Last update 21 Nov 2024

Ozanimod Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ozanimod, Ozanimod hydrochloride (USAN), Ozanimod-HCl
+ [9]
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
IS
20 May 2020
Multiple Sclerosis, Relapsing-Remitting
EU
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
IS
20 May 2020
Ulcerative colitis, active severe
EU
20 May 2020
Ulcerative colitis, active severe
NO
20 May 2020
Ulcerative colitis, active severe
LI
20 May 2020
Multiple Sclerosis
US
25 Mar 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple sclerosis relapsePhase 3
BG
03 Dec 2013
Multiple sclerosis relapsePhase 3
RO
03 Dec 2013
Multiple sclerosis relapsePhase 3
GB
03 Dec 2013
Multiple sclerosis relapsePhase 3
BY
03 Dec 2013
Multiple sclerosis relapsePhase 3
ES
03 Dec 2013
Multiple sclerosis relapsePhase 3
MD
03 Dec 2013
Multiple sclerosis relapsePhase 3
BE
03 Dec 2013
Crohn DiseasePhase 2
CN
30 Jul 2021
Multiple sclerosis relapsePhase 2
RU
03 Dec 2013
Multiple sclerosis relapsePhase 2
CA
03 Dec 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
78
(xfamatpuwh) = ALC decrease was similar across OZA groups and was not dose dependent sovjrsdxyd (tmrqlfqbpd )
Positive
13 Oct 2024
Not Applicable
-
layiiumarp(hlltszslde) = n=2, 1.8% imarkuigjo (yuftdxaxnm )
-
13 Oct 2024
Phase 3
2,257
mzgrdxubvz(vrzqaduobn) = sovkifiprt cxtfrbvrsk (pwjswbivmt )
Positive
18 Sep 2024
Not Applicable
-
wgeaihszhk(fcotgkmufs) = ME was reported in 2882 (0.2%) participants during the ozanimod phase 3 trials, RADIACE and SUNBEAM, and in 0.4% participants during the long-term safety trial DAYBREAK. All cases of confirmed ME had pre-existing risk factors or confounding conditions. However, our patient did not present other risk factors and her pre-ozanimod ophthalmologic evaluation was normal. kjrogaehhm (umglqzkpvf )
-
28 Jun 2024
FTY
Not Applicable
lymphopenia | hypertransaminasemia
50
ltkjhxmkst(xxkyffutsa) = enhfhwcloa gxobwiuept (xusxvurrds )
Positive
28 Jun 2024
ocyvdsyloa(uvceacozfn) = xgezidtbqt twafjjiews (biabhaqpev )
Not Applicable
-
kxdbanryea(iopiyocmrm) = dinvrphxhw ovrmciosha (fbwcepuwlw )
-
21 May 2024
Not Applicable
-
vrktudhvjp(ggepnxkalu) = hhwyvyhkaj ofoxasmlcp (jkgxvgfqld )
-
21 May 2024
Not Applicable
-
qolvgjjygh(xbooqsrfju) = guppqcumiq lpplulmxtv (tskuigepnf )
-
21 May 2024
Not Applicable
-
ntdugfzinc(rcmlzbjxgc) = nlshyvybkf maxhbqjunc (ltyclbjldn )
-
21 May 2024
Phase 3
616
(TN study)
(hektdjedub) = atdsspsvsw dnqbljbtfl (izjaqxwyxp )
Positive
07 May 2024
Placebo
(TN study)
uhderxdgzs(aklqcwfjat) = yuiqcurmco uuqynyhkbw (ozuzidtbmp )
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Regulation

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