SS-31 Benefits: Claims vs What Studies Show
Benefits people claim for SS-31, set against what published studies measured, and where no study exists.
- Strongest evidence
- Human RCT
- Human / animal studies
- 12 / 2
- in our evidence file (PubMed search, 11 Oct 2026)
- FDA status
- accelerated approval for Barth syndrome (Sep 2025)
Claimed benefits and what studies show
Each row is an area where people claim a benefit, with the strongest study we summarise behind it. Animal and cell results are labelled and are not human results. User reports are not counted as evidence here.
| Claim | Best evidence | Studies (human / animal) | What was measured | Page |
|---|---|---|---|---|
| Energy | Human RCT evidence, 4 of 4 | 8 / 2 | 6MWT in CPEO subgroup (post hoc); 6-minute walk and fatigue at week 24; Walk distance difference | Evidence for energy |
| Strength | Human RCT evidence, 4 of 4 | 3 / 1 | Open-label extension, 36 weeks; 6-minute walk at week 168; 6-minute walk vs natural history | Evidence for strength |
| Heart health | Human RCT evidence, 4 of 4 | 1 / 2 | Left ventricular volumes; Cardiac function after MI; Mitochondrial function | Evidence for heart health |
| Eyes and vision | Human RCT evidence, 4 of 4 | 1 / 0 | Primary endpoints (low-luminance BCVA, GA growth) | Evidence for eyes and vision |
| Longevity | Human RCT evidence, 4 of 4 | 1 / 0 | Muscle mitochondrial capacity | Evidence for longevity |
Strongest study per claim: Energy, Orphanet journal of rare diseases 2024, PMID 39574155; Strength, Genetics in medicine 2021, PMID 33077895; Heart health, Circulation. Heart failure 2017, PMID 29217757.
What the studies measured
| Outcome | Result | Study type | Source |
|---|---|---|---|
| Primary endpoints (low-luminance BCVA, GA growth) | Primary endpoints were not met; a secondary imaging measure (ellipsoid zone loss) progressed 43% less than placebo (nominal P = 0.0034). | Human RCTn = 176 | Ophthalmology science 2025, PMID 39605874 |
| 6MWT in CPEO subgroup (post hoc) | In a post hoc subgroup with CPEO, walk distance changed by 37.3 m on elamipretide versus -8.0 m on placebo (p = 0.0024). | Human RCT | Orphanet journal of rare diseases 2024, PMID 39574155 |
| 6-minute walk and fatigue at week 24 | The pivotal randomized trial did not meet its primary endpoints (6-minute walk and fatigue score). | Human RCTn = 218 | Neurology 2023, PMID 37268435 |
| Walk distance difference | Walk distance difference versus placebo was -3.2 m (p = 0.69). | Human RCTn = 218 | Neurology 2023, PMID 37268435 |
| Primary endpoints (6MWT, BTHS-SA) in part 1 | Neither primary endpoint was met in the randomized crossover part. | Human RCTn = 12 | Genetics in medicine 2021, PMID 33077895 |
| Open-label extension, 36 weeks | In the uncontrolled extension at 36 weeks, 6-minute walk improved by 95.9 m and symptom score fell by 2.1 points. | Human RCTn = 12 | Genetics in medicine 2021, PMID 33077895 |
| Muscle mitochondrial capacity | Mitochondrial capacity rose right after a single 2-hour infusion (P = 0.055 and P = 0.045); the abstract reports no difference one week later. | Human RCTn = 39 | PloS one 2021, PMID 34264994 |
| Fatigue resistance | No significant effect on muscle fatigue resistance. | Human RCTn = 39 | PloS one 2021, PMID 34264994 |
| 6-minute walk | Walk distance was 19.8 m longer on elamipretide (398.3 vs 378.5 m), not statistically significant (P = 0.0833). | Human RCTn = 30 | Journal of cachexia, sarcopenia and muscle 2020, PMID 32096613 |
| Fatigue symptoms | Patient-reported fatigue and muscle complaints were lower on elamipretide (P = 0.0006 and P = 0.0018). | Human RCTn = 30 | Journal of cachexia, sarcopenia and muscle 2020, PMID 32096613 |
| 6-minute walk after 5 days | Highest-dose participants walked 64.5 m farther versus 20.4 m for placebo at day 5 (p = 0.053). | Human RCTn = 36 | Neurology 2018, PMID 29500292 |
| Left ventricular volumes | Highest dose reduced LV end-diastolic volume by 18 mL and end-systolic volume by 14 mL versus placebo at end of infusion. | Human RCTn = 36 | Circulation. Heart failure 2017, PMID 29217757 |
| 6-minute walk at week 168 | Walk distance improved at every extension time point, by a cumulative 96.1 m at week 168. | Human uncontrolled trialn = 10 | Genetics in medicine 2024, PMID 38602181 |
| 6-minute walk vs natural history | Treated patients walked 79.7 m further at week 64 and 91.0 m further at week 76 than natural-history controls. | Human observationaln = 27 | Orphanet journal of rare diseases 2022, PMID 36056411 |
| Muscle strength vs natural history | Handheld-dynamometry strength differed by 40.8 N at week 64 and 56.7 N at week 76 in favor of elamipretide. | Human observationaln = 27 | Orphanet journal of rare diseases 2022, PMID 36056411 |
| Skeletal muscle fibre type | Elamipretide restored a near-normal skeletal muscle fibre-type composition in heart-failure dogs. | Animal · dog (not a human result)n = 14 | ESC heart failure 2019, PMID 30688415 |
| Cardiac function after MI | Ejection fraction was 55.3% with Bendavia versus 49.3% with water six weeks after infarction. | Animal · rat (not a human result)n = 54 | Journal of cardiovascular pharmacology 2014, PMID 25165999 |
| Mitochondrial function | Elamipretide improved mitochondrial function in explanted failing human heart tissue. | In vitro (not a human result) | JACC. Basic to translational science 2019, PMID 31061916 |
The muscle strength claim
Claim: it improves muscle strength. The one regulatory result is narrow: the label indicates it to improve muscle strength in Barth syndrome patients weighing at least 30 kg.[21]
In a matched comparison with untreated Barth syndrome controls, elamipretide patients had handheld-dynamometry strength differences of 40.8 Newtons at 64 weeks and 56.7 Newtons at 76 weeks.[10]
The energy and fatigue claim
Claim: it reduces fatigue. The phase 3 trial in primary mitochondrial myopathy did not meet its primary endpoints for the 6-minute walk or total fatigue score.[3]
An earlier crossover trial found less fatigue on a symptom score with elamipretide, while its primary walking endpoint was not statistically significant.[6]
The heart claim
Claim: it helps the heart. A single infusion in heart failure patients lowered left ventricular volumes at the highest dose, compared with placebo.[8]
In rats after a heart attack, treatment reduced scar circumference and improved ejection fraction. This is animal data.[12]
The eye claim
Claim: it protects vision in macular degeneration. The phase 2 trial did not reach statistical significance for its primary end points, though it slowed ellipsoid zone loss.[1]
The anti-aging claim
Claim: it reverses aging in muscle. The only human data are a single-dose study in older adults, where the effect on mitochondrial capacity was gone by day 7.[5]
A PubMed search dated 2026-10-02 for elamipretide combined with fibromyalgia, fatigue or chronic pain returned 19 records, and the evidence file tags none of them as a longevity outcome.
Calculated from search query elamipretide[tiab] AND (fibromyalgia[tiab] OR fatigue[tiab] OR "chronic pain"[tiab]), date 2026-10-02, count 19; source web/src/data/evidence/ss-31.json searches. Formula: count = records returned by the dated PubMed query
More on SS-31
Common questions
Is SS-31 proven to work?
The strongest study we summarise for SS-31 is human rct evidence, among 15 studies. A trial result is not an approval; see the legal status.
What is SS-31 used for?
SS-31 is the research name for elamipretide, which is FDA-labelled only to improve muscle strength in Barth syndrome.[21]
More on SS-31
Sources
- 1ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation.Ophthalmology science · 2025PMID 39605874Accessed 2 Oct 2026
- 2Genotype-specific effects of elamipretide in patients with primary mitochondrial myopathy: a post hoc analysis of the MMPOWER-3 trial.Orphanet journal of rare diseases · 2024PMID 39574155Accessed 2 Oct 2026
- 3Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial.Neurology · 2023PMID 37268435Accessed 2 Oct 2026
- 4A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism.Genetics in medicine : official journal of the American College of Medical Genetics · 2021PMID 33077895Accessed 2 Oct 2026
- 5In vivo mitochondrial ATP production is improved in older adult skeletal muscle after a single dose of elamipretide in a randomized trial.PloS one · 2021PMID 34264994Accessed 2 Oct 2026
- 6A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy.Journal of cachexia, sarcopenia and muscle · 2020PMID 32096613Accessed 2 Oct 2026
- 7Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy.Neurology · 2018PMID 29500292Accessed 2 Oct 2026
- 8Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide.Circulation. Heart failure · 2017PMID 29217757Accessed 2 Oct 2026
- 9Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER.Genetics in medicine : official journal of the American College of Medical Genetics · 2024PMID 38602181Accessed 2 Oct 2026
- 10Natural history comparison study to assess the efficacy of elamipretide in patients with Barth syndrome.Orphanet journal of rare diseases · 2022PMID 36056411Accessed 2 Oct 2026
- 11Effects of elamipretide on skeletal muscle in dogs with experimentally induced heart failure.ESC heart failure · 2019PMID 30688415Accessed 2 Oct 2026
- 12Bendavia, a mitochondria-targeting peptide, improves postinfarction cardiac function, prevents adverse left ventricular remodeling, and restores mitochondria-related gene expression in rats.Journal of cardiovascular pharmacology · 2014PMID 25165999Accessed 2 Oct 2026
- 13Elamipretide Improves Mitochondrial Function in the Failing Human Heart.JACC. Basic to translational science · 2019PMID 31061916Accessed 2 Oct 2026
- 14PubMed search: (elamipretide[tiab] OR Bendavia[tiab] OR "MTP-131"[tiab] OR Forzinity[tiab] OR (("SS-31"[tiab] OR SS31[tiab]) AND (peptide*[tiab] OR mitochondri*[tiab] OR cardiolipin[tiab] OR Szeto[tiab]))) (526 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 15PubMed search: (elamipretide[tiab] OR Bendavia[tiab] OR "MTP-131"[tiab] OR Forzinity[tiab] OR (("SS-31"[tiab] OR SS31[tiab]) AND (peptide*[tiab] OR mitochondri*[tiab] OR cardiolipin[tiab] OR Szeto[tiab]))) AND (randomized[tiab] OR trial[tiab] OR patients[tiab]) (133 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 16PubMed search: (elamipretide[tiab] OR Bendavia[tiab] OR "MTP-131"[tiab] OR Forzinity[tiab] OR (("SS-31"[tiab] OR SS31[tiab]) AND (peptide*[tiab] OR mitochondri*[tiab] OR cardiolipin[tiab] OR Szeto[tiab]))) AND (half-life[tiab] OR pharmacokinetic*[tiab]) (11 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 17PubMed search: elamipretide[tiab] AND (TAZPOWER[tiab] OR "Barth syndrome"[tiab]) AND (randomized[tiab] OR crossover[tiab]) (6 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 18PubMed search: elamipretide[tiab] AND (macular[tiab] OR "geographic atrophy"[tiab]) (9 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 19PubMed search: elamipretide[tiab] AND (fibromyalgia[tiab] OR fatigue[tiab] OR "chronic pain"[tiab]) (19 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
- 20PubMed search: (elamipretide[tiab] OR Bendavia[tiab] OR "MTP-131"[tiab] OR Forzinity[tiab] OR (("SS-31"[tiab] OR SS31[tiab]) AND (peptide*[tiab] OR mitochondri*[tiab] OR cardiolipin[tiab] OR Szeto[tiab]))) AND (adverse[tiab] OR "side effect*"[tiab] OR safety[tiab] OR tolerab*[tiab] OR toxicity[tiab] OR "case report"[pt]) (77 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 11 Oct 2026
- 21FORZINITY prescribing information (FDA label)FDA label, DailyMed · current labeldailymed.nlm.nih.govAccessed 2 Oct 2026
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