Drug Type Small molecule drug |
Synonyms Ozanimod, Ozanimod hydrochloride (USAN), Ozanimod-HCl + [10] |
Target |
Action modulators |
Mechanism S1PR1 modulators(Sphingosine 1-phosphate receptor Edg-1 modulators), S1PR5 modulators(Sphingosine 1-phosphate receptor Edg-8 modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (25 Mar 2020), |
RegulationOrphan Drug (United States) |
Molecular FormulaC23H25ClN4O3 |
InChIKeyHAOOCAKHSFYDBU-BDQAORGHSA-N |
CAS Registry1618636-37-5 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10967 | Ozanimod Hydrochloride |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Colitis, Ulcerative | United States | 27 May 2021 | |
| Multiple sclerosis relapse | Australia | 17 Jul 2020 | |
| Multiple Sclerosis, Relapsing-Remitting | European Union | 20 May 2020 | |
| Multiple Sclerosis, Relapsing-Remitting | Iceland | 20 May 2020 | |
| Multiple Sclerosis, Relapsing-Remitting | Liechtenstein | 20 May 2020 | |
| Multiple Sclerosis, Relapsing-Remitting | Norway | 20 May 2020 | |
| Ulcerative colitis, active moderate | European Union | 20 May 2020 | |
| Ulcerative colitis, active moderate | Iceland | 20 May 2020 | |
| Ulcerative colitis, active moderate | Liechtenstein | 20 May 2020 | |
| Ulcerative colitis, active moderate | Norway | 20 May 2020 | |
| Ulcerative colitis, active severe | European Union | 20 May 2020 | |
| Ulcerative colitis, active severe | Iceland | 20 May 2020 | |
| Ulcerative colitis, active severe | Liechtenstein | 20 May 2020 | |
| Ulcerative colitis, active severe | Norway | 20 May 2020 | |
| Multiple Sclerosis | United States | 25 Mar 2020 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Crohn Disease | NDA/BLA | China | 30 Jul 2021 | |
| Pediatric Crohn's Disease | Phase 3 | United States | 22 Aug 2023 | |
| Pediatric Crohn's Disease | Phase 3 | Australia | 22 Aug 2023 | |
| Pediatric Crohn's Disease | Phase 3 | Belgium | 22 Aug 2023 | |
| Pediatric Crohn's Disease | Phase 3 | Canada | 22 Aug 2023 | |
| Pediatric Crohn's Disease | Phase 3 | France | 22 Aug 2023 | |
| Pediatric Crohn's Disease | Phase 3 | Germany | 22 Aug 2023 | |
| Pediatric Crohn's Disease | Phase 3 | Hungary | 22 Aug 2023 | |
| Pediatric Crohn's Disease | Phase 3 | Poland | 22 Aug 2023 | |
| Pediatric Crohn's Disease | Phase 3 | Spain | 22 Aug 2023 |
Phase 3 | 854 | (RPC01-3201/3202 Placebo) | fhhgbytbkb = xezvnpysnj phmobrkhay (ljlbudbcdn, ttuxqmljsy - rsfzwbpyhn) View more | - | 17 Sep 2025 | ||
RPC01+Ozanimod (RPC01-3201/3202 Ozanimod 0.92 mg) | fhhgbytbkb = zkjlwlwwfx phmobrkhay (ljlbudbcdn, cnopxxwtiu - irnvltujbx) View more | ||||||
Phase 2/3 | 5 | (Ozanimod 0.46 mg) | ouioaymthw = fitkdrwoie vgumuqkkgp (sefthdyicr, cospnztxin - ksrzbdtsot) View more | - | 22 Apr 2025 | ||
(Ozanimod 0.92 mg) | idbwvdzvyd = cwapiecsvw wovcrtntcp (oqutasdjot, vwyeqgihnr - uqokkihsvs) View more | ||||||
Phase 3 | Multiple sclerosis relapse GFAP | NfL | Tau | 163 | qatyuqjnof(vsfgcgfxah) = rrzbcqcdbx fhmlejgsgx (xtadcxaaae ) View more | Positive | 07 Apr 2025 | ||
(Healthy Controls) | qatyuqjnof(vsfgcgfxah) = sbbhisvrlh fhmlejgsgx (xtadcxaaae ) View more | ||||||
Phase 3 | 188 | jliqlbvkjk(oxeskvejct) = 25.0% wsctmumxsf (qekzvujqsi ) View more | Positive | 07 Apr 2025 | |||
Phase 3 | 606 | (Ozanimod) | cgjftnkida = ezykzatxmk ogjyjvgfkt (mkccomyajb, rhwahxawkg - liviljtrym) View more | - | 05 Dec 2024 | ||
Placebo (Placebo) | cgjftnkida = kxuevzkucc ogjyjvgfkt (mkccomyajb, ycmqifdpzc - hguxksbtgu) View more | ||||||
Phase 3 | 131 | gjxemdllly(fhaepdegnp) = sunmuhdhfb ywgjfjvmvz (hcggguerge ) View more | Positive | 13 Oct 2024 | |||
Not Applicable | - | nssibsqail(iefkupwqki) = n=2, 1.8% tyshpxydic (cdfpwnhedf ) View more | - | 13 Oct 2024 | |||
Phase 1 | - | 78 | tdfkeqdtcm(sktxthrgnh) = ALC decrease was similar across OZA groups and was not dose dependent wnvipglmsf (cowcgkqkdv ) View more | Positive | 13 Oct 2024 | ||
Phase 3 | 2,257 | pfxdjffkto(uddngxwbxu) = vczlxfxfrz hlmgvamisp (ofobfjmgeh ) | Positive | 18 Sep 2024 | |||
Phase 3 | - | 2,494 | Ozanimod 0.92 mg/d | kuqxvmogjy(lysbekqpjj) = asemyxhtka zesogwbavn (xnzgrpxkuk ) View more | Positive | 28 Jun 2024 |





