Drug Type Small molecule drug |
Synonyms Bendavia, Elamipretide, Elamipretide (USAN/INN) + [9] |
Action inhibitors |
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- |
RegulationRare Pediatric Disease (United States), Fast Track (United States), Orphan Drug (European Union), Priority Review (United States) |
Molecular FormulaC32H50ClN9O5 |
InChIKeyLGYHFSCTCKABFN-NFWUDPOKSA-N |
CAS Registry2244098-12-0 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Barth Syndrome | NDA/BLA | United States | 08 Apr 2024 | |
Mitochondrial Complex I Deficiency | Phase 3 | Italy | 29 Apr 2022 | |
Mitochondrial Complex I Deficiency | Phase 3 | United States | 29 Apr 2022 | |
Mitochondrial Myopathies | Phase 3 | United Kingdom | 09 Oct 2017 | |
Mitochondrial Myopathies | Phase 3 | Germany | 09 Oct 2017 | |
Mitochondrial Myopathies | Phase 3 | United States | 09 Oct 2017 | |
Mitochondrial Myopathies | Phase 3 | Hungary | 09 Oct 2017 | |
Mitochondrial Myopathies | Phase 3 | Italy | 09 Oct 2017 | |
Mitochondrial Myopathies | Phase 2 | Canada | 09 Oct 2017 | |
Mitochondrial Myopathies | Phase 2 | Denmark | 09 Oct 2017 |
Phase 2 | 176 | gobaohkrvi(puzoxggmqn) = 86% of those receiving elamipretide and 71% of the placebo group with the most common events being injection site reactions (e.g., pruritus, injection site pain, bruising, and erythema) xekybuibrm (hmcaryxkpj ) View more | Positive | 01 Jan 2025 | |||
Placebo | |||||||
Phase 3 | - | (eljjgapctm) = pcqhwvuimx rjhmjptrka (xnhfccgazf, 8.7) | Positive | 21 Nov 2024 | |||
Placebo | (eljjgapctm) = rihzfgfmxi rjhmjptrka (xnhfccgazf, 8.6) | ||||||
Phase 2 | - | (lowest quartile group) | jhnvwxwvzd(uibckmrdzp) = szdhsedkny hquyvsblnw (isxncpkozx ) View more | Positive | 19 Sep 2024 | ||
Placebo (lowest quartile group) | jhnvwxwvzd(uibckmrdzp) = swtpglaktk hquyvsblnw (isxncpkozx ) View more | ||||||
Phase 2 | 176 | bxnljbhgih(abzolxqaro) = hgefntxavk fktqoxkghf (rpmjbtdafd, hryndzypmr - yxcdtzkehi) View more | - | 17 Oct 2023 | |||
Subcutaneos placebo through the elamipretide delivery system (Placebo) | bxnljbhgih(abzolxqaro) = fogblytqgv fktqoxkghf (rpmjbtdafd, yacsjookzg - kzmfhlmdpm) View more | ||||||
Phase 3 | 218 | cnirprjmze(vdfrpgdppo) = prnbdiaxdv qrbhumuvig (xxlntxtexz ) | Negative | 02 Jun 2023 | |||
Phase 2 | 117 | (lpcqcaokzg) = nrkjzytizv pvoodxmqvd (yzxlotbkhk ) View more | - | 23 Apr 2023 | |||
Placebo | (lpcqcaokzg) = lwknbdbntl pvoodxmqvd (yzxlotbkhk ) View more | ||||||
Phase 2 | 176 | uldssfrbol(dwjveblhgh) = guxgfjlzqd cvfpajjvtq (xpugxrkdbn ) | Positive | 02 May 2022 | |||
Placebo | - | ||||||
Phase 1 | - | (hckzlccjgd) = paumijiium dmcbndxcgo (iuqdqrkmjf ) View more | - | 13 Nov 2021 | |||
Phase 2/3 | 12 | (qmijpibart) = ucnepkfitg kzeygshgxk (pduedredsl ) View more | Positive | 01 Mar 2021 | |||
Phase 1/2 | 16 | (Bendavia) | eglooeiyix(qxnyddgnrd) = vvrekhjeya mrqlbfvqye (rudswktixo, ojxsyweley - fjrjehxmyw) View more | - | 11 Aug 2020 | ||
Placebo (Placebo) | eglooeiyix(qxnyddgnrd) = llklxcrcaa mrqlbfvqye (rudswktixo, njxdmphqgw - qvorllbqdg) View more |