PEPTIDE RESEARCH TOPIC

SS-31 / Elamipretide Research Peptide

Explore SS-31 and Elamipretide, mitochondrial research, Barth syndrome clinical evidence, Forzinity approval, and limits of broader research claims.

TOPIC OVERVIEW

About SS-31 / Elamipretide

Identity and names

Elamipretide is also known by research names SS-31, MTP-131, and Bendavia. Forzinity names a particular FDA-approved elamipretide medicine.

Compound type

It is a synthetic tetrapeptide studied in mitochondrial biology. Laboratory materials and the approved formulation are different product contexts.

Mechanism

Research investigates mitochondrial inner-membrane interactions and bioenergetic function. A mechanism does not establish effectiveness across all mitochondrial or aging conditions.

Research focus and evidence

Clinical development includes Barth syndrome and other disease-specific studies. Results must be interpreted by indication rather than generalized to wellness claims.

Regulatory status and limits

FDA granted Forzinity accelerated approval on September 19, 2025 to improve muscle strength in Barth syndrome patients weighing at least 30 kg. This limited approval does not authorize every SS-31 product or use.

Topics covered
  • mitochondrial research
  • Barth syndrome evidence
  • Forzinity approval
  • indication-specific limitations
Common names and related terms: SS-31, Elamipretide, MTP-131, Bendavia
RESEARCH SUMMARY

What Is SS-31 / Elamipretide?

LAST VERIFIEDOctober 7, 2026

FDA granted accelerated approval to Forzinity for a defined Barth syndrome population in September 2025. The agency describes continuing confirmatory research as part of the accelerated-approval pathway. FDA, Forzinity approval

The FDA prescribing information identifies the approved formulation, indication, and safety information. These boundaries should accompany discussion of elamipretide and must not be extended to unapproved research preparations or general anti-aging use. FDA, Forzinity prescribing information

RESEARCH TRACKER

SS-31 / Elamipretide Development & Clinical Research

Current programs, research areas, study status, enrollment, and expected completion dates organized from primary registry records.

LAST VERIFIEDOctober 7, 2026
Registered records20
Active studies3
Completed studies14
Phase 3 studies4
DeveloperRegistry sponsors include Stealth BioTherapeutics Inc., David Marcinek. Sponsor identity does not establish product approval.
AliasesSS-31, Elamipretide, MTP-131, Bendavia
Biological targetsResearch investigates mitochondrial inner-membrane interactions and bioenergetic function. A mechanism does not establish effectiveness across all mitochondrial or aging conditions.
Development stageRegistered intervention phases: Phase 1, Phase 1 / Phase 2, Phase 2, Phase 2 / Phase 3, Phase 3, Phase 4. See study-specific context.
Regulatory statusFDA granted Forzinity accelerated approval on September 19, 2025 to improve muscle strength in Barth syndrome patients weighing at least 30 kg. This limited approval does not authorize every SS-31 product or use.

What current projects are studying

Barth SyndromePrimary Mitochondrial DiseaseHeart FailureAge Related Macular Degeneration (ARMD)Friedreich AtaxiaAging, HealthyMitochondrial Myopathies
SELECTED CURRENT RESEARCH

Latest and important projects

Showing 3 of 3 active studies
ReNEWNCT06373731

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

Age Related Macular Degeneration (ARMD)

Phase
Phase 3
Status
Active Not Recruiting
Enrollment
313 Actual
Expected completion
Sep 2027
Record updated
Sep 17, 2026
Lead sponsor
Stealth BioTherapeutics Inc.
4TAZPowerNCT07531251

Clinical Trial in Patients With Barth Syndrome- 4TAZPower

Barth Syndrome

Phase
Phase 4
Status
Recruiting
Enrollment
48 Estimated
Expected completion
Nov 30, 2029
Record updated
Sep 17, 2026
Lead sponsor
Stealth BioTherapeutics Inc.
SHAPENCT07275424

Study of Healthy Aging and Physical Function With Elamipretide

Aging, Healthy

Phase
Phase 2
Status
Recruiting
Enrollment
30 Estimated
Expected completion
Apr 15, 2026
Record updated
Dec 10, 2025
Lead sponsor
David Marcinek
Primary sources: ClinicalTrials.gov (defined search)Checked October 7, 2026. Counts include interventional registry records with an explicit matching intervention name or alias; broad search results, biomarker-only observations, and unrelated compounds are excluded. Active includes recruiting, not yet recruiting, active not recruiting, and enrolling by invitation. PubMed is the linked title/abstract query count, not a number of clinical trials or a measure of evidence quality.

Registry status does not establish safety, efficacy, or regulatory approval.

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Essential SS-31 / Elamipretide guides

SS-31 / ELAMIPRETIDE KNOWLEDGE ARTICLESPage 1 of 7
04
KNOWLEDGE ARTICLE

SS-31 Peptide Benefits: What Research Shows

SS-31 peptide benefits include mitochondrial energy support and reduced oxidative stress in research. Learn what studies show about dosing and safety.

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05
KNOWLEDGE ARTICLE

MOTS-c SS-31 Stack: Research Guide & Protocol

Learn how the MOTS-c SS-31 stack works, why researchers study these mitochondrial peptides together, and key protocol timing and safety notes.

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09
KNOWLEDGE ARTICLE

SS-31 for Sale: Research Peptide Buyer's Guide

SS-31 for sale listings are research-only. Learn what elamipretide is, typical lab handling, purity checks, and how to vet peptide vendors in the USA.

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11
KNOWLEDGE ARTICLE

SS-31 Peptide: What It Is, Research, and Safety

SS-31 peptide, also called elamipretide, is a mitochondria-targeted research peptide. Learn what studies show, its FDA status, and safety concerns.

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16
KNOWLEDGE ARTICLE

SS-31 Peptide SubQ Dosage: What Research Shows

SS-31 peptide subQ dosage is a research-only topic. Learn how elamipretide is studied, typical lab protocols, and why no human dose is established.

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17
KNOWLEDGE ARTICLE

SS-31 Before MOTS-c: Stack Order and Timing

Thinking about running SS-31 before MOTS-c? Learn how these research peptides are typically sequenced, why timing matters, and what safety questions remain.

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19
KNOWLEDGE ARTICLE

SS-31 Peptide Benefits: What Research Shows

SS-31 peptide benefits center on mitochondrial support, and early research explores kidney, heart, and muscle effects. Here's what human trials show so far.

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20
KNOWLEDGE ARTICLE

SS-31 Side Effects: What Research Shows So Far

SS-31 side effects reported in trials include injection site reactions, headaches, and fatigue. Learn what the research shows and when to talk to a doctor.

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