Last update 11 Aug 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),
RegulationBreakthrough Therapy (United States), Accelerated 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)
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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
337
afnrmsjvvr(hnsuiihdrk) = Seladelpar was well tolerated, with overall AEs reported in 83.2 patients per 100 patient-years in year 1 and 62.3 in year 4 qxtuclnkut (zlglpcyzab )
Positive
02 May 2026
Phase 3
-
(prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi)
bznlzrzwvc(tjedbnsxui) = gkdlhhnaft jyjrvejlsy (hklxeebkfm )
Positive
07 May 2025
(no prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi)
bznlzrzwvc(tjedbnsxui) = cittkrhood jyjrvejlsy (hklxeebkfm )
Phase 3
193
yuiqshwjns(awefshslha) = AEs were reported in 86.4% of patients with baseline ALP <350 U/L and 84.9% of patients with ALP ≥350 U/L, with similar proportions in the seladelpar vs placebo groups. fhkapheyih (gvlwtedkbs )
Positive
03 May 2025
Placebo
Not Applicable
428
fqxvfcsrah(adelxfbomy) = zzncimezde egbpkatpvp (zvhyzbohar )
Positive
03 May 2025
Phase 3
337
myxgmezgyy(dlddqrkapr) = cczukimzgr hihikpyioe (ucemsqflyw )
Positive
03 May 2025
Phase 3
193
jfpcarzfax(xngfqvutcp) = rdyeozhxsb hsiklahtjq (kdruljmwjx )
Positive
03 May 2025
Placebo
jfpcarzfax(xngfqvutcp) = ajysvqpyvb hsiklahtjq (kdruljmwjx )
Phase 2/3
1,019
fwlnxfowsl(ylmmetrbxv): Difference (Mean) = -39.7 (95.0% CI, -49.8 to -29.6), P-Value = < 0.001
Positive
03 May 2025
Placebo
Phase 3
193
(RESPONSE + 亚裔)
pcdhcgzljt(oeyblguanx) = jyklgrxbfp gtgkybvfxm (vflyzbzmxc )
Positive
27 Mar 2025
(RESPONSE + 非亚裔)
pcdhcgzljt(oeyblguanx) = scxaicjvlc gtgkybvfxm (vflyzbzmxc )
Phase 2
41
(Seladelpar 200 mg)
gbvdbryave(vkpwygwjpb) = juisamxssj qmmpiloxet (jcrrinyjri, 88.69)
-
25 Feb 2025
(Seladelpar 50 mg)
gbvdbryave(vkpwygwjpb) = pipobdgtvn qmmpiloxet (jcrrinyjri, 94.83)
Phase 2
1
placebo
cqhjubopuc = scfrwbpamk ctiqddsebt (dtlupkaiuj, easynhjcfq - hrpklenppr)
-
16 Jan 2025
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