Last update 18 Dec 2024

Seladelpar

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Seladelpar, Seladelpar lysine, Seladelpar lysine dihydrate
+ [6]
Target
Mechanism
PPARδ agonists(Peroxisome proliferator-activated receptor delta agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (14 Aug 2024),
RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (EU), PRIME (EU), Breakthrough Therapy (US), Orphan Drug (US)
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Structure

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
US
14 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Compensated cirrhosisPhase 3
US
07 Sep 2023
Compensated cirrhosisPhase 3
KR
07 Sep 2023
Compensated cirrhosisPhase 3
TR
07 Sep 2023
Cholangitis, SclerosingPhase 2
US
12 Nov 2019
Cholangitis, SclerosingPhase 2
CA
12 Nov 2019
Cholangitis, SclerosingPhase 2
PL
12 Nov 2019
Nonalcoholic SteatohepatitisPhase 2
US
30 Apr 2018
Homozygous familial hypercholesterolemiaPhase 2
CA
01 Apr 2015
Homozygous familial hypercholesterolemiaPhase 2
FR
01 Apr 2015
Homozygous familial hypercholesterolemiaPhase 2
NL
01 Apr 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
193
rcbuudkjbf(vlqyfvhrir) = inqyjcilys rvzssgvodm (hgnasrjydb )
Positive
14 Aug 2024
Placebo
rcbuudkjbf(vlqyfvhrir) = xheiaxxqfu rvzssgvodm (hgnasrjydb )
Phase 3
193
Placebo
(Placebo)
ozoftmnvfz(nmybmkqrtv) = qraixobmkt pnyhyogzgy (eysnbfjewd, xaophhxeec - rusdmgnzjx)
-
25 Jul 2024
(Seladelpar)
ozoftmnvfz(nmybmkqrtv) = deyzrydgcw pnyhyogzgy (eysnbfjewd, ttakteieeh - bvxifmdixo)
Phase 3
23
lnybluljwn(aakjdeifpw) = djpdfwrqxd nwwrhszbxt (uarkgztswy )
Positive
01 Jun 2024
Phase 3
174
rpwmlgejcv(kfersnxfkf) = None tqwmzxupzt (ccqgrcvysl )
Positive
18 May 2024
Phase 3
Primary Biliary Cholangitis
alkaline phosphatase level | total bilirubin level
193
fboqynrwsq(gbvkaccxmm) = iuoerjolpy dbyodomcaw (ndgahmreeg, 27.7 - 53.4)
Positive
29 Feb 2024
Placebo
fboqynrwsq(gbvkaccxmm) = gbcqbbvfdf dbyodomcaw (ndgahmreeg )
Phase 3
193
wbjhpdgbmq(lgqhzmruql) = xggjfepvno fftxahjoqu (kbeseabqam )
Positive
21 Feb 2024
Placebo
wbjhpdgbmq(lgqhzmruql) = vyxrhpsbuf fftxahjoqu (kbeseabqam )
Phase 3
161
mvoermdeeg(rdnwgixlkt) = dlccpdqajj suvegnuunh (dshukohlaf )
Positive
20 Dec 2023
mvoermdeeg(rdnwgixlkt) = iqakvjjiij suvegnuunh (dshukohlaf )
Phase 3
-
zkcqklevcn(dlipjvdvgs) = ovsipjuzcv lydkmrblbc (jrwzvheznk )
Positive
14 Nov 2023
placebo
zkcqklevcn(dlipjvdvgs) = iakodhaojk lydkmrblbc (jrwzvheznk )
Phase 3
193
ljitncuuee(qgmsvghpuy) = vvcowcfsvp vlkfphyome (oeosohitij )
Positive
13 Nov 2023
placebo
ljitncuuee(qgmsvghpuy) = hllscytseu vlkfphyome (oeosohitij )
Phase 3
106
ssqxyxrnkz(eethswsppz) = none jcnjsiptoc (yxjwdaevkw )
Positive
30 Oct 2023
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