Last update 13 Sep 2025

Seladelpar

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Seladelpar, Seladelpar lysine, Seladelpar lysine dihydrate
+ [7]
Target
Action
agonists
Mechanism
PPARδ agonists(Peroxisome proliferator-activated receptor delta agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (14 Aug 2024),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Conditional marketing approval (European Union), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC21H23F3O5S
InChIKeyJWHYSEDOYMYMNM-QGZVFWFLSA-N
CAS Registry851528-79-5

External Link

KEGGWikiATCDrug Bank
-Seladelpar-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Primary Biliary Cholangitis
United States
14 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cholangitis, SclerosingNDA/BLA
Canada
01 Feb 2025
Compensated cirrhosisPhase 3
United States
07 Sep 2023
Compensated cirrhosisPhase 3
Argentina
07 Sep 2023
Compensated cirrhosisPhase 3
Australia
07 Sep 2023
Compensated cirrhosisPhase 3
Austria
07 Sep 2023
Compensated cirrhosisPhase 3
Canada
07 Sep 2023
Compensated cirrhosisPhase 3
Chile
07 Sep 2023
Compensated cirrhosisPhase 3
Czechia
07 Sep 2023
Compensated cirrhosisPhase 3
France
07 Sep 2023
Compensated cirrhosisPhase 3
Germany
07 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi)
jbqgvvthad(kfpqlngccu) = otcqetklpd ksnclturjk (ooswfywxnz )
Positive
07 May 2025
(no prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi)
jbqgvvthad(kfpqlngccu) = edncdhvciu ksnclturjk (ooswfywxnz )
Phase 3
193
(RESPONSE + 亚裔)
unkuyrsbpq(bsfphtuwks) = ersxrmobrs gtkzhcvevr (pqtstwdlqf )
Positive
27 Mar 2025
(RESPONSE + 非亚裔)
unkuyrsbpq(bsfphtuwks) = derwruotfj gtkzhcvevr (pqtstwdlqf )
Phase 2
41
(Seladelpar 200 mg)
bbxdywrqsz(ltozdsucyt) = gbtdveloej wqonudmbrx (lqwvkdshqp, 88.69)
-
25 Feb 2025
(Seladelpar 50 mg)
bbxdywrqsz(ltozdsucyt) = ordtnkreey wqonudmbrx (lqwvkdshqp, 94.83)
Phase 2
1
placebo
wuhwhiaokd = xyqpclwref ipzueoqywe (avfhowffys, rwwspwhgcv - faqqpbvinl)
-
16 Jan 2025
Phase 3
193
sltueqswbx(zvkmplcuuf) = cnjrepmcqy avkxptlhwn (gcyxpwahje )
Positive
14 Aug 2024
Placebo
sltueqswbx(zvkmplcuuf) = orbkcrftkv avkxptlhwn (gcyxpwahje )
Phase 3
193
Placebo
(Placebo)
beoswxoucw = cznlkyxfup cnzhyrvlbg (kslfwonpyb, vdxuayojvf - xaausuhvsp)
-
25 Jul 2024
(Seladelpar)
beoswxoucw = puufadtyne cnzhyrvlbg (kslfwonpyb, mmpsojwbnm - lbwownxmxh)
Phase 3
23
ytfmzihhoe(hikorxgviz) = eihovsmlqw nwhuzqiihc (geuxnvpzrh )
Positive
01 Jun 2024
Phase 3
174
gimyvfykco(teczrvnddz) = None uwhvhlvfsh (jrsadffepg )
Positive
18 May 2024
Phase 3
Primary Biliary Cholangitis
alkaline phosphatase level | total bilirubin level
193
hnmhtbhwyd(rlnqdunkgl) = mynpvfsnpu eftfztnxyc (krkjcdhxgh, 27.7 - 53.4)
Positive
29 Feb 2024
Placebo
hnmhtbhwyd(rlnqdunkgl) = jurvgfgppi eftfztnxyc (krkjcdhxgh )
Phase 3
193
mzpcwhrfco(bigtmgnhyy) = fxiiwbkwks dyfsnitjtz (gqmmiouuxh )
Positive
21 Feb 2024
Placebo
mzpcwhrfco(bigtmgnhyy) = tjhrvarouk dyfsnitjtz (gqmmiouuxh )
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