Last update 04 Nov 2024

Ozanimod Hydrochloride

Overview

Basic Info

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

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
US
27 May 2021
Multiple sclerosis relapse
AU
17 Jul 2020
Multiple Sclerosis, Relapsing-Remitting
EU
20 May 2020
Multiple Sclerosis, Relapsing-Remitting
IS
20 May 2020
Multiple Sclerosis, Relapsing-Remitting
LI
20 May 2020
Multiple Sclerosis, Relapsing-Remitting
NO
20 May 2020
Ulcerative colitis, active moderate
EU
20 May 2020
Ulcerative colitis, active moderate
IS
20 May 2020
Ulcerative colitis, active moderate
LI
20 May 2020
Ulcerative colitis, active moderate
NO
20 May 2020
Ulcerative colitis, active severe
EU
20 May 2020
Ulcerative colitis, active severe
IS
20 May 2020
Ulcerative colitis, active severe
LI
20 May 2020
Ulcerative colitis, active severe
NO
20 May 2020
Multiple Sclerosis
US
25 Mar 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseaseNDA/BLA
CN
30 Jul 2021
COVID-19Phase 2
CA
16 Sep 2020
Liver DiseasesPhase 1
US
18 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
2,257
kroacsyida(dvfqjiatga) = ytuojqrcyv pejqlhzntl (gzsxbcvrmb )
Positive
18 Sep 2024
Phase 3
616
(TN study)
qnxepuplnw(itucpteqoz) = pojxmxgyfx dgbeanpywd (fcupkllmdr )
Positive
07 May 2024
Placebo
(TN study)
qoabvfxysv(idnrglqvfl) = lysqupsyke zmkrnxjsoa (nlinpptobq )
Phase 3
600
sgubhryhei(khnvutbhry) = did not meet bvdgjlujrn (ocknoxntif )
Not Met
Negative
29 Mar 2024
Not Applicable
101
xgnusuunwv(jhhqzrwxbu) = ljytxbdgus clpvrdunfc (bsquihoqam )
Positive
01 Mar 2024
xgnusuunwv(jhhqzrwxbu) = wjgahghnpm clpvrdunfc (bsquihoqam )
Not Applicable
58
wvndzijmgq(yvgpusmcxx) = Opportunistic infections were reported in 2 patients: shingles (n=1) and oral thrush (n=1). No cardiac events were reported. wjuztbmgxn (tyrtudkrun )
Positive
01 Mar 2024
Phase 3
116
xpfiyvbnvm(emvourwiwc): Z-score = 0.005
Positive
01 Mar 2024
Placebo
Phase 3
-
-
lvotutphfs(rsjxusplpx) = dyyynfmhgt dfgnqtgoep (nztnykbxsv )
Positive
01 Mar 2024
IFN
lvotutphfs(rsjxusplpx) = uvvuhjcxvb dfgnqtgoep (nztnykbxsv )
Phase 3
544
(discontinued the study early)
wgiereyqax(zcxsrbkizx) = rtcjomspvq pvufkhfcbj (sweavloepm )
Positive
29 Feb 2024
Phase 3
2,639
anynjekepr(hgxjnsusml) = pvymzcepcu pbjuuuoffb (coizdoiadr )
Positive
29 Feb 2024
Phase 3
2,494
IFN-B-1a
(Parent Treatment Group IFN-B-1a 30 ug)
gbhqhdkini(glnamfxeud) = mrabwkuykn pocodnhduw (yxfgysuoqt, kxkmtshsaq - ppqipmwucy)
-
30 Jan 2024
(Parent Treatment Group: RPC1063 0.5 mg)
gbhqhdkini(glnamfxeud) = dzptkpbyoa pocodnhduw (yxfgysuoqt, fwlbqolybk - bbotlflbbh)
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Approval

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Regulation

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