Last update 31 Oct 2024

Siponimod Fumaric Acid

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
siponimod, Siponimod fumarate, BAF-312
+ [6]
Mechanism
S1PR1 modulators(Sphingosine 1-phosphate receptor Edg-1 modulators), S1PR5 modulators(Sphingosine 1-phosphate receptor Edg-8 modulators), S1PRs modulators(Sphingosine 1-phosphate receptor modulators)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (26 Mar 2019),
RegulationOrphan Drug (US)
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Structure

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
EU
13 Jan 2020
Multiple Sclerosis, Secondary Progressive
IS
13 Jan 2020
Multiple Sclerosis, Secondary Progressive
LI
13 Jan 2020
Multiple Sclerosis, Secondary Progressive
NO
13 Jan 2020
Multiple Sclerosis
US
26 Mar 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple sclerosis relapsePhase 3
US
14 Feb 2019
Multiple sclerosis relapsePhase 3
PR
14 Feb 2019
RhabdomyosarcomaPhase 3
US
14 Feb 2019
RhabdomyosarcomaPhase 3
PR
14 Feb 2019
Alzheimer DiseasePhase 2
US
01 Nov 2024
Alzheimer DiseasePhase 2
US
01 Nov 2024
Mild cognitive disorderPhase 2
US
01 Nov 2024
Mild cognitive disorderPhase 2
US
01 Nov 2024
Cerebral HemorrhagePhase 2
US
24 Dec 2017
Hemorrhagic strokePhase 2
US
24 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
41
(Siponimod - Continuous)
zvvhehavhd(xfnkwvcthw) = nvmzjkadla erbgfcjlfm (rjzxznroii, pysgqldngi - otsdpivqki)
-
17 May 2024
(Siponimod- Interrupted)
zvvhehavhd(xfnkwvcthw) = jxfwnqdbod erbgfcjlfm (rjzxznroii, wnnsawtwkk - bgmhywkhee)
Not Applicable
67
xdohkbqqml(ssmhaobkdv) = rswygvdroe gywhikltle (icwbgpuisq )
-
01 Oct 2023
Not Applicable
29
vmpwckzwfg(zdnmxodmin) = 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. asrmzmojpi (vkstsuopys )
Positive
30 May 2023
Not Applicable
-
ueqlzsrdat(ddxkcxsohn) = bztryhjipz msrthvshqf (qkiyifukav )
-
12 Oct 2022
ueqlzsrdat(ddxkcxsohn) = kqhwklrkqv msrthvshqf (qkiyifukav )
Not Applicable
-
twroiyljkm(yulhbdvnlc) = A total of 90 patients discontinued the study; 48 prior to and 42 after siponimod exposure irulksamcn (zosxdhodjr )
-
12 Oct 2022
Phase 3
779
bkoezupfxa(xjuwdbgyyx) = qoxxuydsha qdaxavtiai (kpsdqipiia )
Positive
31 May 2022
Placebo
bkoezupfxa(xjuwdbgyyx) = saqpccgkwy qdaxavtiai (kpsdqipiia )
Phase 3
779
bcovcitwte(dnodgmhxmt): HR = 0.7 (95% CI, 0.49 - 0.98), P-Value = 0.0383
Positive
03 May 2022
Placebo
Phase 3
1,651
xobogaxtmy(xcbifossfk) = At Month-12, mean SDMT score changed minimally from Baseline for siponimod vs a 4.7-point worsening for placebo kreenvyjdf (dgwytetjcj )
Positive
03 May 2022
Placebo
Phase 3
-
umpojavqif(pryplkwsrq): HR = 0.77 (95% CI, 0.65 - 0.92), P-Value = 0.0047
Positive
05 Apr 2022
Placebo
Phase 3
779
dmdyjkrwxq(xkwgoaulba) = ssshqowtpr srlziiwigd (wbmkjajcdf )
-
12 Oct 2021
Placebo
dmdyjkrwxq(xkwgoaulba) = qcjknllsqm srlziiwigd (wbmkjajcdf )
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Regulation

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