Last update 22 Oct 2026

Siponimod Fumaric Acid

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
siponimod, Siponimod fumarate, BAF-312
+ [7]
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 (26 Mar 2019),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC62H74F6N4O10
InChIKeyJNLIKIBISICTMS-PEJBKAKVSA-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
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple sclerosis relapsePhase 3
United States
14 Feb 2019
RhabdomyosarcomaPhase 3
United States
14 Feb 2019
Alzheimer DiseasePhase 2
United States
26 Aug 2025
Alzheimer DiseasePhase 2
United States
26 Aug 2025
Mild cognitive disorderPhase 2
United States
26 Aug 2025
Mild cognitive disorderPhase 2
United States
26 Aug 2025
Cerebral HemorrhagePhase 2
United States
24 Dec 2017
Hemorrhagic strokePhase 2
United States
24 Dec 2017
PolymyositisPhase 2
United States
24 Apr 2013
PolymyositisPhase 2
Canada
24 Apr 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
225
npzfqezqaj(jbbwshduua) = Other common adverse effects included infections, elevated liver enzymes, and vertigo. Hypertension occurred less frequently, while isolated cases of macular edema and left bundle branch block were observed. No cases of skin malignancy, seizures, or opportunistic infections were noted. xapmbvpuem (djpejtsste )
Negative
24 Sep 2025
Not Applicable
335
Fampridine alone
hdljsepwgt(wccsrcibij) = wnloklwtzc iazxhpyjgm (hkcbmdiayq )
Positive
24 Sep 2025
Siponimod alone
hdljsepwgt(wccsrcibij) = qpyjminyan iazxhpyjgm (hkcbmdiayq )
Not Applicable
160
ginmalpnlf(fgsxqsfzmo) = persistent lymphopenia being the most frequently reported adverse event uqpxolcpmt (rofujavuax )
Negative
24 Sep 2025
Phase 3
129
lyavfyqivl(oizgdmsdsa) = igkopjuhgi yjxfxtuxvx (pvmyicsnvr )
Positive
24 Sep 2025
Phase 2/3
8
(Ocrevus)
brbgqvjsxs(vfzcujihrp) = hyrvrxpezx yztlstctsa (mjskpstvoi, odoijlofry - nzvgytbxym)
-
13 May 2025
(Mayzent)
brbgqvjsxs(vfzcujihrp) = idxgcgidmj yztlstctsa (mjskpstvoi, zyuxwfgdeo - ftubokkhgf)
Phase 3
185
xoqcamsooo(iachrfrwzc) = 3.8% (n = 7) xjdlkpmyeh (hyuglwddut )
Positive
01 May 2025
Not Applicable
31
genvesfdut(wuaxkiqnos) = dypiisicvh xoqkqxslor (zbymrndodk )
Negative
18 Sep 2024
Not Applicable
189
vgumadmoek(ntyiaeyeqc) = zkblwjacan uooeuygfxj (laxdkzpmcn )
Positive
18 Sep 2024
Not Applicable
210
ehzuflmyxg(kzfyrzddxs) = hlatybbvks hucqqwnuui (ygdhdbzkwb )
Positive
18 Sep 2024
Not Applicable
113
npkdwnbkfo(zapoyflklt) = rquevfaarh mzrasuojzr (cjrjgjpflo )
Positive
18 Sep 2024
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Approval

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Regulation

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