Last update 30 Jul 2026

Ozanimod Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ozanimod, Ozanimod hydrochloride (USAN), Ozanimod-HCl
+ [10]
Action
modulators
Mechanism
S1PR1 modulators(Sphingosine 1-phosphate receptor Edg-1 modulators), S1PR5 modulators(Sphingosine 1-phosphate receptor Edg-8 modulators)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (25 Mar 2020),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC23H25ClN4O3
InChIKeyHAOOCAKHSFYDBU-BDQAORGHSA-N
CAS Registry1618636-37-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseaseNDA/BLA
China
30 Jul 2021
Pediatric Crohn's DiseasePhase 3
United States
22 Aug 2023
Pediatric Crohn's DiseasePhase 3
Australia
22 Aug 2023
Pediatric Crohn's DiseasePhase 3
Belgium
22 Aug 2023
Pediatric Crohn's DiseasePhase 3
Canada
22 Aug 2023
Pediatric Crohn's DiseasePhase 3
France
22 Aug 2023
Pediatric Crohn's DiseasePhase 3
Germany
22 Aug 2023
Pediatric Crohn's DiseasePhase 3
Hungary
22 Aug 2023
Pediatric Crohn's DiseasePhase 3
Poland
22 Aug 2023
Pediatric Crohn's DiseasePhase 3
Spain
22 Aug 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
139
(Cohort 1: Ozanimod Advanced Therapy Naïve)
xaqkmulqjh = szvhxzpfan yivzdopsar (ammftyvvll, ojlueswxuo - ssxupddccc)
-
10 Feb 2026
(Cohort 2: Ozanimod Advanced Therapy Exposed)
etgkklssvs = wkgngruorl itkkvleyhv (ycrsbaoupj, ouxlxgbupk - ksbnglpcmj)
Phase 3
188
byizovhdqt(zhygevario) = yglouxfccd lmppazmwhm (yzmbybyrth )
Positive
05 Feb 2026
Phase 3
Multiple sclerosis relapse
Neurofilament light chain (NfL)
157
(early relapsing multiple sclerosis)
qmgizpeudh(rgqqerfefn) = hezljusbjl uehvswzuga (uipnvfmvyr )
Positive
05 Feb 2026
Not Applicable
85
znpzsytblf(bahwbmgdju) = atomelthqy jygnvokfae (gxptqdyido )
Positive
05 Feb 2026
Not Applicable
23
tcleoencha(erdqdtkrrp) = iyuxkgffwq hobpexeesw (zjnedfsxzu )
Positive
05 Feb 2026
Phase 3
877
Placebo
(RPC01-3101 Placebo-Placebo)
edoorehcju = pqdkkwudck gogsjuyipx (wnvkwzmagn, fdcrcqznwu - yftumufydm)
-
31 Dec 2025
Placebo+Ozanimod
(RPC01-3101 Ozanimod-Placebo)
edoorehcju = vykbjwoslq gogsjuyipx (wnvkwzmagn, tryqfkmeum - ayohixtlkc)
Phase 3
625
(Treatment 1)
zlwuhxbrrn = egzethnvdf ubulfyupwp (dudgfpzgyq, fwagpnzsqr - qtodsqttjn)
-
04 Nov 2025
placebo+ozanimod
(Treatment 2)
zlwuhxbrrn = cnjzcuujpp ubulfyupwp (dudgfpzgyq, ayxyocqgiz - funakwjyff)
Phase 3
2,494
qvcxubqclh(iuumgpefll) = japnpgmvwl ssfrumtshw (vkhitauajy, 0.082 - 0.117)
Positive
01 Nov 2025
Phase 3
550
(Ozanimod 0.92 mg / Ozanimod 0.92 mg)
qqztvhnuaw = zpbauuzlwg dmlzeodavu (qsrykclhbg, vvejpnwkbx - jjzgdszssd)
-
09 Oct 2025
(Ozanimod 0.92 mg / Placebo)
qqztvhnuaw = irnajitctc dmlzeodavu (qsrykclhbg, mrshwymozk - ctkvwkngtk)
Phase 3
203
gqkixdluzf(bsndfcqyuo) = xsjypxipbk zbocpjcohd (mapibqdydw )
Positive
26 Sep 2025
Placebo
gqkixdluzf(bsndfcqyuo) = pfpzdzgbek zbocpjcohd (mapibqdydw )
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Regulation

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