)
NCT01188863
300 mg LX4211 (50 mg tablets)
NCT01188863
300 mg LX4211 (liquid)
NCT01292993
400 mg LX4211
NCT01376557
75 mg LX4211
NCT01376557
200 mg LX4211
3 more recorded rows
humanNCT01913002
LX4211 800 mg
humanNCT01913002
LX4211 2000 mg
humanNCT01916850
LX4211 400 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Sotagliflozin's half-life is 21 to 35 hours — which schedules were studied?
21 to 35 hours, the half-life Sotagliflozin's label states. openfda-label · 1a46614e-05f6-421a-b6f4-d6f8760d643a · 2026-08-30
bioavailability 25% %.
Show the evidence
half life
21 to 35 hours hours; Following administration of 200 mg and 400 mg, mean terminal half-life (T 1/2 ) ranged from 21 to 35 hours for sotagliflozin and from 19 to 26 hours for sotagliflozin 3-O-glucuronide.
bioavailability
25% %; Absorption The absolute bioavailability of oral sotagliflozin 400 mg dose was approximately 25% (90% confidence interval [CI] 16% to 39%) for area under the concentration-time curve from time 0 to last measurable concentration (AUC 0-last ).
metabolism
The mean apparent volume of distribution of sotagliflozin following administration of a single 400 mg oral dose of [ 14 C]-sotagliflozin was 9000 L. Elimination Metabolism Following the administration of a single dose of 400 mg [ 14 C]-sotagliflozin in healthy subjects, sotagliflozin was extensively metabolized predominantly to sotagliflozin 3-O-glucuronide and it represented 94.3% of the…
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Sotagliflozin's effect on maximum observed plasma concentration?
Maximum observed plasma concentration: measured in Sotagliflozin's trials.
Interpretation maximum observed plasma concentration is the recorded endpoint.
Show the evidence
biomarkers
maximum observed plasma concentration; 2026-09-01
gut hormones; 2026-09-01
postprandial glucose; 2026-09-01
qtc intervals; 2026-09-01
adverse events; 2026-09-01
rate of glucose appearance after meal; 2026-09-01
14 more recorded rows
biomarkers
urinary glucose excretion; 2026-09-01
biomarkers
hemoglobin a1c at week 12; 2026-09-01
biomarkers
a1c at week 24; 2026-09-01
biomarkers
treatment emergent adverse events; 2026-09-01
biomarkers
hemoglobin a1c at week 26; 2026-09-01
biomarkers
assessment of midazolam pk parameter auc; 2026-09-01
biomarkers
assessment of metoprolol pk parameter auc; 2026-09-01
biomarkers
maximum plasma concentration; 2026-09-01
biomarkers
area under the concentration time curve from 0 to infinity; 2026-09-01
biomarkers
hba1c at week 26; 2026-09-01
biomarkers
hemoglobin a1c at week 18; 2026-09-01
biomarkers
hemoglobin a1c at week 52; 2026-09-01
biomarkers
assessment of pk parameter auctau; 2026-09-01
biomarkers
assessment of pharmacodynamic parameters in feces; 2026-09-01
half life
2026-09-04; halfLife; hours; 21 to 35 hours; 2026-08-30
human trials at or under30
19
smallest human trial
6; NCT03802487; PHASE1; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED
Q7
Which of a1c at week 24, adverse events and area under the concentration time curve from 0 to infinity did Sotagliflozin's trials measure?
a1c at week 24, adverse events and area under the concentration time curve from 0 to infinity lead 36 outcome terms across Sotagliflozin's trials. ClinicalTrials.gov · 2026-09-01
qtc intervals, adverse events, rate of glucose appearance after meal, urinary glucose excretion, hemoglobin a1c at week 12 and a1c at week 24 follow.
Show the evidence
maximum observed plasma concentration
1
gut hormones
1
postprandial glucose
1
qtc intervals
1
adverse events
1
rate of glucose appearance after meal
1
14 more recorded rows
urinary glucose excretion
1
hemoglobin a1c at week 12
1
a1c at week 24
1
treatment emergent adverse events
1
hemoglobin a1c at week 26
1
assessment of midazolam pk parameter auc
1
assessment of metoprolol pk parameter auc
1
maximum plasma concentration
1
area under the concentration time curve from 0 to infinity
1
hba1c at week 26
1
hemoglobin a1c at week 18
1
hemoglobin a1c at week 52
1
assessment of pk parameter auctau
1
assessment of pharmacodynamic parameters in feces
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Sotagliflozin's 12 ongoing trials reports first?
"Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes"; n 24; "Change in HbA1c"; 2028-01
NCT06082063
"Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes"; n 2000; "MACE + HHF"; 2029-07-01
NCT06147232
"Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia"; n 69; "Change in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation"; 2027-05
NCT06217302
"Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease"; n 150; "eGFR at the end of the wash-out period following the treatment period"; 2029-05
NCT06433050
"Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy"; n 26; "Number of participants with treatment-related adverse events"; 2027-06
NCT06435156
"Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes"; n 320; "Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score"; 2027-10-31
6 further recorded trials
NCT06481891
"A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy"; n 500; "Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS)"; 2027-02
NCT06510894
"Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression"; n 40; "Complete myocardial glucose suppression"; 2027-12-31
NCT07421518
"Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors"; n 75; "Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L"; 2030-04
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
NCT07572175
"Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity"; n 60; "Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI"; 2029-10
NCT07594145
"Precision T1D Platform - New Therapies for Cardio-Renal Complications"; n 57; "Markers of Renal Health [Safety and Tolerability]"; 2031-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 13 trials of Sotagliflozin posted no result?
Posted no result
13 of 13 completed trials
Registrations
NCT02940379, NCT03070678, NCT03063580, NCT03211195, NCT02647918 and NCT03174548, and 7 more
Completion dates
oldest 2016-12; newest 2019-08-19
Show the evidence
Trial
NCT02940379
2016-12
NCT03070678
2017-04-18
NCT03063580
2017-05-12
NCT03211195
2017-08-22
NCT02647918
2017-09
NCT03174548
2017-09-15
7 further recorded trials
NCT03310944
2017-12-08
NCT03387657
2018-03-02
NCT03414723
2018-03-10
NCT03802487
2019-03-28
NCT03462069
2019-04-18
NCT03776227
2019-04-22
NCT03909451
2019-08-19
Q10
At the median, Sotagliflozin's trials enrolled 63.5 people — anything larger?
Median enrolment
63.5
Largest enrolment
10584
Registered trials counted
58
Q11
What do 5 spontaneous reports say about Sotagliflozin — 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.
Sotagliflozin appears in spontaneous reports to regulators. Across the 1 most-reported reaction term, 5 reaction mentions were counted: hypoglycaemia 5. open-targets-adr · CHEMBL3039507 · 2026-06-24
Show the evidence
hypoglycaemia
5
recorded 2026-06-24 · last checked 2026-09-04
Q12
Sotagliflozin and CYP3A4, BCRP and CYP2D6: shared by which compounds?
CYP3A4, BCRP and CYP2D6 appear in Sotagliflozin's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2D6
pharmacokinetics
Drug Interactions In Vitro Studies The major human metabolite of sotagliflozin, sotagliflozin 3-O-glucuronide, was shown to have an in vitro potential to inhibit CYP3A4 and CYP2D6 and to induce CYP3A4.
pharmacokinetics
The increases in exposure (AUC) of metoprolol (CYP2D6 substrate) and rosuvastatin (BCRP substrate), as well as the decrease in exposure to midazolam (CYP3A4 substrate) are not considered to be clinically relevant.
CYP3A4
pharmacokinetics
The key enzymes responsible for the metabolism of sotagliflozin were UGT1A9 and, to a lesser extent, CYP3A4.
pharmacokinetics
Drug Interactions In Vitro Studies The major human metabolite of sotagliflozin, sotagliflozin 3-O-glucuronide, was shown to have an in vitro potential to inhibit CYP3A4 and CYP2D6 and to induce CYP3A4.
pharmacokinetics
The increases in exposure (AUC) of metoprolol (CYP2D6 substrate) and rosuvastatin (BCRP substrate), as well as the decrease in exposure to midazolam (CYP3A4 substrate) are not considered to be clinically relevant.
recorded 2026-08-30 · last checked 2026-09-04
Q13
Was Sotagliflozin studied with fasting?
fasting is named in Sotagliflozin's label sentences: "At 52 weeks, mean treatment differences between sotagliflozin 400 mg and placebo were -1.08 mmol/L for fasting plasma glucose, -4.32 kg for weight, and -15.63% for bolus insulin dose and -11.87% for basal insulin dose (all <i>P</i> < 0.001)." openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
At 52 weeks, mean treatment differences between sotagliflozin 400 mg and placebo were -1.08 mmol/L for fasting plasma glucose, -4.32 kg for weight, and -15.63% for bolus insulin dose and -11.87% for basal insulin dose (all <i>P</i> < 0.001).
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Sotagliflozin and mTOR?
"Sotagliflozin reduced cell viability, clonogenic survival, migration, and invasion, and these effects were accompanied by G2/M cell-cycle arrest, increased AMPK activation, and changes in PTEN-AKT-mTOR signalling." — where Sotagliflozin and mTOR appear together. Europe PMC · pathway abstract search · 2026-09-01
mTOR, AMPK; PMID 42677956
Show the evidence
mTORPMID 42677956
"Sotagliflozin reduced cell viability, clonogenic survival, migration, and invasion, and these effects were accompanied by G2/M cell-cycle arrest, increased AMPK activation, and changes in PTEN-AKT-mTOR signalling."
AMPKPMID 42677956
"Sotagliflozin reduced cell viability, clonogenic survival, migration, and invasion, and these effects were accompanied by G2/M cell-cycle arrest, increased AMPK activation, and changes in PTEN-AKT-mTOR signalling."
recorded 2026-09-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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