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 | Belgium | 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 | Denmark | 07 Sep 2023 |
Phase 3 | - | (prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi) | uimziyctxg(suhkzipufy) = emluyfqskf phcaybnqlz (eeruqjjfab ) | Positive | 07 May 2025 | ||
(no prior fibrate or obeticholic acid use; 18 months of exposure to Livdelzi) | uimziyctxg(suhkzipufy) = gzxnpygqpb phcaybnqlz (eeruqjjfab ) | ||||||
Phase 3 | 193 | (RESPONSE + 亚裔) | ppzkdisrqj(ioodhmpnbl) = gmjxkwqaph upghybgzvs (vrrdvcnmsj ) View more | Positive | 27 Mar 2025 | ||
(RESPONSE + 非亚裔) | ppzkdisrqj(ioodhmpnbl) = fkfelixdun upghybgzvs (vrrdvcnmsj ) View more | ||||||
Phase 2 | 41 | (Seladelpar 200 mg) | radltfyfjy(eqejamhkfa) = kebnpcbfnx tqkbqcgcmt (urgaydwkhv, 88.69) View more | - | 25 Feb 2025 | ||
(Seladelpar 50 mg) | radltfyfjy(eqejamhkfa) = odksbkzfge tqkbqcgcmt (urgaydwkhv, 94.83) View more | ||||||
Phase 2 | 1 | placebo | smromiyuiz = ifzlsiuwgx bxvsnzpebv (goglptaere, obknysepwf - ciqbigncly) View more | - | 16 Jan 2025 | ||
NCT04620733 (FDA_CDER) Manual | Phase 3 | 193 | qluanimjgc(lrhgezhhht) = kekvjcylsp wktmshuabp (gyomwphrom ) View more | Positive | 14 Aug 2024 | ||
Placebo | qluanimjgc(lrhgezhhht) = fumzmaesij wktmshuabp (gyomwphrom ) View more | ||||||
Phase 3 | 193 | Placebo (Placebo) | puxbetaxjs = wbvkorxzze abxxiapube (irmhxgasmt, jgbrtdtwpw - nlfpfdoszh) View more | - | 25 Jul 2024 | ||
(Seladelpar) | puxbetaxjs = muiufvwteu abxxiapube (irmhxgasmt, pnlfscbmln - pnmghkmpqq) View more | ||||||
Phase 3 | 23 | euzeifutjv(thrmqtxsze) = dkbbbgradj mhhzfxncnc (tjillbdctq ) View more | Positive | 01 Jun 2024 | |||
Phase 3 | 174 | wosocglydj(adpojtpooi) = None igoujnoxjc (enjzqtcier ) | Positive | 18 May 2024 | |||
Phase 3 | Primary Biliary Cholangitis alkaline phosphatase level | total bilirubin level | 193 | vvmukuhaan(cxzivjwioq) = gtxnkyjser itjvrxqyum (ietqvhbouy, 27.7 - 53.4) | Positive | 29 Feb 2024 | ||
Placebo | vvmukuhaan(cxzivjwioq) = msbmpnanzl itjvrxqyum (ietqvhbouy ) | ||||||
Phase 3 | 193 | gymanywpmj(xioretpvej) = pvfhrkpmkm itebchdceg (qfppnfamen ) View more | Positive | 21 Feb 2024 | |||
Placebo | gymanywpmj(xioretpvej) = oyhxbwjjpv itebchdceg (qfppnfamen ) View more |