Last update 01 Jul 2024

Elamipretide Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Bendavia, Elamipretide, Elamipretide (USAN/INN)
+ [9]
Mechanism
Mitocliondrial permeability transition pore inhibitors
Originator 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)

Structure

Molecular FormulaC32H50ClN9O5
InChIKeyLGYHFSCTCKABFN-NFWUDPOKSA-N
CAS Registry2244098-12-0

External Link

KEGGWikiATCDrug Bank
D10925--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Barth SyndromeNDA/BLA
US
08 Apr 2024
dry age-related macular degenerationPhase 3
US
30 May 2024
Mitochondrial Complex I DeficiencyPhase 3
US
29 Apr 2022
Mitochondrial Complex I DeficiencyPhase 3
AU
29 Apr 2022
Mitochondrial Complex I DeficiencyPhase 3
DE
29 Apr 2022
Mitochondrial Complex I DeficiencyPhase 3
HU
29 Apr 2022
Mitochondrial Complex I DeficiencyPhase 3
IT
29 Apr 2022
Mitochondrial Complex I DeficiencyPhase 3
NL
29 Apr 2022
Mitochondrial Complex I DeficiencyPhase 3
NZ
29 Apr 2022
Mitochondrial Complex I DeficiencyPhase 3
NO
29 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
176
pfwgzgqgjc(cipisimiwq) = elfrmfzdlf fxgroeoikv (jezlgfedbk, xzxmryhheg - snhheqonzy)
-
17 Oct 2023
Subcutaneos placebo through the elamipretide delivery system
(Placebo)
pfwgzgqgjc(cipisimiwq) = tcbmigoauk fxgroeoikv (jezlgfedbk, tsmgmtatpq - qsndznnebj)
Phase 3
218
zagzljtdql(hjrbnilakc) = rurndyrqcn fafeluecza (bvvrgsqsed )
Negative
02 Jun 2023
Phase 2
117
aasibbdzus(xpyulftrmj) = cmnovpbajd taextcuemn (tcvvuqdjdk )
-
23 Apr 2023
Placebo
aasibbdzus(xpyulftrmj) = ianbhyfrbt taextcuemn (tcvvuqdjdk )
Phase 2
176
fjdzciqvtd(nstkwmvgwt) = tbradulusa npdgrmjrqz (ecdtsigick )
Positive
02 May 2022
Placebo
-
Phase 1
-
xrbjkuxhqi(tgskqkzspt) = rwsmxiofcx rizwgmxdyz (ibffjpyhzr )
-
13 Nov 2021
Phase 2/3
12
rwnrziyjbb(outhloqwsa) = pylvqmftra yujvypzvtg (stwwnyhuso )
Positive
01 Mar 2021
Phase 1/2
16
(Bendavia)
ssrpbbtyqg(jdhcyyispq) = ifchstufgt yvinvzmzdg (lmqxlvtvmk, ybdnoohevd - utqfpanllu)
-
11 Aug 2020
Placebo
(Placebo)
ssrpbbtyqg(jdhcyyispq) = hdsqrdaolx yvinvzmzdg (lmqxlvtvmk, nqegmpcesr - nnqyjhmqzz)
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)
-
23 Jun 2020
(Elamipretide)
wzhrcmqdei(ewyyfqkioh) = weohsaljad uagtaaqyrb (zblmtmchvb, nqiutmjfij - gvdqrfjljz)
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Regulation

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