Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Investigational
Investigational. No FDA-approved elamipretide product is recorded for this entry. It has been studied in clinical trials.
ClinicalTrials.gov: elamipretideBy signing up you agree to get PeptideX update emails. Unsubscribe anytime. Educational only, not medical advice.
Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 340 PubMed citations indexed.
Mitochondria-targeted tetrapeptide binding cardiolipin in the inner mitochondrial membrane; reduces ROS production and prevents permeability transition pore opening.
What the literature studies
Mitochondrial Protection
Evidence tier
Human RCT
Compounding record
Status not verified
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source not verified; no checked date is assigned.
Phase II trials completed for HFpEF and Barth syndrome
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.
Elamipretide (SS-31), branded Forzinity, received FDA accelerated approval Sep 19 2025 to improve muscle strength in Barth syndrome patients weighing at least 30 kg; confirmatory trials are required, and gray-market "SS-31" research vials are not Forzinity.
A mitochondria-targeting tetrapeptide (Szeto-Schiller peptide SS-31; elamipretide) that binds cardiolipin on the inner mitochondrial membrane; developed by Stealth BioTherapeutics as Forzinity injection [R1][R2].
FDA granted accelerated approval Sep 19 2025 to Forzinity (elamipretide) injection to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg (NDA 215244) [R1][R2]. Approval is based on an intermediate endpoint (knee-extensor strength) reasonably likely to predict benefit; FDA requires a post-approval randomized confirmatory trial, and may withdraw accelerated approval if benefit is not verified [R1][R2]. Research-chemical "SS-31" sold online is not the approved Forzinity product.
Extensive mitochondrial/cardiolipin preclinical literature exists; US approval is indication-specific to Barth syndrome under accelerated approval - not a general longevity claim.
FDA notes mild-to-moderate injection-site reactions as common and that serious reactions have been reported [R1]. Benefit outside Barth syndrome is not an FDA-approved claim. Gray-market peptides: unverified identity/purity.
Confirmatory RCT (4TAZPOWER / postmarketing requirement) with primary completion targeted later this decade [R4]. Watch whether verified clinical benefit maintains accelerated approval.
Last checked 2026-10-27
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