Mitochondria · Longevity
A mitochondria-targeting peptide with a narrow accelerated approval and a much broader set of unproven anti-ageing claims.
Evidence passport
A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.
Routes recorded
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.
None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.
How far human research has progressed: Approved for one rare disease; investigational or unestablished elsewhere
Studied / approved routes
The approved product (Forzinity) is a subcutaneous injection studied specifically in Barth syndrome. Route, dose and population are tied to that programme; nothing transfers to anti-ageing use.
Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.
Discovery
Preclinical
Phase I
Phase II
Phase III
Approved
Accelerated US approval (September 2025) for Barth syndrome, contingent on a confirmatory trial; programmes in broader indications produced mixed or unsuccessful results.
A small peptide that concentrates in mitochondria and binds cardiolipin, a lipid essential to the structure of the inner mitochondrial membrane and to efficient energy production.
This is a textbook case of why 'approved' needs a footnote. Elamipretide has real human data and a genuine accelerated approval in a rare mitochondrial disease. Trials in broader indications — including some cardiac and ophthalmic programmes — have produced mixed or unsuccessful results. General anti-ageing and performance use is unestablished.
Useful next reads based on this compound — not recommendations.
MOTS-c evidence profile
A mitochondrial-derived peptide with genuinely interesting biology and thin translational data.
Compare SS-31 / Elamipretide vs MOTS-c evidence
Same questions, same fields, side by side — including how much human evidence exists.
Claim review: “Elamipretide is an approved anti-ageing therapy.”
Our verdict on this exact wording, with the reasoning behind it.
Safety Centre
What approved, investigational and unapproved actually mean for documented human safety.
Animal and cell findings are Level 1–2 evidence.
This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.
No established human signal
Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.
Named regulators: FDA (US)
On 19 September 2025 the FDA granted accelerated approval to Forzinity (elamipretide) injection to improve muscle strength in patients with Barth syndrome weighing at least 30 kg — based on a surrogate endpoint, with a confirmatory trial still required. That approval says nothing about general anti-ageing, athletic or longevity use, where it remains unapproved and unestablished. On 24 August 2026 the FDA issued warning letters to Royal Peptides LLC, Peptide Partners LLC and TXP Innovations LLC (Tex Peptides) identifying vendor products labelled 'SS-31 (Elamipretide)' as unapproved new drugs; those products are not the approved Forzinity medicine, and FDA noted that injectable products sold this way are especially concerning because injection bypasses key body defences.
FDA granted accelerated approval to Forzinity (elamipretide) for Barth syndrome in patients weighing at least 30 kg, on a surrogate endpoint with a confirmatory trial required. Does not cover anti-ageing or performance use.
Randomised and open-label extension — Patients with a rare mitochondrial genetic disease
Supported accelerated approval in that narrow indication only.
Preliminary human outcome research, including small or observational studies. Descriptive exposure studies alone do not demonstrate therapeutic benefit.
Source transparency
A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.
Review provenance
Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.
Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.
Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.
These entries record changes to our assessment of the published evidence — not changes to the compound itself.
Claim verdict
Mitochondria
“Elamipretide is an approved anti-ageing therapy.”
This verdict applies to the exact claim above. It is not a verdict on the compound overall, a safety guarantee, or a recommendation to use it.
Registry verdict
Misleading — it holds a narrow accelerated approval for a rare genetic disease.