This page shows what was measured, who it was measured in, and what that does not settle.
What Ozanimod does in the body
Ozanimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood.
From the FDA-approved label: Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Ozanimod has minimal or no activity on S1P 2 , S1P 3 , and S1P 4 . The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis and ulcerative colitis is unknown but may involve the reduction of lymphocyte migration into the central nervous system and intestine.
Why people take it. ZEPOSIA is indicated for the treatment of: relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. moderately to severely active ulcerative colitis (UC) in adults.
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 · Z80293URPV · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
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 134 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 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 Participants Experiencing Adverse Events (AEs)
✗ The study did not show it
Who was studied
NCT02576717
How many people
2494
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
Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
✗ The study did not show it
Who was studied
NCT02294058
How many people
1346
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
Adjusted Annualized Relapse Rate (ARR) at the End of Month 24
✗ The study did not show it
Who was studied
NCT02047734
How many people
1320
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 in Clinical Remission at 10 Weeks
✗ The study did not show it
Who was studied
NCT02435992
How many people
1012
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
Time to sustained disability progression
✗ The study did not show it
Who was studied
NCT03500328
How many people
900
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA 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 Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
✗ The study did not show it
Who was studied
NCT02531126
How many people
877
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 eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.2 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.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
maximum plasma concentration
area under the plasma concentration time curve
Meaningful
Things that change how a life goes, not only a number.
clinical remission
annualized relapse rate
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 adverse events
experiencing serious adverse events
experiencing adverse events leading to discontinuation
experiencing adverse events of special interest
treatment emergent adverse events
brain volume loss baseline to month 36
edss+ month 48 to month 108
pharmacokinetics cmax
pharmacokinetics auc
pharmacokinetics auc0 14d
adverse events
cardiovascular
clinical response
pharmacokinetic cmax
pharmacokinetic auc
pharmacokinetic auclast
pharmacokinetic tmax
pharmacokinetic cl/f
pharmacokinetic vz/f
pharmacokinetic t1/2
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 hours hours
Read from the label, which states: “Elimination The mean (CV%) plasma half-life (t1/2) of ozanimod is approximately 21 hours (15%).”
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.
ZEPOSIA is indicated for the treatment of: relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. moderately to severely active ulcerative colitis (UC) in adults.
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 in pediatric patients have not been established.”
US prescribing information · 93ce2fab-edfb-4804-8074-963071de51e4 · read 2026-08-30
On older people, the label states: “Clinical studies of ZEPOSIA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
US prescribing information · 93ce2fab-edfb-4804-8074-963071de51e4 · 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 women exposed to ZEPOSIA during pregnancy.”
US prescribing information · 93ce2fab-edfb-4804-8074-963071de51e4 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of ozanimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
US prescribing information · 93ce2fab-edfb-4804-8074-963071de51e4 · read 2026-08-30
On people with reduced liver function, the label states: “In patients with mild (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B), the exposures of ozanimod and its active metabolites are higher than those in healthy controls [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions.”
US prescribing information · 93ce2fab-edfb-4804-8074-963071de51e4 · 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
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 capsule, 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.
Ozanimod appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 976 reaction mentions were counted. One report can name several reactions.
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
15 products list this as an active ingredient in the United States drug directory. 15 of them contain it and nothing else.
FDA National Drug Code directory · 47848-061 · read 2026-08-29
They are sold as capsule and powder, taken oral.
FDA National Drug Code directory · 47848-061 · 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 · 47848-061 · 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 · 93ce2fab-edfb-4804-8074-963071de51e4 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 93ce2fab-edfb-4804-8074-963071de51e4 · read 2026-08-29
ZEPOSIA 7-Day Starter Pack is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: 0.23 mg ozanimod: light grey opaque body/light grey opaque cap imprinted with black ink "OZA" on the cap and "0.23 mg" on the body 0.46 mg ozanimod: light grey opaque body/orange o…, recorded as fda label in effect 2026-04-16 in the United States.
US prescribing information · 93ce2fab-edfb-4804-8074-963071de51e4 · 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.
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 Ozanimod 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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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 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 Ozanimod 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)
Z80293URPV
CAS registry number
1306760-87-1
PubChem compound
52938427
WHO international nonproprietary name list entry
10057
RxNorm concept
2288236
EMA substance identifier
100000167014
DrugBank
DB12612
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 unclear◇Read 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
3 approved applications cover products containing this substance. The earliest was NDA209899, approved 20200325 to BRISTOL.
This order is fixed in code and does not count clicks or time on the page.
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.
What was measured, goal by goal — 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 (12)
Q2
What did Ozanimod's largest trial (4000 people) and its longest (15 years) measure?
4000 people in Ozanimod's largest registered study, 15 years in its longest registered window, measuring Maximum plasma concentration (Cmax). ClinicalTrials.gov · 2026-09-01
16 phase3, 15 na or unstated, 11 phase1, 7 phase2, 7 phase4; NCT07732907; 2041-07-31; no ageing endpoint recorded. Last human test completed 2025, NCT03915769.
Interpretation These counts include studies where Ozanimod 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
16
na or unstated
15
phase1
11
phase2
7
phase4
7
Last recorded human testNCT03915769
2025-09-30
recorded 2026-09-01 · last checked 2026-09-04
Q3
Ozanimod was tested only in human — what did it show?
safety (1), accrual/recruitment (1), funding/business (10), sponsor decision unspecified (1) and other (1): Ozanimod's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Business objectives have changed."; 14 of 53 registered studies
Show the evidence
Trial
NCT03440372
terminated; "Business objectives have changed."
NCT03464097
terminated; "The study has terminated due to non-safety reasons; Business Objectives have changed."
NCT03467958
terminated; "Business objectives have changed"
NCT04140305
terminated; "Business objective has changed"
NCT04405102
terminated; "Screening was stopped by the Sponsor (43/48 participants enrolled), given the very low number of eligible patients (high vaccination rate and occurrence of the Omicron variant). The last patient randomized performed his follow-up visit."
NCT05319093
terminated; "Funding ended prematurely"
8 further recorded trials
NCT05369832
terminated; "Business objectives have changed."
NCT05382715
terminated; "Business objectives have changed"
NCT05470985
terminated; "Study was terminated due to business reasons."
NCT05644665
terminated; "Business objectives have changed"
NCT05777902
terminated; "Sponsor's decision"
NCT05809583
withdrawn; "Funding withdrawn"
NCT06188637
withdrawn; "Funder decision"
NCT06334094
withdrawn; "The funding for the study was revoked. As such, the study is no longer being conducted."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Ozanimod's half-life is 21 hours — which schedules were studied?
21 hours, the half-life Ozanimod's label states. openfda-label · 93ce2fab-edfb-4804-8074-963071de51e4 · 2026-08-30
Show the evidence
half life
21 hours hours; Elimination The mean (CV%) plasma half-life (t1/2) of ozanimod is approximately 21 hours (15%).
tmax
Parameters Ozanimod CC112273 C max,ss 0.244 ng/mL (31.8%) 6.98 ng/mL (42.7%) AUC tau,ss 4.46 ng*h/mL (31.8%) 143.77 ng*h/mL (39.2%) Dose Proportionality The C max and AUC increases proportionally over the ozanimod dose range from 0.46 mg to 0.92 mg. Time to Steady State 102 hours (28.2%) b 45 days (45%) Accumulation Ratio 2.40 (21.1%) b 16 (101%) Absorption The T max of ozanimod is approximately…
metabolism
Metabolism Ozanimod is metabolized by multiple enzymes to form circulating major active metabolites (e.g., CC112273 and CC1084037) and minor active metabolites (e.g., RP101988, RP101075, and RP112509) with similar activity and selectivity for S1P 1 and S1P 5 .
recorded 2026-08-30 · last checked 2026-09-04
Q6
Which of adverse events, annualized relapse rate and area under the plasma concentration time curve did Ozanimod's trials measure?
adverse events, annualized relapse rate and area under the plasma concentration time curve lead 29 outcome terms across Ozanimod's trials. ClinicalTrials.gov · 2026-09-01
experiencing adverse events of special interest, maximum plasma concentration, area under the plasma concentration time curve, clinical remission, treatment emergent adverse events and brain volume loss baseline to month 36 follow.
Show the evidence
experiencing adverse events
1
experiencing serious adverse events
1
experiencing adverse events leading to discontinuation
1
experiencing adverse events of special interest
1
maximum plasma concentration
1
area under the plasma concentration time curve
1
14 more recorded rows
clinical remission
1
treatment emergent adverse events
1
brain volume loss baseline to month 36
1
edss+ month 48 to month 108
1
pharmacokinetics cmax
1
pharmacokinetics auc
1
pharmacokinetics auc0 14d
1
adverse events
1
cardiovascular
1
clinical response
1
pharmacokinetic cmax
1
pharmacokinetic auc
1
pharmacokinetic auclast
1
pharmacokinetic tmax
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Ozanimod's 13 ongoing trials reports first?
Brain volume loss, baseline to month 36; Proportion of participants who achieve clinical remission; latest 2041-07-31
Show the evidence
Trial
NCT03535298
"Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS"; n 800; "Brain volume loss, baseline to month 36"; 2027-07-30
NCT05076175
"A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis"; n 120; "Proportion of participants who achieve clinical remission"; 2032-07-12
NCT05688436
"A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies"; n 1178; "Number of Major Congenital Malformations (MCMs)"; 2031-01-17
NCT06073873
"A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea"; n 3000; "Adverse events"; 2028-04-01
NCT06126835
"A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants"; n 2828; "Prevalence of major congenital malformations among infants"; 2032-06-30
NCT06133049
"A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants"; n 2961; "Prevalence of major congenital malformations among infants"; 2031-08-31
7 further recorded trials
NCT06396039
"A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis"; n 84; "Annualized relapse rate (ARR) over 36 months"; 2029-03-30
NCT06408259
"Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis"; n 194; "Annualized relapse rate (ARR)"; 2036-07-13
NCT06529406
"Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod"; n 100; "New T2 lesions count"; 2029-08-01
NCT06862960
"Ozanimod in Patients With Alzheimer's Disease"; n 40; "Mean Absolute Change From Baseline in Brain Amyloid Plaque on 18F-florbetaben PET Scan on Ozanimod Group Versus Control Group"; 2027-12-30
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
NCT07271069
"Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis"; n 150; "Proportion of participants achieving steroid-free symptomatic remission"; 2027-12-31
NCT07732907
"Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia"; n 15; "Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis"; 2041-07-31
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Ozanimod 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
TrialNCT07177209
"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
Q9
Which 12 trials of Ozanimod posted no result?
Posted no result
12 of 12 completed trials
Registrations
NCT02994381, NCT02797015, NCT03624959, NCT03644576, NCT03694119 and NCT03665610, and 6 more
Completion dates
oldest 2016-11; newest 2023-02-26
Show the evidence
Trial
NCT02994381
2016-11
NCT02797015
2017-10-20
NCT03624959
2018-08-10
NCT03644576
2018-09-12
NCT03694119
2019-01-08
NCT03665610
2019-01-10
6 further recorded trials
NCT04149678
2019-12-26
NCT04211558
2020-10-09
NCT04528290
2021-06-01
NCT05001152
2021-09-27
NCT04639115
2022-04-06
NCT04978298
2023-02-26
Q10
At the median, Ozanimod's trials enrolled 139 people — anything larger?
Median enrolment
139
Largest enrolment
4000
Registered trials counted
53
Q11
What do 976 spontaneous reports say about Ozanimod — 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.
Ozanimod appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 976 reaction mentions were counted: fatigue 231; headache 155; dizziness 115; multiple sclerosis relapse 110. open-targets-adr · CHEMBL3707246 · 2026-06-24
Show the evidence
fatigue
231
headache
155
dizziness
115
multiple sclerosis relapse
110
back pain
80
fall
71
4 more recorded rows
product dose omission issue
58
hypoaesthesia
57
weight decreased
55
blood pressure increased
44
recorded 2026-06-24 · last checked 2026-09-04
Q12
Ozanimod and CYP2C8, P-GP and BCRP: shared by which compounds?
CYP2C8, P-GP and BCRP appear in Ozanimod's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2C8
pharmacokinetics
CC112273 is then metabolized by CYP2C8 to form RP112509 or reduced to form CC1084037.
pharmacokinetics
Strong CYP2C8 Inhibitors Co-administration of ozanimod with gemfibrozil (a strong CYP2C8 inhibitor) increased exposure (AUC) of active metabolites CC112273 and CC1084037 by approximately 47% and 69%, respectively, with no change in the AUC of ozanimod [see Drug Interactions (7) ].
pharmacokinetics
Strong CYP2C8 Inducers Co-administration of rifampin (a strong inducer of CYP3A and P-gp, and a moderate inducer of CYP2C8) 600 mg once daily at steady state and a single dose of ZEPOSIA 0.92 mg reduced the exposure (AUC) for ozanimod, CC112273, and CC1084037 by approximately 24%, 60%, and 55%, respectively.
pharmacokinetics
The effect on CC112273 and CC1084037 is primarily caused by induction of CYP2C8 [see Drug Interactions (7) ].
CYP3A4pharmacokinetics
Ozanimod is metabolized by ALDH/ADH to form carboxylate metabolite RP101988 and by CYP3A4 to form RP101075.
recorded 2026-08-30 · last checked 2026-09-04
Q13
What is recorded about Ozanimod and mTOR?
"Sirolimus (a highly specific inhibitor of the 'molecular target of rapamycin', mTOR) and ozanimod (an agonist of the sphingosine 1-phosphate receptor, recently approved for treatment of multiple sclerosis and ulcerative colitis) are used for this purpose." — where Ozanimod and mTOR appear together. Europe PMC · pathway abstract search · 2022-07-01
mTOR; PMID 36042174
Show the evidence
mTOR
PMID 36042174
"Sirolimus (a highly specific inhibitor of the 'molecular target of rapamycin', mTOR) and ozanimod (an agonist of the sphingosine 1-phosphate receptor, recently approved for treatment of multiple sclerosis and ulcerative colitis) are used for this purpose."
"Sirolimus (a highly specific inhibitor of the ‘molecular target of rapamycin’, mTOR) and ozanimod (an agonist of the sphingosine 1-phosphate receptor, a recently approved drug for treatment of multiple sclerosis and ulcerative colitis) are used for this purpose."
"Sirolimus (a highly specific inhibitor of the ‘molecular target of rapamycin’, mTOR) and ozanimod (an agonist of the sphingosine 1-phosphate receptor, a recently approved drug for treatment of multiple sclerosis and ulcerative colitis) were investigated for this purpose."
recorded 2022-07-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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