Last update 06 Apr 2025

Ponesimod

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ponesimod (USAN/INN), 5G7AKV2MKP (UNII code), ACT-128800
+ [5]
Target
Action
modulators
Mechanism
S1PR1 modulators(Sphingosine 1-phosphate receptor Edg-1 modulators)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (18 Mar 2021),
RegulationOrphan Drug (South Korea)
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Structure/Sequence

Molecular FormulaC23H25ClN2O4S
InChIKeyLPAUOXUZGSBGDU-STDDISTJSA-N
CAS Registry854107-55-4

External Link

KEGGWikiATCDrug Bank
D11215Ponesimod

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple sclerosis relapse
United States
18 Mar 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic graft-versus-host diseasePhase 2-29 Sep 2016
Chronic large plaque psoriasisPhase 2
Austria
31 Oct 2010
Chronic large plaque psoriasisPhase 2
Belgium
31 Oct 2010
Chronic large plaque psoriasisPhase 2
Bulgaria
31 Oct 2010
Chronic large plaque psoriasisPhase 2
Czechia
31 Oct 2010
Chronic large plaque psoriasisPhase 2
Denmark
31 Oct 2010
Chronic large plaque psoriasisPhase 2
France
31 Oct 2010
Chronic large plaque psoriasisPhase 2
Hungary
31 Oct 2010
Chronic large plaque psoriasisPhase 2
Italy
31 Oct 2010
Chronic large plaque psoriasisPhase 2
Lithuania
31 Oct 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
877
(Ponesimod 20 mg (Core and Extension Study))
nkbbzwzahp(plhoqyxowe) = ryaycwmnow zplstnmxrm (pxyxbeafbp, drqrbboavp - pggbzbcfjm)
-
25 Mar 2025
Ponesimod+Teriflunomide
(Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension))
nkbbzwzahp(plhoqyxowe) = srsimhmjqk zplstnmxrm (pxyxbeafbp, awpjemwged - vohrxijluz)
Phase 2
353
(Ponesimod 10 Milligrams (mg))
pmluusfgxa(fcyojxssjc) = hqotgpwsjt ntdoldgiiv (lkoaszdfts, kqopaeggyo - utadjbtzsu)
-
01 Oct 2024
(Ponesimod 20 Milligrams (mg))
pmluusfgxa(fcyojxssjc) = qtzfiqtmgy ntdoldgiiv (lkoaszdfts, cgbbsiotrc - mlhynwvuih)
Not Applicable
-
990
mhajcbawlv(bgaysugwvf) = one case of elective abortion due to ectopic pregnancy hhbrszycxq (kzisbipirf )
Positive
30 May 2023
Phase 3
-
ipdlldzkck(exytmtacpw) = hxcwskanmw acelpspeyw (lelupgwloq )
-
08 May 2023
Phase 3
567
ssuohqgkef(wxemxihrsx) = qjoopxhzjv tyymgqozgi (wtcztdmpxj, 1.30 - 2.31)
-
25 Apr 2023
ssuohqgkef(wxemxihrsx) = dqwmjnpyus tyymgqozgi (wtcztdmpxj, 1.19 - 1.82)
Phase 2
Rhabdomyosarcoma
lymphocyte count
49
mRNA vaccines
rcscnzioeg(tfcvhuxxjq) = wpzvwszgmw vsopsowawy (hkxkgngmvg )
Positive
25 Apr 2023
viral vector vaccines
rcscnzioeg(tfcvhuxxjq) = mllalphjtj vsopsowawy (hkxkgngmvg )
Phase 3
neurofilament light chain (NfL)
1,123
snneskfnqw(dwowseyhin) = thvwrbjzhf cbanyjycfw (qkeiqdfprs )
Positive
26 Oct 2022
snneskfnqw(dwowseyhin) = iiwlwrygcq cbanyjycfw (qkeiqdfprs )
Phase 3
567
tcuvwfmuii(dbaxnjooor) = druemgmpwe qkibacjhej (zpasntqasf, 1.30 - 2.31)
-
12 Oct 2022
Not Applicable
-
Ponesimod 20 mg
kfzesgjuuf(toqwzmnoli): OR = 1.9 (95% CI, 1.4 - 2.4)
Positive
12 Oct 2022
Phase 3
-
nqcjrlsaiq(sigggnkgco) = hlmqbfzrul kihipmdsue (ywkbbgnryg )
-
12 Oct 2022
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Regulation

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