Ozanimod
How it works: Keeping immune cells out of the brain →
Zeposia
EU: Approved in the EU since 2020US: FDA approved 2020
- Other names
- ozanimod hydrochloride
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Sphingosine 1-phosphate receptor 5 modulator
- Targets
- Sphingosine 1-phosphate receptor 5
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
Safety communications
None recorded.
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
8,608 reports in total, 2,494 marked serious.
- Fatigue774
- Multiple sclerosis relapse592
- Drug ineffective557
- Headache524
- Product dose omission issue370
- Dizziness353
- Nausea289
- Colitis ulcerative269
- Diarrhoea268
- Pain255
Trials
Key trials
Large trials with a reported result on their main goal.
- SUNBEAM
Completed · Phase 3 · Relapsing MS · Main goal met
- RADIANCE
Completed · Phase 3 · Relapsing MS · Main goal met
- RADIANCE
Completed · Phase 2 / Phase 3 · Relapsing MS · Main goal met
Running now
- Ozanimod
Recruiting · MS (type not specified) · ongoing
- IM047-050
Recruiting · Phase 3 · Relapsing MS · ongoing
- COAST
Recruiting · Phase 4 · Relapsing MS · ongoing
- Ozanimod, phase 4
Running, not recruiting · Phase 4 · Relapsing MS · ongoing
- Ozanimod, phase 4
Recruiting · Phase 4 · Relapsing MS · ongoing
- Ozanimod, phase 4
Recruiting · Phase 4 · Relapsing MS · ongoing
- Alemtuzumab
Running, not recruiting · Relapsing MS · ongoing
- Ozanimod
Running, not recruiting · MS (type not specified) · ongoing
Other trials (12)
Completed small trials, dose-finding studies and trials in other diseases.
- Ozanimod, phase 4
Withdrawn · Phase 4 · Relapsing MS · stopped_other
- OMNIAOMS
Terminated · Phase 4 · Relapsing MS · stopped_other
- Ozanimod, phase 4
Moved to EU CTIS registry · Phase 4 · Relapsing MS
- Ozanimod, phase 4
Terminated · Phase 4 · Relapsing MS
- Ozanimod, phase 4
Moved to EU CTIS registry · Phase 4 · Relapsing MS
- Ozanimod
Terminated · MS (type not specified) · stopped_other
- Ozanimod
Status unknown · Relapsing MS · no_result_found
- OzEAN
Completed · Relapsing MS · no_result_found
- STATURE
Status unknown · MS (type not specified) · no_result_found
- ENLIGHTEN
Terminated · Phase 3 · Relapsing MS · stopped_other
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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