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FDA-approved drugLongevity & Cellular ResearchSS-31, MTP-131

Elamipretide (SS-31)

Also known as: SS-31, Bendavia

Elamipretide (SS-31) is a synthetic, cell-permeable tetrapeptide that concentrates in the inner mitochondrial membrane. It has a large preclinical literature and has been studied in multiple human clinical trials.

Evidence: moderate · Human trials plus extensive animal and cell work

At a glance

Class
Mitochondria-targeted tetrapeptide
Developer
Stealth BioTherapeutics
FDA status
FDA-approved prescription drug (brand: Forzinity), accelerated approval, September 2025. This page covers the research compound only.
Human data
Phase 3 randomized, placebo-controlled trial published (MMPOWER-3, 218 adults); other trials registered
Animal / lab data
Mouse, rat, dog and pig models; isolated mitochondria and cardiomyocytes

Where it’s been studied

12
  • 1HeartMicroembolization LV-dysfunction model, dogs (2016); aged mice (2020); tafazzin-knockdown mice (2022)
  • 2MitochondriaCardiolipin binding, supercomplex assembly; reviewed (2025)

Mechanism studied

Elamipretide localizes to the inner mitochondrial membrane and binds selectively to cardiolipin, a phospholipid that supports cristae structure and respiratory-chain assembly [1]. Binding lowers the membrane's surface charge without changing transmembrane potential, and studies report improved respiratory supercomplex organization and reduced proton leak through ANT1 [1][5]. Early work framed it as a free-radical scavenger; more recent evidence proposes it reduces ROS production upstream rather than scavenging radicals directly, which remains an area of active study [1][4].

What the research shows

StudyModelReported resultSource
MMPOWER-3 [2]Human
Adults, randomized, double-blind, placebo-controlled, 24 weeks
Phase 3, 218 participants. Primary endpoints: prespecified functional measures (see publication). Published.Peer-reviewed
Neurology 2023
Chronic administration in a canine LV-dysfunction model [3]Other animal
Intracoronary microembolization model, dogs (n=14), 3 months vs saline
Researchers measured LV function, myocardial energetics and NT-proBNP vs saline; see publication.Peer-reviewed
Circ Heart Fail 2016
Late-life exposure in old mice [4]Mouse
Old mice, 8 weeks of SS-31
Researchers measured diastolic function vs young mice; cardiomyocyte proton leak normalized and mitochondrial ROS reduced; cMyBP-C phosphorylation increased.Peer-reviewed
eLife 2020
Tafazzin-knockdown cardiac mitochondria [5]Mouse
Tafazzin-knockdown (TazKD) mouse model, isolated cardiac mitochondria
SS-31 improved mitochondrial respiratory capacity and supercomplex organization without changing the MLCL/cardiolipin ratio.Peer-reviewed
Sci Rep 2022
Mechanism review [1]Review
Review of cell, animal and human literature
Summarizes cardiolipin binding, supercomplex assembly, ANT1 interaction and ATP synthasome stabilization as the current mechanistic model.Peer-reviewed
Biomed Pharmacother 2025

Human trials are listed for research context only; outcomes are reported in the linked publications. Animal and lab results do not establish effects in humans.

Supply

PureLab does not supply this compound. This page summarizes published research only.

More in Longevity & Cellular Research

Sources

  1. Sabbah HN et al. (2025). doi:10.1016/j.biopha.2025.118056 Source
  2. Karaa A et al. (2023) Source
  3. Sabbah HN et al. (2016) Source
  4. Chiao YA et al. (2020). doi:10.7554/eLife.55513 Source
  5. Russo S et al. (2022) Source
  6. U.S. FDA (2025) Source
For research use only. Not for human or veterinary use. Not a drug, food or cosmetic, and not intended to diagnose, treat, cure or prevent any disease. This library summarizes published research for educational purposes. PureLab Performance Inc.