Friday, July 10, 2026

Drug profile · INN

ozanimod

ozanimod (ZEPOSIA) is a sphingosine 1-phosphate receptor edg-1 modulator. Associated with Bristol-Myers Squibb Australia Pty Ltd. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AA38
US status approved
Patents linked 0
Pipeline programs 7
News articles 0
Drug details — ozanimod
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
Patents
0
Programs
7
Data quality
0.83

Quick answer

ozanimod (ZEPOSIA) is a sphingosine 1-phosphate receptor edg-1 modulator. Associated with Bristol-Myers Squibb Australia Pty Ltd. Current US regulatory status: approved.

Key facts

INN ozanimod
Brand ZEPOSIA
Mechanism Sphingosine 1-phosphate receptor Edg-1 modulator
Target Sphingosine 1-phosphate receptor 5
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Formulation CAPSULE
ATC code L04AA38

Mechanism of action

Sphingosine 1-phosphate receptor Edg-1 modulator

Primary target: Sphingosine 1-phosphate receptor 5

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. IM047-001 Phase 3 · Bristol-Myers Squibb Australia · Moderately to Severely Active Ulcerative Colitis
  2. IM047-023 Phase 3 · Celgene · Moderately to Severely Active Crohn's Disease
  3. IM047-050 Phase 3 · Bristol-Myers Squibb Australia · Relapsing Remitting Multiple Sclerosis
  4. Ozanimod, Ozanimod Phase 3 · Celgene · Ulcerative colitis
  5. Ozanimod, Ozanimod Phase 3 · Celgene · Moderately to Severely Active Crohn's Disease
  6. RPC01-3203 Phase 3 · Celgene · Moderately to Severely Active Crohn's Disease
  7. Zeposia 0.92 mg hard capsules Approved · Théa Pharma Ireland · Relapsing Multiple Sclerosis (relapsing-remitting, relapsing

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is ozanimod?

ozanimod (ZEPOSIA) is a sphingosine 1-phosphate receptor edg-1 modulator. Associated with Bristol-Myers Squibb Australia Pty Ltd. Current US regulatory status: approved.

What is the brand name for ozanimod?

ZEPOSIA is a marketed brand name for ozanimod. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ozanimod?

ozanimod has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.