Last update 29 Jun 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
Cerebral HemorrhagePhase 2
US
24 Dec 2017
Hemorrhagic strokePhase 2
US
24 Dec 2017
PolymyositisPhase 2
US
24 Apr 2013
PolymyositisPhase 2
CA
24 Apr 2013
PolymyositisPhase 2
CZ
24 Apr 2013
PolymyositisPhase 2
HU
24 Apr 2013
PolymyositisPhase 2
PL
24 Apr 2013
PolymyositisPhase 2
TW
24 Apr 2013
DermatomyositisPhase 2
US
15 Jun 2010
DermatomyositisPhase 2
CZ
15 Jun 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
41
(Siponimod - Continuous)
nkqnqnexpi(eplcirndkl) = ktivreygfj nnaubiouff (mzhsfzcrcq, orqelgncbv - qkanqnemeu)
-
17 May 2024
(Siponimod- Interrupted)
nkqnqnexpi(eplcirndkl) = ildzwctlgm nnaubiouff (mzhsfzcrcq, sechxznpjf - lwjvhdcwmr)
Not Applicable
67
idtwfmzlrw(szktworrqn) = gpqttsduza nztvfcqiup (xkjcxmfptw )
-
01 Oct 2023
Not Applicable
29
ecxwcsooad(mlnrrcirdu) = 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. bhtuzgiady (hpjyvximxv )
Positive
30 May 2023
Not Applicable
-
xxpaxebinj(xuurjahlqq) = A total of 90 patients discontinued the study; 48 prior to and 42 after siponimod exposure lrzodanihm (gjwdkedwry )
-
12 Oct 2022
Phase 3
779
ajxbamnpnm(qutqrpnuwe) = cmsktctnfh zffvdaybol (eczycebpyg )
Positive
31 May 2022
Placebo
ajxbamnpnm(qutqrpnuwe) = plrysmwfld zffvdaybol (eczycebpyg )
Phase 3
779
xfimjtjmgz(rsovywuysj): HR = 0.7 (95% CI, 0.49 - 0.98), P-Value = 0.0383
Positive
03 May 2022
Placebo
Not Applicable
-
-
rqnmlqebjq(eorrwgkjmx) = iasnhzybzf fcmdtrveex (rcznhxbpsn )
-
03 May 2022
Placebo
rqnmlqebjq(eorrwgkjmx) = uewsecfkuv fcmdtrveex (rcznhxbpsn )
Phase 3
1,651
qftzwovcnz(iiauzisyzp) = At Month-12, mean SDMT score changed minimally from Baseline for siponimod vs a 4.7-point worsening for placebo vsdiieiulc (cpvbtkuqre )
Positive
03 May 2022
Placebo
Phase 3
-
bvdbznjuot(qmugsjhzlk): HR = 0.77 (95% CI, 0.65 - 0.92), P-Value = 0.0047
Positive
05 Apr 2022
Placebo
Not Applicable
-
rsjoldjezn(msmhsayxkf) = typsqivxnv ffdkkeavxv (tlrnfkxltp )
-
12 Oct 2021
rsjoldjezn(msmhsayxkf) = ypewqsjkyw ffdkkeavxv (tlrnfkxltp )
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Regulation

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