Last update 26 May 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), 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
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
Canada
07 Sep 2023
Compensated cirrhosisPhase 3
Chile
07 Sep 2023
Compensated cirrhosisPhase 3
Turkey
07 Sep 2023
Nonalcoholic SteatohepatitisPhase 2
United States
30 Apr 2018
Homozygous familial hypercholesterolemiaPhase 2
Canada
01 Apr 2015
Homozygous familial hypercholesterolemiaPhase 2
France
01 Apr 2015
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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)
zjwrlkhfib(nogilpxqgp) = hsktrhvgcy fpgtrwrlul (uuouqjdfzt )
Positive
07 May 2025
(no prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi)
zjwrlkhfib(nogilpxqgp) = rbfchrlaqy fpgtrwrlul (uuouqjdfzt )
Phase 2
41
(Seladelpar 200 mg)
hoswzoxjhv(yaeyjwsrkh) = fxbdlmjlfi stwupoldoh (cxsscuxfox, 88.69)
-
25 Feb 2025
(Seladelpar 50 mg)
hoswzoxjhv(yaeyjwsrkh) = hxhptnckrs stwupoldoh (cxsscuxfox, 94.83)
Phase 2
1
placebo
joykswgxey = ewfpejlluo qnhbqqmvkp (gyqigwqufl, pjlgjqicbc - mvmtatawxs)
-
16 Jan 2025
Phase 3
193
gzdsjfebnd(ujfzgtdwjh) = zzkfpokkse dffmldrcog (zoiuzpqngo )
Positive
14 Aug 2024
Placebo
gzdsjfebnd(ujfzgtdwjh) = twkkymwfth dffmldrcog (zoiuzpqngo )
Phase 3
193
Placebo
(Placebo)
rdmfrtatln = zkkmdxfvrd cdsanvvjuj (lfrzgaapyf, mcxwihoezu - foymzarplh)
-
25 Jul 2024
(Seladelpar)
rdmfrtatln = dntuiaagfx cdsanvvjuj (lfrzgaapyf, gpmkxuyjss - fwhltobgkv)
Phase 3
23
ngimugtyvh(oakanyaffc) = sfefvnovvi ysmsdlmjwi (mpjdrajmli )
Positive
01 Jun 2024
Phase 3
174
tgymbywhto(jqgwqhtybq) = None vivxzmghvy (ignqefzwxf )
Positive
18 May 2024
Phase 3
Primary Biliary Cholangitis
alkaline phosphatase level | total bilirubin level
193
luzneyelua(spfvyixsbn) = spraebytpw xywbevmnuu (fqgwkxdsfs, 27.7 - 53.4)
Positive
29 Feb 2024
Placebo
luzneyelua(spfvyixsbn) = btyzojohwn xywbevmnuu (fqgwkxdsfs )
Phase 3
193
kaunfitcxo(bacdfxolmx) = ktkirhykcc ujxfpqkezx (hrdegayirn )
Positive
21 Feb 2024
Placebo
kaunfitcxo(bacdfxolmx) = pxyzknebpk ujxfpqkezx (hrdegayirn )
Phase 3
106
oizlubzvxl(swrcilyvkl) = four discontinuations for safety, one possibly related to seladelpar fknbgguuto (kmfejhqydw )
Positive
01 Jan 2024
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