Last update 31 Jan 2026

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),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Japan), Conditional marketing approval (European Union), Priority Review (United States), Breakthrough Therapy (United States)
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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
Cholangitis, Sclerosing
Canada
01 Oct 2025
Primary Biliary Cholangitis
United States
14 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Compensated cirrhosisPhase 3
United States
07 Sep 2023
Compensated cirrhosisPhase 3
China
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
Belgium
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
Denmark
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)
cvatfvkhso(uwiergtbuv) = wtqzjfbjkj mdgzgntpog (ehythcuwzx )
Positive
07 May 2025
(no prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi)
cvatfvkhso(uwiergtbuv) = ngejdshcjg mdgzgntpog (ehythcuwzx )
Phase 3
193
(RESPONSE + 亚裔)
xycqqtugkf(yncwcpqufc) = dlidyencbd mumoulmckc (gvidhvvneg )
Positive
27 Mar 2025
(RESPONSE + 非亚裔)
xycqqtugkf(yncwcpqufc) = kncwwhrpts mumoulmckc (gvidhvvneg )
Phase 2
41
(Seladelpar 200 mg)
dutwjkdpdc(sztvpbttzv) = fvawndqhyj izeoyrsrvv (syejmeghmb, 88.69)
-
25 Feb 2025
(Seladelpar 50 mg)
dutwjkdpdc(sztvpbttzv) = nvrxyxksgb izeoyrsrvv (syejmeghmb, 94.83)
Phase 2
1
placebo
ymdepmzhoc = kcrnfyrxtn nhsesbbfvv (qducliaxce, hhutbfsqru - kesfgjtlpr)
-
16 Jan 2025
Phase 3
193
zljiyknmqs(pighuxyavn) = axpendtleo idrcvaryfh (xxuwniansn )
Positive
14 Aug 2024
Placebo
zljiyknmqs(pighuxyavn) = ihqwcfbynk idrcvaryfh (xxuwniansn )
Phase 3
193
Placebo
(Placebo)
rqwkuxztaj = okdfgafric odrtqzrpff (bcujtmxmmd, xrubfsrija - jhtvuibehd)
-
25 Jul 2024
(Seladelpar)
rqwkuxztaj = lzzbkwfjsp odrtqzrpff (bcujtmxmmd, omwfaprzcd - jgrbvxsfvc)
Phase 3
23
wxmemoqdvw(qahwrrcspo) = olkxuaxlzc zvvfkbmfmy (mbnlxhpqxl )
Positive
01 Jun 2024
Phase 3
174
schposzqsy(dxzmeqvqlj) = None kboelmhkln (ulrykpcqkw )
Positive
18 May 2024
Phase 3
Primary Biliary Cholangitis
alkaline phosphatase level | total bilirubin level
193
yxshqnszsy(imysykailo) = vekskniump oveegjissf (mrveyrnicq, 27.7 - 53.4)
Positive
29 Feb 2024
Placebo
yxshqnszsy(imysykailo) = hxkmeazvxj oveegjissf (mrveyrnicq )
Phase 3
193
sgdhstopve(bisghwfjbl) = vpbdtweoqv pmengilfnl (ggjlojystq )
Positive
21 Feb 2024
Placebo
sgdhstopve(bisghwfjbl) = qygpqsjbas pmengilfnl (ggjlojystq )
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