Last reviewed · How we verify
Zeposia (OZANIMOD)
Zeposia works by binding to the sphingosine 1-phosphate receptor 1, which helps to reduce inflammation and slow disease progression.
At a glance
| Generic name | OZANIMOD |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Sphingosine 1-phosphate Receptor Modulator |
| Target | Sphingosine 1-phosphate receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2020 |
| Annual revenue | 800 |
Mechanism of action
Ozanimod is sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors and 5. Ozanimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. Ozanimod has minimal or no activity on S1P2, S1P3, and S1P4. 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.
Approved indications
- Multiple sclerosis
- Relapsing remitting multiple sclerosis
- Ulcerative colitis
Common side effects
- Upper respiratory infection
- Liver test increased
- Headache
- Pyrexia
- Nausea
- Arthralgia
- Hepatic transaminase elevation
- Orthostatic hypotension
- Urinary tract infection
- Back pain
- Hypertension
- Upper abdominal pain
Key clinical trials
- Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
- A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis (PHASE2,PHASE3)
- Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects
- Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
- An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice (PHASE4)
- Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis (PHASE3)
- An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (PHASE3)
- A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zeposia CI brief — competitive landscape report
- Zeposia updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI