SS-31
FDA ApprovedSS-31 is elamipretide, a cardiolipin-binding tetrapeptide. FDA granted accelerated approval to the specific Forzinity product to improve muscle strength in Barth syndrome patients weighing at least 30 kg; confirmatory clinical benefit remains to be verified. The larger MMPOWER-3 trial in primary mitochondrial myopathy missed both primary endpoints.
Elamipretide · Bendavia · MTP-131
Human evidence is indication-specific. US accelerated approval for Barth syndrome does not establish benefit in other conditions.
- Preclinical
- 13%
- Human research
- 15%
Based on 46 cited sources
46 visible records: 14 publications, 29 registrations and three FDA records. Seven direct human and six direct preclinical papers are counted separately from registrations and secondary material. A publication and registration may describe the same trial.
SS-31 is elamipretide, a tetrapeptide studied for binding cardiolipin in mitochondrial membranes. Biochemical and animal findings are a mechanistic basis, but clinical effects vary by condition. PMID:23813215
Product-specific FDA approval
On September 19, 2025, FDA granted accelerated approval to Forzinity (elamipretide) to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. Approval relied on knee-extensor muscle strength as an intermediate endpoint; a confirmatory trial is required to verify clinical benefit. This approval does not cover general mitochondrial support, longevity, heart failure, age-related macular degeneration or primary mitochondrial myopathy. The Forzinity label reports serious hypersensitivity reactions and frequent injection-site reactions. It describes the approved product, not the quality or safety of other SS-31 preparations. FDA approval announcement · FDA prescribing information
What the trials establish
In the 12-person randomized, placebo-controlled Barth syndrome crossover phase, neither prespecified primary endpoint (6-minute walk distance and symptom score) was met. Open-label extension and natural-history comparisons later showed favorable signals, but their design limits causal certainty. FDA’s approval was narrower than a general treatment claim. Barth randomized trial, PMID:33077895 · FDA trial snapshot
The 218-person MMPOWER-3 randomized trial in primary mitochondrial myopathy found no significant benefit on either primary endpoint at 24 weeks: six-minute walk distance or total fatigue. The study therefore does not support extending the Barth indication to that disease. PMID:37268435
Interactions with other mitochondrial supplements and peptides listed in older versions of this page have not been established as beneficial or safe combinations.
| NCT ID | Title | Peptide | Phase | Status | Completion |
|---|---|---|---|---|---|
| NCT02805790 | Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study Primary Mitochondrial Disease | SS-31 | Phase 2 | Completed | Mar 2017 |
| NCT03323749 | A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension Primary Mitochondrial Myopathy | SS-31 | Phase 3 | Terminated | Feb 2020 |
| NCT02367014 | Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy Mitochondrial Myopathy | SS-31 | Phase 1/2 | Completed | Apr 2016 |
| NCT03891875 | ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA Age-related Macular Degeneration | SS-31 | Phase 2 | Completed | Apr 2022 |
| NCT03098797 | A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome Barth Syndrome | SS-31 | Phase 2/3 | Completed | Oct 2021 |
| NCT02814097 | A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction Chronic Heart Failure | SS-31 | Phase 2 | Completed | Jun 2017 |
| NCT02388464 | A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure Congestive Heart Failure | SS-31 | Phase 1 | Completed | Jun 2015 |
| NCT02245620 | A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly Skeletal Muscle Mitochondrial Dysfunction in the Elderly | SS-31 | Phase 2 | Completed | Jul 2016 |
| NCT02693119 | A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy Leber's Hereditary Optic Neuropathy | SS-31 | Phase 2 | Completed | Dec 2019 |
| NCT02914665 | A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure Heart Failure | SS-31 | Phase 2 | Completed | Nov 2017 |
| NCT07531251 | Clinical Trial in Patients With Barth Syndrome- 4TAZPower Barth Syndrome | SS-31 | Phase 4 | Recruiting | Nov 2029 (estimated) |
| NCT07275424 | Study of Healthy Aging and Physical Function With Elamipretide Aging, Healthy | SS-31 | Phase 2 | Recruiting | Apr 2026 (estimated) |
| NCT06373731 | 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) | SS-31 | Phase 3 | Active not recruiting | Sep 2027 (estimated) |
| NCT05162768 | Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD) Mitochondrial Myopathies, Mitochondrial Pathology +6 more | SS-31 | Phase 3 | Completed | Dec 2024 |
| NCT05168774 | FRDA Investigator Initiated Study (IIS) With Elamipretide Friedreich Ataxia | SS-31 | Phase 1/2 | Completed | Jul 2024 |
| NCT02976038 | Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM) Primary Mitochondrial Disease | SS-31 | Phase 2 | Terminated | Apr 2020 |
| NCT02848313 | An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration Age-Related Macular Degeneration | SS-31 | Phase 1 | Completed | Apr 2018 |
| NCT02788747 | Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction Heart Failure | SS-31 | Phase 2 | Completed | Oct 2017 |
| NCT02653391 | A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED) Fuchs' Corneal Endothelial Dystrophy (FCED) | SS-31 | Phase 1/2 | Completed | Dec 2018 |
| NCT02388529 | A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure Heart Failure | SS-31 | Phase 1 | Withdrawn | Oct 2015 (estimated) |
| NCT02436447 | A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function Normal and Impaired Renal Function | SS-31 | Phase 1 | Completed | Oct 2015 |
| NCT02314299 | A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration Diabetic Macular Edema, Age-related Macular Degeneration | SS-31 | Phase 1/2 | Completed | Jun 2015 |
| NCT01786915 | Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days Healthy Volunteers | SS-31 | Phase 1 | Completed | Mar 2013 |
| NCT01755858 | Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery Renal Artery Obstruction, Hypertension, Renovascular +1 more | SS-31 | Phase 1/2 | Terminated | May 2016 |
| NCT01754818 | A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131) Healthy | SS-31 | Phase 1 | Completed | Feb 2013 |
| NCT01572909 | Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events Reperfusion Injury, STEMI | SS-31 | Phase 2 | Completed | Feb 2015 |
| NCT01518985 | The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking Healthy Volunteers | SS-31 | Phase 1 | Completed | Mar 2012 |
| NCT01513200 | Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia Healthy Volunteers | SS-31 | Phase 1 | Completed | Feb 2012 |
| NCT01115920 | Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults Healthy | SS-31 | Phase 1 | Completed | Sep 2010 |
Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study
A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension
Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy
ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA
A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly
A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy
A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure
Clinical Trial in Patients With Barth Syndrome- 4TAZPower
Study of Healthy Aging and Physical Function With Elamipretide
ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
FRDA Investigator Initiated Study (IIS) With Elamipretide
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction
A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED)
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bendavia™ (MTP-131) in Patients With Heart Failure
A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function
A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days
Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery
A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)
Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events
The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking
Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia
Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults
Key Studies Cited
Use the source links in the research discussion above to inspect the referenced records.
This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength labels summarize the cited material for this entry and should be read alongside its population, model, and study limitations.
For complete methodology details, see our Methodology page.
Important Disclaimer
This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.
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Compared With
4 comparisonsConditions Studied
4 entries- SS-31 for Primary Mitochondrial Myopathy SS-31 has been evaluated for primary mitochondrial myopathy in the Phase 3 MMPOWER-3 trial (NCT03323749), which was preceded by th…
- SS-31 for Barth Syndrome Barth syndrome is caused by TAZ gene mutations affecting cardiolipin remodeling, creating a direct mechanistic rationale for SS-31…
- SS-31 for Heart Failure PROGRESS-HF Phase 2 trial in HFrEF showed trends toward improved LVEF but did not meet primary endpoint (LVESV change). Preclinica…
- SS-31 for Age-Related Macular Degeneration The open-label Phase 1 ReCLAIM study (NCT02848313) reported exploratory low-luminance visual-acuity improvement. The randomized Ph…