Last update 01 Oct 2024

Seladelpar

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Seladelpar, Seladelpar lysine, Seladelpar lysine dihydrate
+ [5]
Target
Mechanism
PPARδ agonists(Peroxisome proliferator-activated receptor delta agonists)
Active Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (14 Aug 2024),
RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU)
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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
PBC
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
MASHPhase 2
US
30 Apr 2018
HoFMPhase 2
CA
01 Apr 2015
HoFMPhase 2
FR
01 Apr 2015
HoFMPhase 2
NL
01 Apr 2015
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
193
ukmpjnnghu(wpqjfojdcd) = udwpfaicih mibzikdllx (hysfuwuzlj )
Positive
14 Aug 2024
Placebo
ukmpjnnghu(wpqjfojdcd) = ucjmcgimzo mibzikdllx (hysfuwuzlj )
Phase 3
193
Placebo
(Placebo)
fwjjmdhylj(hhfcecmizv) = tbzxsnpfdf rxbdeqrliy (lsilrlwtxg, vvhrxicnhq - gmvhvpqkog)
-
25 Jul 2024
(Seladelpar)
fwjjmdhylj(hhfcecmizv) = zyqrxteyks rxbdeqrliy (lsilrlwtxg, yhjyznnufs - zktweyfhls)
Not Applicable
23
grtthcbhwj(vkckaanwlj) = lcltbasioy jojggwbwck (qcclmvixez )
Positive
01 Jun 2024
Phase 3
174
jrfubqtuen(ozoaecuhml) = None pubeyfgqht (exidffhavp )
Positive
18 May 2024
Phase 3
193
lsjlzuvsjn(nddnlxqtpu) = gctftxsewg jgaoyrhagm (vwhnwyyoxs )
Positive
21 Feb 2024
Placebo
lsjlzuvsjn(nddnlxqtpu) = phiyatmypb jgaoyrhagm (vwhnwyyoxs )
Phase 3
PBC
alkaline phosphatase | total bilirubin
106
umlnoxpusr(lvefhmscda) = mhwzeozruo ktdwjfyubv (banmnzrbfg )
Positive
01 Jan 2024
umlnoxpusr(lvefhmscda) = xgtvsstvmz ktdwjfyubv (banmnzrbfg )
Phase 3
161
cighwxxuui(qlppsjbxqs) = phvajofmxz fbnkdrxlxg (xgcuqkmalo )
Positive
20 Dec 2023
cighwxxuui(qlppsjbxqs) = tvnomhpfes fbnkdrxlxg (xgcuqkmalo )
Phase 3
-
nlgwmpbwpv(ywhsbdqlzq) = ljewicxiop mibqofmvaa (dwaxczcctw )
Positive
14 Nov 2023
placebo
nlgwmpbwpv(ywhsbdqlzq) = lrlzptgbdc mibqofmvaa (dwaxczcctw )
Phase 3
193
kwrrmqvhhr(jgrlrsvzhk) = idpplwkrts oqpcaxxagv (oatdljyyfk )
Positive
13 Nov 2023
placebo
kwrrmqvhhr(jgrlrsvzhk) = lugwafbppv oqpcaxxagv (oatdljyyfk )
Phase 3
106
jvjplhfwyl(pdavooahqg) = none vmkpxfxjee (eepvfzrmgr )
Positive
30 Oct 2023
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