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elamipretide

PeptideapprovedOrphan Drug FDA

Approved

Sep 19, 2025

Elamipretide (also known as SS-31, MTP-131 and Bendavia) is a small mitochondrially-targeted tetrapeptide (D-Arg-dimethylTyr-Lys-Phe-NH2) that appears to reduce the production of toxic reactive oxygen species and stabilize cardiolipin. — Wikipedia

Clinical trial activity

28 trials · 10 clinical orgs · 1 marketing orgs

Phase 1
14
Phase 2
17
Phase 3
4
Phase 4
0

Earliest trial started May 1, 2010 (NCT01115920)

Timeline

2010s

  1. Jan 1, 2010

    Stealth BioTherapeutics Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Stealth BioTherapeutics Inc. — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2017

    Stealth BioTherapeutics Inc. — Earliest Phase 3 Sponsor(trial)

  4. Mar 22, 2018

    Orphan Drug Designation

2020s

  1. Sep 19, 2025

    Earliest FDA Approval

  2. Sep 19, 2025

    Stealth BioTherapeutics Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetAntioxidant

    antioxidant

Approval history

  • approvedPriority reviewSep 19, 2025

Chemistry & pharmacology

Loading structure…

SMILES

Cc1cc(O)cc(C)c1C[C@H](NC(=O)[C@H](N)CCCNC(=N)N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(N)=O
Mol. weight
639.8 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • arg-dmt-lys-phe-nh2
  • arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide
  • bendavia
  • bendavia
  • bendavia
  • d-arg-dmt-lys-phe-nh2
  • elamipretide
  • elamipretide
  • elamipretide
  • elamipretide
  • mtp-131
  • mtp-131
  • mtp-131
  • ss-31 peptide
  • ss31 peptide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06373731Phase 3May 30, 2024Stealth BioTherapeutics Inc.
NCT05168774Phase 1/Phase 2 (Phase 2)Mar 3, 2022Stealth BioTherapeutics Inc., University of Pennsylvania
NCT05162768Phase 3Dec 31, 2021Stealth BioTherapeutics Inc.
NCT03891875Phase 2Mar 27, 2019Stealth BioTherapeutics Inc.
NCT03323749Phase 3Oct 27, 2017Stealth BioTherapeutics Inc.
NCT03098797Phase 2/Phase 3 (Phase 3)May 1, 2017Stealth BioTherapeutics Inc.
NCT02976038Phase 2Dec 1, 2016Stealth BioTherapeutics Inc.
NCT02848313Phase 1Oct 1, 2016Duke University, Stealth BioTherapeutics Inc.
NCT02914665Phase 2Sep 1, 2016Stealth BioTherapeutics Inc.
NCT02805790Phase 2Jul 1, 2016Stealth BioTherapeutics Inc.
NCT02814097Phase 2Jun 1, 2016Humboldt University, SCIRENT Clinical Research and Science d.o.o., Stealth BioTherapeutics Inc.
NCT02788747Phase 2Jun 1, 2016Stealth BioTherapeutics Inc.
NCT02693119Phase 2Mar 1, 2016Stealth BioTherapeutics Inc., University of California, Los Angeles
NCT02653391Phase 1/Phase 2 (Phase 2)Dec 1, 2015Stealth BioTherapeutics Inc.
NCT02388529Phase 1May 1, 2015Stealth BioTherapeutics Inc.
NCT02436447Phase 1May 1, 2015Stealth BioTherapeutics Inc.
NCT02245620Phase 2Feb 1, 2015Stealth BioTherapeutics Inc.
NCT02367014Phase 1/Phase 2 (Phase 2)Feb 1, 2015Stealth BioTherapeutics Inc.
NCT02314299Phase 1/Phase 2 (Phase 2)Nov 1, 2014Stealth BioTherapeutics Inc.
NCT02388464Phase 1Jul 1, 2014Stealth BioTherapeutics Inc.
Showing 20 of 28 trials
Page 1 / 2

Organizations

Research & Development (10)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Stealth BioTherapeutics Inc.For profit282742010
Clinical Pharmacology of MiamiFor profit5012010
Duke UniversityAcademic/Hospital1012016
Harvard UniversityAcademic/Hospital1012012
Humboldt UniversityAcademic/Hospital1012016
ICONFor profit1012012
Mayo ClinicAcademic/Hospital1012012
SCIRENT Clinical Research and Science d.o.o.For profit1012016
University of California, Los AngelesAcademic/Hospital1012016
University of PennsylvaniaAcademic/Hospital1112022
10 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Stealth BioTherapeutics Inc.For profitMKTGSep 19, 2025