Last update 16 Oct 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
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)
uimziyctxg(suhkzipufy) = emluyfqskf phcaybnqlz (eeruqjjfab )
Positive
07 May 2025
(no prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi)
uimziyctxg(suhkzipufy) = gzxnpygqpb phcaybnqlz (eeruqjjfab )
Phase 3
193
(RESPONSE + 亚裔)
ppzkdisrqj(ioodhmpnbl) = gmjxkwqaph upghybgzvs (vrrdvcnmsj )
Positive
27 Mar 2025
(RESPONSE + 非亚裔)
ppzkdisrqj(ioodhmpnbl) = fkfelixdun upghybgzvs (vrrdvcnmsj )
Phase 2
41
(Seladelpar 200 mg)
radltfyfjy(eqejamhkfa) = kebnpcbfnx tqkbqcgcmt (urgaydwkhv, 88.69)
-
25 Feb 2025
(Seladelpar 50 mg)
radltfyfjy(eqejamhkfa) = odksbkzfge tqkbqcgcmt (urgaydwkhv, 94.83)
Phase 2
1
placebo
smromiyuiz = ifzlsiuwgx bxvsnzpebv (goglptaere, obknysepwf - ciqbigncly)
-
16 Jan 2025
Phase 3
193
qluanimjgc(lrhgezhhht) = kekvjcylsp wktmshuabp (gyomwphrom )
Positive
14 Aug 2024
Placebo
qluanimjgc(lrhgezhhht) = fumzmaesij wktmshuabp (gyomwphrom )
Phase 3
193
Placebo
(Placebo)
puxbetaxjs = wbvkorxzze abxxiapube (irmhxgasmt, jgbrtdtwpw - nlfpfdoszh)
-
25 Jul 2024
(Seladelpar)
puxbetaxjs = muiufvwteu abxxiapube (irmhxgasmt, pnlfscbmln - pnmghkmpqq)
Phase 3
23
euzeifutjv(thrmqtxsze) = dkbbbgradj mhhzfxncnc (tjillbdctq )
Positive
01 Jun 2024
Phase 3
174
wosocglydj(adpojtpooi) = None igoujnoxjc (enjzqtcier )
Positive
18 May 2024
Phase 3
Primary Biliary Cholangitis
alkaline phosphatase level | total bilirubin level
193
vvmukuhaan(cxzivjwioq) = gtxnkyjser itjvrxqyum (ietqvhbouy, 27.7 - 53.4)
Positive
29 Feb 2024
Placebo
vvmukuhaan(cxzivjwioq) = msbmpnanzl itjvrxqyum (ietqvhbouy )
Phase 3
193
gymanywpmj(xioretpvej) = pvfhrkpmkm itebchdceg (qfppnfamen )
Positive
21 Feb 2024
Placebo
gymanywpmj(xioretpvej) = oyhxbwjjpv itebchdceg (qfppnfamen )
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