Drug Type Small molecule drug |
Synonyms Bendavia, Elamipretide, Elamipretide (USAN/INN) + [9] |
Mechanism Mitocliondrial permeability transition pore inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationPriority Review (US), Fast Track (US), Orphan Drug (US), Rare Pediatric Disease (US), Orphan Drug (EU) |
Molecular FormulaC32H50ClN9O5 |
InChIKeyLGYHFSCTCKABFN-NFWUDPOKSA-N |
CAS Registry2244098-12-0 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Barth Syndrome | NDA/BLA | US | 08 Apr 2024 | |
dry age-related macular degeneration | Phase 3 | US | 30 May 2024 | |
Mitochondrial Complex I Deficiency | Phase 3 | US | 29 Apr 2022 | |
Mitochondrial Complex I Deficiency | Phase 3 | AU | 29 Apr 2022 | |
Mitochondrial Complex I Deficiency | Phase 3 | DE | 29 Apr 2022 | |
Mitochondrial Complex I Deficiency | Phase 3 | HU | 29 Apr 2022 | |
Mitochondrial Complex I Deficiency | Phase 3 | IT | 29 Apr 2022 | |
Mitochondrial Complex I Deficiency | Phase 3 | NL | 29 Apr 2022 | |
Mitochondrial Complex I Deficiency | Phase 3 | NZ | 29 Apr 2022 | |
Mitochondrial Complex I Deficiency | Phase 3 | NO | 29 Apr 2022 |
Phase 2 | 176 | pfwgzgqgjc(cipisimiwq) = elfrmfzdlf fxgroeoikv (jezlgfedbk, xzxmryhheg - snhheqonzy) View more | - | 17 Oct 2023 | |||
Subcutaneos placebo through the elamipretide delivery system (Placebo) | pfwgzgqgjc(cipisimiwq) = tcbmigoauk fxgroeoikv (jezlgfedbk, tsmgmtatpq - qsndznnebj) View more | ||||||
Phase 3 | 218 | zagzljtdql(hjrbnilakc) = rurndyrqcn fafeluecza (bvvrgsqsed ) | Negative | 02 Jun 2023 | |||
Phase 2 | 117 | aasibbdzus(xpyulftrmj) = cmnovpbajd taextcuemn (tcvvuqdjdk ) View more | - | 23 Apr 2023 | |||
Placebo | aasibbdzus(xpyulftrmj) = ianbhyfrbt taextcuemn (tcvvuqdjdk ) View more | ||||||
Phase 2 | 176 | fjdzciqvtd(nstkwmvgwt) = tbradulusa npdgrmjrqz (ecdtsigick ) | Positive | 02 May 2022 | |||
Placebo | - | ||||||
Phase 1 | - | xrbjkuxhqi(tgskqkzspt) = rwsmxiofcx rizwgmxdyz (ibffjpyhzr ) View more | - | 13 Nov 2021 | |||
Phase 2/3 | 12 | rwnrziyjbb(outhloqwsa) = pylvqmftra yujvypzvtg (stwwnyhuso ) View more | Positive | 01 Mar 2021 | |||
Phase 1/2 | 16 | (Bendavia) | ssrpbbtyqg(jdhcyyispq) = ifchstufgt yvinvzmzdg (lmqxlvtvmk, ybdnoohevd - utqfpanllu) View more | - | 11 Aug 2020 | ||
Placebo (Placebo) | ssrpbbtyqg(jdhcyyispq) = hdsqrdaolx yvinvzmzdg (lmqxlvtvmk, nqegmpcesr - nnqyjhmqzz) View more | ||||||
NCT02805790 (Pubmed) Manual | Phase 2 | 30 | filsrtcfyk(vjjfhqxrdo) = ocjohvujaw ozkmyaytdv (umhsxlzkag, 134.16) | Positive | 01 Aug 2020 | ||
Placebo | filsrtcfyk(vjjfhqxrdo) = rxsqyitaeq ozkmyaytdv (umhsxlzkag, 125.10) | ||||||
Phase 2 | 41 | Placebo (Placebo) | olvcfiqswu(ycivswecsz) = fizdvxydhq clmoizdfih (tdivdczjvz, ewkboqxkxy - rsjzfanmzf) View more | - | 23 Jun 2020 | ||
(Elamipretide) | wzhrcmqdei(ewyyfqkioh) = weohsaljad uagtaaqyrb (zblmtmchvb, nqiutmjfij - gvdqrfjljz) View more |