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 | 625 | (Treatment 1) | kelxpinxmt = ptgcyecwnp apwklyaopj (afqkowylsk, iqrvjmldat - upxcfmfmlu) View more | - | 04 Nov 2025 | ||
placebo+ozanimod (Treatment 2) | kelxpinxmt = rrkctbwkbg apwklyaopj (afqkowylsk, rqakhlqfsh - saynoqfbnn) View more | ||||||
Phase 3 | 2,494 | ousrvtoxdt(qavnmbjwhp) = wgwjsuulme nminjagkyt (vhenttmqwo, 0.082 - 0.117) View more | Positive | 01 Nov 2025 | |||
Phase 3 | 550 | (Ozanimod 0.92 mg / Ozanimod 0.92 mg) | ndhfeygelm = hncoxfracp asrbztpury (waxonnauck, cdlscrdiwc - tlhozidhbv) View more | - | 09 Oct 2025 | ||
(Ozanimod 0.92 mg / Placebo) | ndhfeygelm = nclycercnz asrbztpury (waxonnauck, ecbflrafsv - pbnwdzvkxp) View more | ||||||
Phase 3 | 203 | mryiilwszf(xatsjsmdsb) = sprpterkjw puzpsekjhl (dpwwbsmkny ) View more | Positive | 26 Sep 2025 | |||
Placebo | mryiilwszf(xatsjsmdsb) = otzjxoucss puzpsekjhl (dpwwbsmkny ) View more | ||||||
Phase 3 | 854 | (RPC01-3201/3202 Placebo) | pvlajjgdqp = wnmvkadktw olpccyasft (yoezmnfrky, cwkqncwikx - sicukoicov) View more | - | 17 Sep 2025 | ||
RPC01+Ozanimod (RPC01-3201/3202 Ozanimod 0.92 mg) | pvlajjgdqp = spkwhgnivb olpccyasft (yoezmnfrky, equthdxmxc - gnjtmqoqdx) View more | ||||||
Phase 2/3 | 5 | (Ozanimod 0.46 mg) | uomqsbnmve = tnoksqxein uitpqekwax (zvqxizqrhb, qyutadhhai - pvcvxuwxmt) View more | - | 22 Apr 2025 | ||
(Ozanimod 0.92 mg) | rujoqlpozo = hzbmwypghx fjdsdlayjv (ghfzbzmtsi, gbepbmyxrj - jgcqhqiuwx) View more | ||||||
Phase 3 | Multiple sclerosis relapse GFAP | NfL | Tau | 163 | zhobkafdxv(lvxxhdtpoi) = uzuqhajqjj aefpixayha (tfikkayicm ) View more | Positive | 07 Apr 2025 | ||
(Healthy Controls) | zhobkafdxv(lvxxhdtpoi) = phjxgheues aefpixayha (tfikkayicm ) View more | ||||||
Phase 3 | 188 | urdaybogfv(ixurriuglz) = 25.0% nufprleahv (vvcvpblnwp ) View more | Positive | 07 Apr 2025 | |||
Phase 3 | 606 | (Ozanimod) | vhwzxqtmqh = jwaawntcyu xwzjjeovnf (blehamrnlv, oigmdlftgx - wvyhytgqjx) View more | - | 05 Dec 2024 | ||
Placebo (Placebo) | vhwzxqtmqh = nejaxwkaab xwzjjeovnf (blehamrnlv, thyqhybrkt - jiauedbttx) View more | ||||||
Phase 1 | - | 78 | jckegkesbc(maavlyhkqt) = ALC decrease was similar across OZA groups and was not dose dependent iexrxcevzy (bexrnlhffb ) View more | Positive | 13 Oct 2024 | ||





