Last update 11 Aug 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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
18,494
fcrfjipjol(gdzbwemiie) = lewfsiktwz uvwxhxpfne (iwslxxtjdr )
Positive
02 May 2026
fcrfjipjol(pluwoqkior) = pbsnzckwyo pgtdjsdwyl (kwsvuwmjje )
Phase 4
139
(Cohort 1: Ozanimod Advanced Therapy Naïve)
jxzfcdcelc = lcctoipnnk jszyshrbcr (ptgmecafxq, mrteqnoaft - jyplsdfnxf)
-
10 Feb 2026
(Cohort 2: Ozanimod Advanced Therapy Exposed)
xspjkvyfag = aiscsjedfx ekzfvyhnlt (vopufjjfwk, ibkgcysniu - ngdvjhnuar)
Phase 3
188
fiahxfrdne(vntdbtnyhr) = iajmdziynu baxypibvmq (ojtcupmmob )
Positive
05 Feb 2026
Phase 3
Multiple sclerosis relapse
Neurofilament light chain (NfL)
157
(early relapsing multiple sclerosis)
jtywoasbem(shxpozopek) = uxgfpxzesz txymapvwsi (zqhnabbmhe )
Positive
05 Feb 2026
Not Applicable
23
oyqkupmfwo(yckoutextc) = rvoypwkauf rvobctpzzx (ntdfycyaac )
Positive
05 Feb 2026
Not Applicable
85
vhjcsyvxqj(htkfllzsih) = sxzfrswkxz vasmzqswav (njgozdxajd )
Positive
05 Feb 2026
Phase 3
877
Placebo
(RPC01-3101 Placebo-Placebo)
nbyyzzsukw = pmsqchvqag yqfigdqfzz (fctwkcyqni, maxcnsnwka - ilterassuk)
-
31 Dec 2025
Placebo+Ozanimod
(RPC01-3101 Ozanimod-Placebo)
nbyyzzsukw = evkatupsmb yqfigdqfzz (fctwkcyqni, vafuhwopnx - oskxnwlssl)
Phase 3
625
(Treatment 1)
bgzflbkmxs = dmfiksidqi raaqyieytn (ixmveilelw, vvnzmldanz - nbnnjjprxu)
-
04 Nov 2025
placebo+ozanimod
(Treatment 2)
bgzflbkmxs = aavjponhau raaqyieytn (ixmveilelw, bohqbtmpus - ozpxxksiep)
Phase 3
2,494
htvvwdbjsa(olcetqvrex) = uxnhyhkzdk xivyzaklen (xcdwtqzwja, 0.082 - 0.117)
Positive
01 Nov 2025
Phase 3
550
(Ozanimod 0.92 mg / Ozanimod 0.92 mg)
rlaucusvdm = rzryqujckx qlrlqqssiy (ojnworvwqa, nryhcxbkzt - wdriendhay)
-
09 Oct 2025
(Ozanimod 0.92 mg / Placebo)
rlaucusvdm = oglvincrln qlrlqqssiy (ojnworvwqa, afeotsmzrb - gahsczxkzq)
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Regulation

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