SS-31 (Elamipretide)
FDA APPROVED · RXMitochondrial-targeted peptide
Also known as: Elamipretide, Forzinity, MTP-131
FDA approved (accelerated approval, September 2025) as Forzinity to improve muscle strength in Barth syndrome, a rare mitochondrial disorder. Broad 'anti-aging' use is not approved.
Strong, human-grade evidence
- Regulatory standing. FDA-approved prescription medicine
- Human trials. Backed by controlled human studies
- Registered human trials. 1 registered study on ClinicalTrials.gov, most advanced Phase 2
- 2 cited sources. Includes primary / regulatory sources
A read on the weight of evidence and regulatory standing behind this compound. It is not a safety score, not a purity or quality rating, and not medical advice. It is not a claim that this compound treats, cures, or prevents any condition, and not an endorsement or a recommendation to buy or use it. A low score means the evidence is thin — not that a product is unsafe; a high score means the evidence is strong — not that anyone should take it. PLOBT is independent and takes no money from any vendor; no company can pay to change this score.
Proven: strong preclinical mitochondrial data, plus a Phase 3 result good enough for FDA accelerated approval in the rare disease Barth syndrome. NOT proven: the general anti-aging and performance claims it is marketed for outside that indication.
What it is
A peptide that concentrates in mitochondria and stabilises cardiolipin, improving mitochondrial function and reducing oxidative stress.
What the research says
Phase 3 and expanded-access data supported FDA accelerated approval in 2025.
Strong animal evidence that it restores mitochondrial quality and exercise tolerance.
Marketed for longevity, but this is not the approved or evidenced use.
Published literature
Live from Europe PMC. Peer-reviewed papers discussing SS-31 (Elamipretide) in their title or abstract, most-cited first. This is how much has been published — not how much is proven in humans. It counts landmark trials, animal studies and reviews alike.
Mitochondria Protection after Acute Ischemia Prevents Prolonged Upregulation of IL-1<i>β</i> and IL-18 and Arrests CKD.
Improving mitochondrial function with SS-31 reverses age-related redox stress and improves exercise tolerance in aged mice.
Late-life restoration of mitochondrial function reverses cardiac dysfunction in old mice.
The mitochondria-targeted peptide SS-31 binds lipid bilayers and modulates surface electrostatics as a key component of its mechanism of action.
Registered human trials
Live from ClinicalTrials.gov, the US NIH registry of human studies, refreshed daily. Counts studies where SS-31 (Elamipretide) is the intervention being tested.
FDA recalls & enforcement
No FDA recalls are on record for SS-31 (Elamipretide).
Source: openFDA drug enforcement.
What people log it for
Descriptive, based on what users track. Not an endorsement or a suggested use.
Risks & unknowns
- Approved only for a specific rare disease; broad use is off-label.
- Gray-market versions are unverified.
Doses reported in studies & protocols
Approved dosing is set by the label and prescriber. This is not a recommendation.
Purity reality
Pharmacy Forzinity is verified; gray-market SS-31 is not.
None yet. PLOBT does not publish invented purity numbers. Real third-party COA data, mapped to vendor and batch, is in development — and it is the one thing we refuse to fake.
Sources
- FDA approves Barth syndrome treatment, Johns Hopkins Hub, 2025
- Campbell et al., SS-31 & age-related redox stress, 2018 (PMC/NIH)
We cite peer-reviewed journals, PubMed/PMC, FDA and university sources, not vendor marketing.