Etrasimod
- 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 Etrasimod does in the body
Etrasimod partially and reversibly blocks the capacity of lymphocytes to egress from lymphoid organs, reducing the number of lymphocytes in peripheral blood.
From the FDA-approved label: Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1, 4, and 5 (S1P 1,4,5 ). The mechanism by which etrasimod exerts therapeutic effects in UC is unknown but may involve the reduction of lymphocyte migration into the intestines.
Why people take it. Moderately to severely active ulcerative colitis
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. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · MXE5EMA09L · read 2026-08-29
Its recorded molecular formula is C32H40F3N5O5, weighing 631.69 g/mol.
US prescribing information · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · 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 90 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.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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.
- Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. No reviewed result.
- What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
- Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
- Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
- A number that stands in for health No evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
- 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.
- Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
- 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.
- 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.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
- achieving clinical remission at week 52
- achieving clinical remission
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 (1)
- 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 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.
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. 30 hours hours
Read from the label, which states: “Elimination The mean plasma elimination half-life (t 1/2 ) of etrasimod is approximately 30 hours with an apparent steady-state oral clearance of approximately 1 L/h after oral administration.”
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 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.
- VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. VELSIPITY is a sphingosine 1-phosphate receptor modulator indicated for the treatment of moderately to severely active ulcerative colitis in adults. ( 1 )
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 VELSIPITY in pediatric patients have not been established.”
US prescribing information · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · read 2026-08-30
On older people, the label states: “Clinical studies of VELSIPITY did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger adult subjects.”
US prescribing information · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to VELSIPITY during pregnancy.”
US prescribing information · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of etrasimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
US prescribing information · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · read 2026-08-30
On people with reduced liver function, the label states: “Etrasimod undergoes extensive hepatic metabolism .”
US prescribing information · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · 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.
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
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.
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 takeRead from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
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. A regulator classifies this substance in a way that restricts how it is supplied.
Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3.
No source is stored against this line.
What is in the pack
Sold as tablet, 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.
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
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 · 0069-0274 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 0069-0274 · read 2026-08-29
The regulator's established pharmacologic class for it is sphingosine 1-phosphate receptor modulators [moa] and sphingosine 1-phosphate receptor modulator [epc].
FDA National Drug Code directory · 0069-0274 · 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 · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · read 2026-08-29
3897 marketed supplement labels list this ingredient, classed as amino acid/protein and other combinations.
NIH Dietary Supplement Label Database · 177918 · read 2026-08-29
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
NIH Dietary Supplement Label Database · 177918 · read 2026-08-29
Velsipity is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 2 mg of etrasimod as a round, green, film-coated tablet, debossed with “ETR” on one side and “2” on the other side., recorded as fda label in effect 2025-08-18 in the United States.
US prescribing information · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · 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 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. The questions below are for a clinician or pharmacist.
Questions worth asking
- Which of the trials of Etrasimod 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 Etrasimod 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)
- MXE5EMA09L
- CAS registry number
- 1206123-97-8
- PubChem compound
- 44624336
- EMA substance identifier
- 300000044580
Checks this page had to pass
Passed
Identity resolved
no open identity hold
Passed
No unresolved merge across substance families
no quarantine open
Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
Passed
Safety mode resolved
Suppression classes recorded: S1, S3.
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
1 approved application covers products containing this substance. The earliest was NDA216956, approved 20231012 to PFIZER.
Drugs@FDA application register · NDA216956 · read 2026-08-29
Marketing status on the register: prescription.
Drugs@FDA application register · NDA216956 · read 2026-08-29
The earliest marketing start date recorded for a listed product is 20220930.
FDA National Drug Code directory · 0069-0274 · 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.
- Were people like me actually studied?
- How close is this evidence to something I would notice?
- What does nobody know about this yet?
- What is a biomarker?
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 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.
- What was measured, goal by goal — found nothing in the sources checked.
- What happened in people — found nothing in the sources checked.
- The path through the body — found nothing in the sources checked.
- What it may clash with — found nothing in the sources checked.
- Other ways to the same goal — found nothing in the sources checked.
- Claims that go past the evidence — found nothing in the sources checked.
- What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (10)
What did Etrasimod's largest trial (4000 people) and its longest (11 years) measure?
4000 people in Etrasimod's largest registered study, 11 years in its longest registered window, measuring Change in Serum Alkaline Phosphatase (ALP) Concentration. ClinicalTrials.gov · 2026-09-01
16 phase2, 7 phase3, 6 na or unstated, 1 phase1, 1 phase4; NCT05287126; 2033-07-10; no ageing endpoint recorded. Last human test completed 2024, NCT04607837.
Interpretation These counts include studies where Etrasimod 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
- phase216
- phase37
- na or unstated6
- phase11
- phase41
- Last recorded human test NCT046078372024-06-19
recorded 2026-09-01 · last checked 2026-09-04
Etrasimod was tested only in human — what did it show?
human: biomarker (29): the rungs where Etrasimod has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01
Interpretation Change in Serum Alkaline Phosphatase (ALP) Concentration — the recorded outcome words.
Show the evidence
- human NCT03155932biomarker; Change in Serum Alkaline Phosphatase (ALP) Concentration; 29
recorded 2026-09-01 · last checked 2026-09-04
6 of Etrasimod's trials stopped: safety, futility/efficacy, accrual/recruitment, sponsor decision unspecified?
safety (1), futility/efficacy (1), accrual/recruitment (1) and sponsor decision unspecified (3): Etrasimod's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Terminated \[Sponsor decision to terminate the study\]"; 6 of 29 registered studies
Show the evidence
Trial
- NCT03072953terminated; "Terminated \[Sponsor decision to terminate the study\]"
- NCT03139032terminated; "Sponsor decision to terminate the study"
- NCT03155932terminated; "Sponsor decision"
- NCT04173273terminated; "The study was prematurely discontinued due to a lack of efficacy in sub-study 1"
- NCT05732454terminated; "Per the results of the planned interim analysis, the study met futility criteria for efficacy so the trial was terminated. This decision was made for efficacy reasons only and is not due to any safety concerns."
- NCT06521762withdrawn; "The study was terminated early as no patients were enrolled."
recorded 2026-09-01 · last checked 2026-09-04
Human studies of Etrasimod used Etrasimod 1 mg — over how long?
studies of Etrasimod used the recorded amount. ClinicalTrials.gov · 2026-09-01
2 recorded entries; human; also "Etrasimod 1 mg", "Etrasimod 2 mg"
Show the evidence
human
- NCT04162769Etrasimod 1 mg
- NCT04162769Etrasimod 2 mg
recorded 2026-09-01 · last checked 2026-09-04
Etrasimod's half-life is 30 hours — which schedules were studied?
30 hours, the half-life Etrasimod's label states. openfda-label · 65171e4a-d136-4abc-b08c-c40c1b486ff6 · 2026-08-30
Show the evidence
- half life30 hours hours; Elimination The mean plasma elimination half-life (t 1/2 ) of etrasimod is approximately 30 hours with an apparent steady-state oral clearance of approximately 1 L/h after oral administration.
- tmaxAbsorption The median (range) time to reach etrasimod C max (T max ) is approximately 4 hours (range 2 to 8 hours) after oral administration.
- metabolismMetabolism Etrasimod is metabolized by oxidation and dehydrogenation mediated primarily by CYP2C8, CYP2C9, and CYP3A4, with a minor contribution by CYP2C19 and CYP2J2.
recorded 2026-08-30 · last checked 2026-09-04
Which of achieving clinical remission, achieving clinical remission at week 52 and adverse events did Etrasimod's trials measure?
achieving clinical remission, achieving clinical remission at week 52 and adverse events lead 3 outcome terms across Etrasimod's trials. ClinicalTrials.gov · 2026-09-01
3 terms in all.
Show the evidence
- adverse events1
- achieving clinical remission at week 521
- achieving clinical remission1
recorded 2026-09-01 · last checked 2026-09-04
Which of Etrasimod's 12 ongoing trials reports first?
12 registered trials of Etrasimod are open; earliest completion 2026-07-31. ClinicalTrials.gov · 2026-09-01
Number and Severity of Safety Measures; Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52; latest 2034-08-18
Show the evidence
Trial
- NCT03950232"An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis"; n 896; "Number and Severity of Safety Measures"; 2029-06-19
- NCT05287126"A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis"; n 36; "Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52"; 2033-07-10
- NCT06025227"Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients."
- NCT06294925"A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis"; n 360; "Proportion of patients with symptomatic remission"; 2027-05-13
- NCT06398626"An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis"; n 300; "Proportion of patients with symptomatic remission"; 2028-07-07
- NCT07153159"A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women"; n 8; "Area under the etrasimod concentration-time curve in breast milk"; 2026-10-12
6 further recorded trials
- NCT07177209"Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"; n 4000; "Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis."; 2026-07-31
- NCT07459686"An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis"; n 553; "The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions)"; 2029-01-29
- NCT07470879"A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis"; n 24; "Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52"; 2034-08-18
- NCT07486921"Etrasimod as Prevention of Pouchitis"; n 40; "Proportion of participants with at least 1 episode of acute pouchitis"; 2030-02-06
- NCT07705126"A National Multicenter Study of Etrasimod for the Treatment of Patients With Active UC"; n 500; "Baseline Demographic and Clinical Characteristics of Chinese Adults with Active UC Receiving Etrasimod"; 2028-06-30
- NCT07782242"Comaprison of Efficacy and Safety Between Etrasimod vs Mesalazine in Chinese Adults With Active UC"; n 320; "Percentage of participants achieving clinical remission"; 2027-12-31
recorded 2026-09-01 · last checked 2026-09-04
Which running trial of Etrasimod could settle inflammatory markers?
NCT07177209 measures Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis., reading out 2026-07-31.
1 open trial; n 4000; "Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"
Show the evidence
- Trial NCT07177209"Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"; n 4000; "Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis."; 2026-07-31
At the median, Etrasimod's trials enrolled 129 people — anything larger?
- Median enrolment
- 129
- Largest enrolment
- 4000
- Registered trials counted
- 28
Etrasimod and CYP2C9, CYP2C8 and CYP3A4: shared by which compounds?
CYP2C9, CYP2C8 and CYP3A4 appear in Etrasimod's recorded interaction sentences, 28 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics, clinical_pharmacology
Show the evidence
- CYP1A2 pharmacokineticsIn Vitro Studies Based on in vitro studies, etrasimod is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4, nor an inducer of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations.
- CYP2B6 pharmacokineticsIn Vitro Studies Based on in vitro studies, etrasimod is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4, nor an inducer of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations.
CYP2C19
- pharmacokineticsMetabolism Etrasimod is metabolized by oxidation and dehydrogenation mediated primarily by CYP2C8, CYP2C9, and CYP3A4, with a minor contribution by CYP2C19 and CYP2J2.
- pharmacokineticsIn Vitro Studies Based on in vitro studies, etrasimod is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4, nor an inducer of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations.
CYP2C8
- pharmacokineticsMetabolism Etrasimod is metabolized by oxidation and dehydrogenation mediated primarily by CYP2C8, CYP2C9, and CYP3A4, with a minor contribution by CYP2C19 and CYP2J2.
- pharmacokineticsIn Vitro Studies Based on in vitro studies, etrasimod is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4, nor an inducer of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations.
- clinical_pharmacologyCYP2C9 intermediate metabolizers (e.g., *1/*2, *1/*3, *2/*2) may have decreased clearance of etrasimod when VELSIPITY is used concomitantly with moderate to strong inhibitors of CYP2C8 or CYP3A4; however, the effect on VELSIPITY exposure in CYP2C9 intermediate metabolizers with concomitant CYP2C8 or CYP3A4 inhibitors is not known.
- pharmacokineticsCombined CYP3A4 (strong), CYP2C8 (moderate) and CYP2C9 (moderate) inducers: Concomitant use of etrasimod with rifampin (strong CYP3A4, moderate CYP2C8, and CYP2C9 inducer) decreased etrasimod AUC by 49% [see Drug Interactions (7) ].
- pharmacokineticsGemfibrozil (an inhibitor of OATP1B1 and OAT3 and a strong inhibitor of CYP2C8) increased etrasimod AUC by 36%.
- clinical_pharmacologyCYP2C9 poor metabolizers (e.g., *2/*3, *3/*3) may have decreased clearance of etrasimod when VELSIPITY is used concomitantly with moderate to strong inhibitors of CYP2C8 or CYP3A4 [see Drug Interactions (7) and Use in Specific Populations (8.7) ] .
CYP2C9
- pharmacokineticsMetabolism Etrasimod is metabolized by oxidation and dehydrogenation mediated primarily by CYP2C8, CYP2C9, and CYP3A4, with a minor contribution by CYP2C19 and CYP2J2.
- pharmacokineticsIn Vitro Studies Based on in vitro studies, etrasimod is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4, nor an inducer of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations.
- clinical_pharmacologyEtrasimod is not a substrate or an inhibitor of P-gp, BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, and MATE2-K transporters. 12.5 Pharmacogenomics CYP2C9 activity is decreased in individuals with genetic variants such as CYP2C9*2 and CYP2C9*3 alleles.
- clinical_pharmacologyThe impact of CYP2C9 genetic variants on the pharmacokinetics of etrasimod has not been directly evaluated.
- clinical_pharmacologyCYP2C9 intermediate metabolizers (e.g., *1/*2, *1/*3, *2/*2) may have decreased clearance of etrasimod when VELSIPITY is used concomitantly with moderate to strong inhibitors of CYP2C8 or CYP3A4; however, the effect on VELSIPITY exposure in CYP2C9 intermediate metabolizers with concomitant CYP2C8 or CYP3A4 inhibitors is not known.
- clinical_pharmacologyThe prevalence of the CYP2C9 poor metabolizer phenotype is approximately 2 to 3% in White populations, 0.5 to 4% in Asian populations, and <1% in African-American populations.
4 more recorded rows
- CYP2C9 clinical_pharmacologyOther decreased or nonfunctional CYP2C9 alleles (e.g., *5, *6, *8, *11) are more prevalent in African-American populations.
- CYP2C9 pharmacokineticsCombined CYP3A4 (strong), CYP2C8 (moderate) and CYP2C9 (moderate) inducers: Concomitant use of etrasimod with rifampin (strong CYP3A4, moderate CYP2C8, and CYP2C9 inducer) decreased etrasimod AUC by 49% [see Drug Interactions (7) ].
- CYP2C9 pharmacokineticsDrug Interaction Studies Clinical Studies Combined moderate CYP2C9 and CYP3A4 inhibitors: Concomitant use of etrasimod with steady-state fluconazole (moderate CYP2C9 and CYP3A4 inhibitor) increased etrasimod AUC by 84% [see Drug Interactions (7) ] .
- CYP2C9 clinical_pharmacologyCYP2C9 poor metabolizers (e.g., *2/*3, *3/*3) may have decreased clearance of etrasimod when VELSIPITY is used concomitantly with moderate to strong inhibitors of CYP2C8 or CYP3A4 [see Drug Interactions (7) and Use in Specific Populations (8.7) ] .
recorded 2026-08-30 · last checked 2026-09-04
Where it is registered
Identifiers, relations and other names
The exact record
- UNII
- MXE5EMA09L
- ChEMBL id
- CHEMBL3358920
- PubChem CID
- 44624067
- CAS number
- 1206123-51-4
- InChIKey
- MVGWUTBTXDYMND-QGZVFWFLSA-N
- Development code
- APD-334, APD334 L-Arginine, APD-334 L-ARGININE
- Also called
- Apd334, ETRASIMOD ARGININE, Etrasimod Arginine [USAN], Etrasimod arginine [MI], Etrasimod arginine [WHO-DD]
- Trade name
- Velsipity
Sources (7)
Sources
- ClinicalTrials.gov clinicaltrials.gov ·
- ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
- this record's own fields 2,3,5 ·
- Europe PMC and ClinicalTrials.gov organism ladder ·
- openfda-label 65171e4a-d136-4abc-b08c-c40c1b486ff6 ·
- openfda-label+europepmc K1:6WH8495MMH ·
1 more source
- national registers US, EU, CA ·
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · 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: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
- public claims reviewed: 0 reviewed claim(s); drafts are never rendered
- source coverage passed: 7 source rows
- no critical contamination: no quarantine open
- canonical metadata passed: slug and display name present
- no raw internal fields: enforced by the copy-contract test over the rendered page
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