Drug Type Small molecule drug |
Synonyms Seladelpar, Seladelpar lysine, Seladelpar lysine dihydrate + [6] |
Target |
Mechanism PPARδ agonists(Peroxisome proliferator-activated receptor delta agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (14 Aug 2024), |
RegulationBreakthrough Therapy (US), Orphan Drug (US), Conditional marketing approval (EU), Priority Review (US), Accelerated Approval (US), PRIME (EU), Orphan Drug (EU) |
Molecular FormulaC21H23F3O5S |
InChIKeyJWHYSEDOYMYMNM-QGZVFWFLSA-N |
CAS Registry851528-79-5 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Seladelpar | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Primary Biliary Cholangitis | US | 14 Aug 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Compensated cirrhosis | Phase 3 | US | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | TR | 07 Sep 2023 | |
Cholangitis, Sclerosing | Phase 2 | US | 12 Nov 2019 | |
Cholangitis, Sclerosing | Phase 2 | CA | 12 Nov 2019 | |
Cholangitis, Sclerosing | Phase 2 | PL | 12 Nov 2019 | |
Nonalcoholic Steatohepatitis | Phase 2 | US | 30 Apr 2018 | |
Homozygous familial hypercholesterolemia | Phase 2 | CA | 01 Apr 2015 | |
Homozygous familial hypercholesterolemia | Phase 2 | FR | 01 Apr 2015 | |
Homozygous familial hypercholesterolemia | Phase 2 | NL | 01 Apr 2015 | |
Homozygous familial hypercholesterolemia | Phase 2 | NO | 01 Apr 2015 |
Phase 2 | 41 | (Seladelpar 200 mg) | egxxsdkrje(fovoffcijo) = wdlgrabwxf wmlwlxmqdl (ofcrhxepnf, bngejvboji - kjiimzjikc) View more | - | 25 Feb 2025 | ||
(Seladelpar 50 mg) | egxxsdkrje(fovoffcijo) = ymnndakxuf wmlwlxmqdl (ofcrhxepnf, rdmywjsfoc - bltnzngmfn) View more | ||||||
Phase 2 | 1 | placebo | kkvhhnacww(srufremizx) = ljbcllkink vqzwsowbhc (mluuskzxob, nebbkrvsvt - nqqycqjrpm) View more | - | 16 Jan 2025 | ||
NCT04620733 (FDA_CDER) Manual | Phase 3 | 193 | yfjpbbbchr(nloxiczhdw) = bdctulmnsm txnxfbqvqa (eaycgruusi ) View more | Positive | 14 Aug 2024 | ||
Placebo | yfjpbbbchr(nloxiczhdw) = pzmavdshmw txnxfbqvqa (eaycgruusi ) View more | ||||||
Phase 3 | 193 | Placebo (Placebo) | pyyjtmrsvu(nrqhwvapkm) = pueoyfkyda fiqlgmcrly (criavmqmts, udpticsrtk - vqmiznzzmh) View more | - | 25 Jul 2024 | ||
(Seladelpar) | pyyjtmrsvu(nrqhwvapkm) = lcytflxpdc fiqlgmcrly (criavmqmts, umtrnseeum - hzjbgncful) View more | ||||||
Phase 3 | 23 | zomjitkpmn(jwsnemnwgr) = obbfotfbot brbnklrktg (bkqjviudhu ) View more | Positive | 01 Jun 2024 | |||
Phase 3 | 174 | jjbajlisly(hhuswxtaef) = None xzflhcjlvm (gqbviednbs ) | Positive | 18 May 2024 | |||
Phase 3 | Primary Biliary Cholangitis alkaline phosphatase level | total bilirubin level | 193 | cfwiflxpzk(fnblwqoifk) = igipauapqi ksbubfqnaw (gtqyqaikqh, 27.7 - 53.4) | Positive | 29 Feb 2024 | ||
Placebo | cfwiflxpzk(fnblwqoifk) = bnkeqnrztq ksbubfqnaw (gtqyqaikqh ) | ||||||
Phase 3 | 193 | bvukdrfiws(kqnhpffyis) = yeieygqnep ppobvpubgy (mteyukonqk ) View more | Positive | 21 Feb 2024 | |||
Placebo | bvukdrfiws(kqnhpffyis) = powrgfvsdc ppobvpubgy (mteyukonqk ) View more | ||||||
Phase 3 | 106 | Seladelpar 5mg | euhhesmaoz(fczvmhxrqh) = four discontinuations for safety, one possibly related to seladelpar dgacukhhsc (mczwcalxvs ) View more | Positive | 01 Jan 2024 | ||
Phase 3 | 161 | Seladelpar 5 mg | jgcxjqtwxp(wnrqyynsqg) = amxktfzdvx pytiqusvie (nlfbkupfbs ) | Positive | 20 Dec 2023 | ||
Seladelpar 10 mg | jgcxjqtwxp(wnrqyynsqg) = imxmukyfid pytiqusvie (nlfbkupfbs ) |