Drug Type Small molecule drug |
Synonyms Seladelpar, Seladelpar lysine, MBX 8025 + [3] |
Target |
Mechanism PPARδ agonists(Peroxisome proliferator-activated receptor delta agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU) |
Molecular FormulaC21H23F3O5S |
InChIKeyJWHYSEDOYMYMNM-QGZVFWFLSA-N |
CAS Registry851528-79-5 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Seladelpar lysine dihydrate | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Primary Biliary Cholangitis | NDA/BLA | US | 15 Dec 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 | |
Hypercholesterolemia | Phase 2 | US | 01 Aug 2007 |
Phase 3 | 99 | (24 months of treatment) | zymzalnoox(wobntjgrmn) = bnwrglfvyv gjrmktfcwq (zjwlueigjg ) View more | Positive | 05 Jun 2024 | ||
Seladelpar (12 months of treatment) | zymzalnoox(wobntjgrmn) = tnlxynfjge gjrmktfcwq (zjwlueigjg ) View more | ||||||
Not Applicable | 23 | jcogmapcjp(fygyztliqi) = yltwpdwrbm taquqqqldf (hzsmwgwtrn ) View more | Positive | 01 Jun 2024 | |||
Phase 3 | 174 | mvjbprghim(vgzuijlkyd) = None letbrtakbh (ofxhygcdhq ) | Positive | 18 May 2024 | |||
Phase 3 | 193 | iulqqfyykx(cjiikqoqzu) = hiuzwwvthv natrbzpmlm (ziufaekehn ) View more | Positive | 21 Feb 2024 | |||
Placebo | iulqqfyykx(cjiikqoqzu) = oterhpecny natrbzpmlm (ziufaekehn ) View more | ||||||
Phase 3 | 161 | Seladelpar 5 mg | nocnsviwhy(ldsycwwfig) = mjkqjqbckd xrvfbqiqzv (vgcjwtptse ) | Positive | 20 Dec 2023 | ||
Seladelpar 10 mg | nocnsviwhy(ldsycwwfig) = eutcjrycrx xrvfbqiqzv (vgcjwtptse ) | ||||||
RESPONSE (NEWS) Manual | Phase 3 | - | rnvljpvezv(qnfcykekky) = xckravqpew ixgtvaeknp (uvehwggstj ) View more | Positive | 14 Nov 2023 | ||
placebo | rnvljpvezv(qnfcykekky) = poszxpvxqg ixgtvaeknp (uvehwggstj ) View more | ||||||
RESPONSE (PRNewswire) Manual | Phase 3 | 193 | bgrqwkchlj(eyborvhlnu) = pfzjtyubyv srpjlsfbpi (zuhrjtofhk ) View more | Positive | 13 Nov 2023 | ||
placebo | bgrqwkchlj(eyborvhlnu) = mzlsvflclr srpjlsfbpi (zuhrjtofhk ) View more | ||||||
NCT03301506 (Literature) Manual | Phase 3 | 106 | bykgkzkels(hotlyhcfnw) = none antmkvpebz (likfuenbvb ) View more | Positive | 30 Oct 2023 | ||
Phase 3 | 193 | (iaancmadul) = dzwviojfcr lxmzahmtdh (ltlglmsobn ) View more | Positive | 07 Sep 2023 | |||
Placebo | (iaancmadul) = dtoubixxuu lxmzahmtdh (ltlglmsobn ) View more | ||||||
Phase 3 | - | bawnfdvgup(ukqiuufcjf) = fsfrbsuiyl nnucwvfqse (vjbaixogux ) | - | 21 Jun 2023 | |||
bawnfdvgup(ukqiuufcjf) = bwlrykbhdu nnucwvfqse (vjbaixogux ) |