Also known as:SS-31· development/common nameForzinity· brand name
Mitochondrial diseaseBarth syndrome
Elamipretide
Evidence levelLate-stage human
Human evidenceSubstantial
Regulatory statusFDA accelerated approval
What you need to know in 20 seconds
What is it?
Mitochondria-targeted tetrapeptide
Research focus
Mitochondrial disease; Barth syndrome; broader mitochondrial research
Human evidence
Elamipretide has multiple human trials. In primary mitochondrial myopathy, small early studies showed signals but the 218-person Phase III MMPOWER-3 trial missed both co-primary endpoints. Barth syndrome follows a separate rare-disease evidence and regulatory pathway and should not be generalized to wellness use.
Regulatory status
Forzinity (elamipretide) received FDA accelerated approval for Barth syndrome patients ≥30 kg; this does not make generic SS-31 vials approved.
Main limitations
General anti-ageing, energy or performance benefits are not approved/established by the Barth-syndrome authorization.
Safety
Safety is product/indication-specific; accelerated approval means confirmatory evidence is still required.
i
Elamipretide has multiple human trials. In primary mitochondrial myopathy, small early studies showed signals but the 218-person Phase III MMPOWER-3 trial missed both co-primary endpoints. Barth syndrome follows a separate rare-disease evidence and regulatory pathway and should not be generalized to wellness use.
What the evidence actually supports
✓For PMM, the large negative Phase III trial is more informative than earlier exploratory studies.
✓Do not generalize a narrow Barth-syndrome regulatory decision to generic SS-31 wellness or mitochondrial enhancement claims.
What is not established / key limitations
×MMPOWER-3 missed both 6MWT and fatigue co-primary endpoints.
×Blinded crossover primary endpoints were negative.
Selected study & evidence records
MMPOWER acute dose study in primary mitochondrial myopathy
2018 · Randomized placebo-controlled dose-ranging study · n=36
Highest-dose group improved 64.5 m versus 20.4 m with placebo; nominal P=.053, with dose-response signal and adjusted analyses favoring high dose.
2021 · Randomized double-blind placebo-controlled crossover study · n=12
Blinded primary endpoints were not significantly different; longer open-label extension produced signals used in the broader rare-disease evidence package.
Safety is product/indication-specific; accelerated approval means confirmatory evidence is still required.
Injection-site reactions are common in trials. Evidence and risk vary by indication and formulation; approval for a narrow rare-disease context does not establish generic SS-31 use as safe or effective.
Technical details
Mechanism / biologyBinds mitochondrial cardiolipin and is intended to improve mitochondrial bioenergetic function.
Route / formulation boundaryGeneric SS31 research products are not equivalent to Forzinity and may differ in quality/formulation.
Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.
Dosing evidence statusVerified dosing evidence added. US licensed dosing. See dosing_evidence records for route, regimen, population, duration and source.
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.
