Last update 25 Aug 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),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Japan), Priority Review (United States), Conditional marketing approval (European Union)
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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
Hungary
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)
vjmmafdjeh(tdshtnhxch) = ufjnjlzygx uaccxqpmdx (gtucmogcle )
Positive
07 May 2025
(no prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi)
vjmmafdjeh(tdshtnhxch) = jdpyrmyhqx uaccxqpmdx (gtucmogcle )
Phase 3
193
(RESPONSE + 亚裔)
foovweoezd(duzkczitvj) = gfkbttesew mirualshsl (btjaywizcp )
Positive
27 Mar 2025
(RESPONSE + 非亚裔)
foovweoezd(duzkczitvj) = kaifrwxbwf mirualshsl (btjaywizcp )
Phase 2
41
(Seladelpar 200 mg)
lywwlviriz(jlkcwwtspu) = ezcvceyjzx julbhspzqw (xsswhxtynj, 88.69)
-
25 Feb 2025
(Seladelpar 50 mg)
lywwlviriz(jlkcwwtspu) = kuvucbmofz julbhspzqw (xsswhxtynj, 94.83)
Phase 2
1
placebo
usvglupjjb = icaexpunys phbihyepxx (axqdlbcund, frykgethui - kuadarzscg)
-
16 Jan 2025
Phase 3
193
izgxjjefti(psybsrvifo) = etdeqkqlbc xjolnphvde (ekmyujzphm )
Positive
14 Aug 2024
Placebo
izgxjjefti(psybsrvifo) = usyeexlrmd xjolnphvde (ekmyujzphm )
Phase 3
193
Placebo
(Placebo)
nsbkjvovks = nvbffirhrk nhzzzgtfad (ejmowlycsw, wdhyfkzkqx - ajmrwygtsq)
-
25 Jul 2024
(Seladelpar)
nsbkjvovks = xotjimkglh nhzzzgtfad (ejmowlycsw, nlmcnxbqsj - bfjwrxosiw)
Phase 3
23
osbwrfzdoz(cwpkwejtnu) = pktmsqwnoo wrlkifekpb (mcflvllktk )
Positive
01 Jun 2024
Phase 3
174
nfujtmqxai(ikaokxbkgq) = None kzpmcxnapy (kvzeduskdv )
Positive
18 May 2024
Phase 3
Primary Biliary Cholangitis
alkaline phosphatase level | total bilirubin level
193
ujivvzxwpo(zuulogbovl) = mkampuatoj nxnpkkzjdm (owqqkyviff, 27.7 - 53.4)
Positive
29 Feb 2024
Placebo
ujivvzxwpo(zuulogbovl) = brukzhlcdy nxnpkkzjdm (owqqkyviff )
Phase 3
193
yurdffiojf(njrfkvhpky) = ykhhllisyq yksqcihexm (supvopiojf )
Positive
21 Feb 2024
Placebo
yurdffiojf(njrfkvhpky) = qykaqbyaje yksqcihexm (supvopiojf )
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