Evidence profile
SS-31 (50 mg Vial)
Elamipretide has been studied in mitochondrial disease and is the ingredient in a US-authorized medicine for a specific Barth syndrome indication.
01
Product identity
Research SS-31 vials and the manufactured medicine have different documentation requirements.
02
What has been studied
Regulatory approval summary / Authorized-product label
The US regulatory decision
- Population or model
- A specific Barth syndrome population; Adult and pediatric Barth syndrome patients meeting label criteria
- Study route or material
- Authorized US product; Manufactured injection solution
FDA granted accelerated approval to Forzinity for a defined Barth syndrome population. The original trial enrolled 12 participants. Elamipretide did not outperform placebo on the randomized phase’s primary walking-distance and fatigue endpoints. The approval relied on muscle-strength findings from the longer open-label period, with further confirmation required. These distinctions matter when interpreting the authorization.[1][2]
03
Evidence limits
US approval does not establish Canadian authorization of the linked product.
The approval does not validate general longevity, exercise or unrelated disease claims.
The reviewed sources do not establish patient instructions for this product. No dose, cycle, preparation method or administration schedule is provided here.
04
Formulation and handling evidence
Exact chemical identity, salt form and labeled peptide amount.
Canadian authorization and product-specific formulation documents, if a medicinal product is claimed.
A compatible diluent, prepared-solution stability and container/device compatibility must be supported for the exact formulation. The diluent manufacturer’s instructions do not supply a universal storage period for every dissolved substance.[4]
05
Approval context
Forzinity’s accelerated approval has a defined indication and evidence basis.[1][2]
06
Sources and review scope
- FDA review snapshot: ForzinityRegulatory approval summary · Fresh FDA trial snapshot: approval scope, study design, randomized endpoints and open-label evidence limitations · Checked 2026-09-09
- Forzinity US prescribing informationAuthorized-product label · FDA label · Checked 2026-09-08
- Health Canada: unauthorized injectable peptide productsRegulatory advisory · Fresh Health Canada advisory read, including product/DIN and RUO-label limits · Checked 2026-09-09
- Hospira/Pfizer: bacteriostatic water manufacturer informationManufacturer information; US presentation · Fresh manufacturer page, relevant compatibility/storage/supply passages · Checked 2026-09-09
- Amino Labs: SS-31 | 50mgSupplier listing; identity reference · Exact heading, SKU, form and supplier URL from the full catalogue capture; not stock-lot authentication · Checked 2026-09-09
This is a selected-source evidence summary. It is not a systematic review, formal certainty grade or qualified clinical sign-off. Study dates and source-check dates are distinct.