Drug Type Small molecule drug |
Synonyms Seladelpar, Seladelpar lysine, Seladelpar lysine dihydrate + [5] |
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), |
RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU) |
Molecular FormulaC21H23F3O5S |
InChIKeyJWHYSEDOYMYMNM-QGZVFWFLSA-N |
CAS Registry851528-79-5 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Seladelpar | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
PBC | US | 14 Aug 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Compensated cirrhosis | Phase 3 | US | 07 Sep 2023 | |
Compensated cirrhosis | Phase 3 | KR | 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 | |
MASH | Phase 2 | US | 30 Apr 2018 | |
HoFM | Phase 2 | CA | 01 Apr 2015 | |
HoFM | Phase 2 | FR | 01 Apr 2015 | |
HoFM | Phase 2 | NL | 01 Apr 2015 |
NCT04620733 (FDA_CDER) Manual | Phase 3 | 193 | ukmpjnnghu(wpqjfojdcd) = udwpfaicih mibzikdllx (hysfuwuzlj ) View more | Positive | 14 Aug 2024 | ||
Placebo | ukmpjnnghu(wpqjfojdcd) = ucjmcgimzo mibzikdllx (hysfuwuzlj ) View more | ||||||
Phase 3 | 193 | Placebo (Placebo) | fwjjmdhylj(hhfcecmizv) = tbzxsnpfdf rxbdeqrliy (lsilrlwtxg, vvhrxicnhq - gmvhvpqkog) View more | - | 25 Jul 2024 | ||
(Seladelpar) | fwjjmdhylj(hhfcecmizv) = zyqrxteyks rxbdeqrliy (lsilrlwtxg, yhjyznnufs - zktweyfhls) View more | ||||||
Not Applicable | 23 | grtthcbhwj(vkckaanwlj) = lcltbasioy jojggwbwck (qcclmvixez ) View more | Positive | 01 Jun 2024 | |||
Phase 3 | 174 | jrfubqtuen(ozoaecuhml) = None pubeyfgqht (exidffhavp ) | Positive | 18 May 2024 | |||
Phase 3 | 193 | lsjlzuvsjn(nddnlxqtpu) = gctftxsewg jgaoyrhagm (vwhnwyyoxs ) View more | Positive | 21 Feb 2024 | |||
Placebo | lsjlzuvsjn(nddnlxqtpu) = phiyatmypb jgaoyrhagm (vwhnwyyoxs ) View more | ||||||
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 | Seladelpar 5 mg | cighwxxuui(qlppsjbxqs) = phvajofmxz fbnkdrxlxg (xgcuqkmalo ) | Positive | 20 Dec 2023 | ||
Seladelpar 10 mg | cighwxxuui(qlppsjbxqs) = tvnomhpfes fbnkdrxlxg (xgcuqkmalo ) | ||||||
RESPONSE (NEWS) Manual | Phase 3 | - | nlgwmpbwpv(ywhsbdqlzq) = ljewicxiop mibqofmvaa (dwaxczcctw ) View more | Positive | 14 Nov 2023 | ||
placebo | nlgwmpbwpv(ywhsbdqlzq) = lrlzptgbdc mibqofmvaa (dwaxczcctw ) View more | ||||||
RESPONSE (PRNewswire) Manual | Phase 3 | 193 | kwrrmqvhhr(jgrlrsvzhk) = idpplwkrts oqpcaxxagv (oatdljyyfk ) View more | Positive | 13 Nov 2023 | ||
placebo | kwrrmqvhhr(jgrlrsvzhk) = lugwafbppv oqpcaxxagv (oatdljyyfk ) View more | ||||||
NCT03301506 (Literature) Manual | Phase 3 | 106 | jvjplhfwyl(pdavooahqg) = none vmkpxfxjee (eepvfzrmgr ) View more | Positive | 30 Oct 2023 |