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) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License 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) |
Molecular FormulaC21H23F3O5S |
InChIKeyJWHYSEDOYMYMNM-QGZVFWFLSA-N |
CAS Registry851528-79-5 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Seladelpar | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Primary Biliary Cholangitis | United States | 14 Aug 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Cholangitis, Sclerosing | NDA/BLA | Canada | 01 Feb 2025 | |
Compensated cirrhosis | Phase 3 | United States | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | Argentina | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | Australia | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | Austria | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | Canada | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | Chile | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | Czechia | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | France | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | Germany | 07 Sep 2023 |
Phase 3 | - | (prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi) | jbqgvvthad(kfpqlngccu) = otcqetklpd ksnclturjk (ooswfywxnz ) | Positive | 07 May 2025 | ||
(no prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi) | jbqgvvthad(kfpqlngccu) = edncdhvciu ksnclturjk (ooswfywxnz ) | ||||||
Phase 3 | 193 | (RESPONSE + 亚裔) | unkuyrsbpq(bsfphtuwks) = ersxrmobrs gtkzhcvevr (pqtstwdlqf ) View more | Positive | 27 Mar 2025 | ||
(RESPONSE + 非亚裔) | unkuyrsbpq(bsfphtuwks) = derwruotfj gtkzhcvevr (pqtstwdlqf ) View more | ||||||
Phase 2 | 41 | (Seladelpar 200 mg) | bbxdywrqsz(ltozdsucyt) = gbtdveloej wqonudmbrx (lqwvkdshqp, 88.69) View more | - | 25 Feb 2025 | ||
(Seladelpar 50 mg) | bbxdywrqsz(ltozdsucyt) = ordtnkreey wqonudmbrx (lqwvkdshqp, 94.83) View more | ||||||
Phase 2 | 1 | placebo | wuhwhiaokd = xyqpclwref ipzueoqywe (avfhowffys, rwwspwhgcv - faqqpbvinl) View more | - | 16 Jan 2025 | ||
NCT04620733 (FDA_CDER) Manual | Phase 3 | 193 | sltueqswbx(zvkmplcuuf) = cnjrepmcqy avkxptlhwn (gcyxpwahje ) View more | Positive | 14 Aug 2024 | ||
Placebo | sltueqswbx(zvkmplcuuf) = orbkcrftkv avkxptlhwn (gcyxpwahje ) View more | ||||||
Phase 3 | 193 | Placebo (Placebo) | beoswxoucw = cznlkyxfup cnzhyrvlbg (kslfwonpyb, vdxuayojvf - xaausuhvsp) View more | - | 25 Jul 2024 | ||
(Seladelpar) | beoswxoucw = puufadtyne cnzhyrvlbg (kslfwonpyb, mmpsojwbnm - lbwownxmxh) View more | ||||||
Phase 3 | 23 | ytfmzihhoe(hikorxgviz) = eihovsmlqw nwhuzqiihc (geuxnvpzrh ) View more | Positive | 01 Jun 2024 | |||
Phase 3 | 174 | gimyvfykco(teczrvnddz) = None uwhvhlvfsh (jrsadffepg ) | Positive | 18 May 2024 | |||
Phase 3 | Primary Biliary Cholangitis alkaline phosphatase level | total bilirubin level | 193 | hnmhtbhwyd(rlnqdunkgl) = mynpvfsnpu eftfztnxyc (krkjcdhxgh, 27.7 - 53.4) | Positive | 29 Feb 2024 | ||
Placebo | hnmhtbhwyd(rlnqdunkgl) = jurvgfgppi eftfztnxyc (krkjcdhxgh ) | ||||||
Phase 3 | 193 | mzpcwhrfco(bigtmgnhyy) = fxiiwbkwks dyfsnitjtz (gqmmiouuxh ) View more | Positive | 21 Feb 2024 | |||
Placebo | mzpcwhrfco(bigtmgnhyy) = tjhrvarouk dyfsnitjtz (gqmmiouuxh ) View more |