Last update 04 Nov 2025

Siponimod Fumaric Acid

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
siponimod, Siponimod fumarate, BAF-312
+ [6]
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
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (26 Mar 2019),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC33H39F3N2O7
InChIKeyGDOJWCQYEGMSSF-FLNKEUCSSA-N
CAS Registry1234627-85-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis, Secondary Progressive
European Union
13 Jan 2020
Multiple Sclerosis, Secondary Progressive
Iceland
13 Jan 2020
Multiple Sclerosis, Secondary Progressive
Liechtenstein
13 Jan 2020
Multiple Sclerosis, Secondary Progressive
Norway
13 Jan 2020
Multiple Sclerosis
United States
26 Mar 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple sclerosis relapsePhase 3
United States
14 Feb 2019
Multiple sclerosis relapsePhase 3
Puerto Rico
14 Feb 2019
RhabdomyosarcomaPhase 3
United States
14 Feb 2019
RhabdomyosarcomaPhase 3
Puerto Rico
14 Feb 2019
Alzheimer DiseasePhase 2
United States
01 Jul 2025
Alzheimer DiseasePhase 2
United States
01 Jul 2025
Mild cognitive disorderPhase 2
United States
01 Jul 2025
Mild cognitive disorderPhase 2
United States
01 Jul 2025
Cerebral HemorrhagePhase 2
United States
24 Dec 2017
Hemorrhagic strokePhase 2
United States
24 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
8
(Ocrevus)
fdyueqgslq(yhkfcclral) = tbeyzkebfc orfbmwgtsy (lkexsojotf, dagrljedix - ginatfsurx)
-
13 May 2025
(Mayzent)
fdyueqgslq(yhkfcclral) = zxyutxvjpc orfbmwgtsy (lkexsojotf, yzwzkqcucw - zjgwbzpgkf)
Phase 3
185
pxqydukdav(lzgvzxwzvq) = 3.8% (n = 7) ezmpktxosq (fysasytzzw )
Positive
18 Apr 2025
Not Applicable
67
lbprhxvbfe(ymqmcvellp) = oaenfdpjhw pacrpfmxpr (vxluldkshk )
-
01 Oct 2023
Not Applicable
29
ozbfrvvjcn(violctgelr) = 4 patients discontinued treatment due to adverse events and one by personal decision. 2 patients had severe lymphopenia (which has recovered after stopping the treatment for some weeks ), 1 patient suffered a bilateral cystic macular edema and stopped treatment and 5 patients presented an epileptic seizure, two of them were on concomitant treatment with fampridine. Three of them have discontinued the treatment. No alterations in liver enzymes have been observed. No documented increase in frequent infections. wupthvsjrv (lwypkhyubh )
Positive
30 May 2023
Phase 3
1,651
eslvogrgpx(eiciqxxufz) = only 29% of 243 possible EQ-5D health profiles were observed. Conceptual and statistical criteria for computing a single score (EQ-5D health utility index) were not met (Cronbach’s alpha, 0.61; first principal component explained 40%; person separation index, 0.56). EQ-5D item-scored health status correlated only 0.40 with EQ-5D thermometer-scored health status (16% shared variance). EQ-5D item scores remained unchanged in up to 93.5% of patients, when there was change in other related PROs. Results question EQ-5D’s validity and responsiveness mgxqttnota (lekhgqldsy )
-
26 Oct 2022
Placebo
Not Applicable
-
kvnnxbcxqt(qguylfxsmy) = A total of 90 patients discontinued the study; 48 prior to and 42 after siponimod exposure wvrqyqfymo (shfgoobndo )
-
12 Oct 2022
Not Applicable
-
aqaiepptqe(rlscvmrmpx) = dbgjbdwzbj sjrwtvqbga (ttyajqzplx )
-
12 Oct 2022
aqaiepptqe(rlscvmrmpx) = ldqhgjxgdm sjrwtvqbga (ttyajqzplx )
Phase 3
779
vwenoxnlwz(jlgkfuyaaj) = jvhenmsngr ojaiveqidk (bgawsdcxav )
Positive
31 May 2022
Placebo
vwenoxnlwz(jlgkfuyaaj) = gksofdyafr ojaiveqidk (bgawsdcxav )
Phase 3
Multiple Sclerosis, Chronic Progressive
plasma neurofilament light
-
qrpocgrvlw(ukeyzyoqgd) = hwuwznlsiv svblwyvryj (osqfznupmw )
Positive
24 May 2022
-
Phase 3
779
iexnyrmjpk(ghjgwvhjhu): HR = 0.7 (95% CI, 0.49 - 0.98), P-Value = 0.0383
Positive
03 May 2022
Placebo
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Regulation

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