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ozanimod

Trade name: Zeposia

Small moleculeapproved

Approved

Mar 25, 2020

Ozanimod, sold under the brand name Zeposia, is an immunomodulatory medication for the treatment of relapsing multiple sclerosis and ulcerative colitis. It acts as a sphingosine-1-phosphate receptor (S1PR) agonist, sequestering lymphocytes to peripheral lymphoid organs and away from their sites of chronic inflammation. — Wikipedia

Clinical trial activity

49 trials · 9 clinical orgs · 4 marketing orgs

Phase 1
21
Phase 2
19
Phase 3
16
Phase 4
6

Earliest trial started Jul 1, 2012 (NCT01628393)

Timeline

2010s

  1. Jan 1, 2012

    Celgene — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2013

    Celgene — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2016

    Celgene — Earliest Phase 1 Sponsor(trial)

2020s

  1. Mar 25, 2020

    Bristol-Myers Squibb — Earliest FDA Approval

  2. Mar 25, 2020

    Celgene — Marketing Organization

  3. Mar 25, 2020

    Bristol-Myers Squibb — NDA Secondary Org

  4. Mar 25, 2020

    Bristol-Myers Squibb — NDA Organization

  5. Mar 25, 2020

    Bristol-Myers — Marketing Organization

  6. Jul 22, 2025

    Byondis — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 25, 2020

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)Oc1ccc(-c2nc(-c3cccc4c3CC[C@@H]4NCCO)no2)cc1C#N
Mol. weight
404.47 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • ozanimod
  • ozanimod
  • ozanimod
  • rpc1063
  • rpc1063
  • rpc1063

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06862960Phase 2May 1, 2025Fujian Medical University
NCT06408259Phase 3Jan 28, 2025Bristol-Myers Squibb, Celgene
NCT06188637Phase 4Aug 1, 2024Bristol-Myers Squibb, University of Amsterdam
NCT06529406Phase 4Jul 29, 2024University of Colorado, Denver
NCT06334094Phase 4Jun 1, 2024The University of Texas, Dallas
NCT06396039Phase 4May 15, 2024Bristol-Myers Squibb
NCT06088264Phase 1Oct 31, 2023Bristol-Myers Squibb
NCT05730725Phase 2Apr 3, 2023Bristol-Myers Squibb
NCT05777902Phase 4Jan 31, 2023I.R.C.C.S. Fondazione Santa Lucia
NCT05470985Phase 2/Phase 3 (Phase 3)Dec 16, 2022Bristol-Myers Squibb
NCT05644665Phase 3Dec 9, 2022Bristol-Myers Squibb
NCT05369832Phase 4Nov 18, 2022Bristol-Myers Squibb
NCT05615012Phase 1Nov 10, 2022Bristol-Myers Squibb
NCT05579574Phase 1Oct 21, 2022Bristol-Myers Squibb
NCT05546151Phase 1Sep 23, 2022Bristol-Myers Squibb
NCT05076175Phase 2/Phase 3 (Phase 3)Oct 29, 2021Bristol-Myers Squibb
NCT05001152Phase 1Sep 9, 2021Bristol-Myers Squibb
NCT04978298Phase 1Jul 19, 2021Celgene
NCT04639115Phase 1Nov 20, 2020Bristol-Myers Squibb, Celgene
NCT04528290Phase 1Sep 17, 2020Bristol-Myers Squibb, Celgene
Showing 20 of 49 trials
Page 1 / 3

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CelgeneFor profit262532012
Bristol-Myers SquibbFor profit231742017
Fujian Medical UniversityAcademic/Hospital1112025
I.R.C.C.S. Fondazione Santa LuciaAcademic/Hospital1112023
Laval UniversityAcademic/Hospital1112020
New York UniversityAcademic/Hospital1112019
The University of Texas, DallasAcademic/Hospital1112024
University of AmsterdamAcademic/Hospital1112024
University of Colorado, DenverAcademic/Hospital1112024
9 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
Bristol-MyersFor profitMKTGMar 25, 2020
Bristol-Myers SquibbFor profitNDA2Mar 25, 2020
Bristol-Myers SquibbFor profitNDAMar 25, 2020
ByondisFor profitMKTGJul 22, 2025
CelgeneFor profitMKTGMar 25, 2020