SS-31

Half-life context

Unknown. No verified human value is generalized here to research-labeled SS-31 products.

Regulatory status

Checked 2026-10-09

FDA product approval

approved product. Forzinity (elamipretide) has accelerated FDA approval for Barth syndrome in patients weighing at least 30 kg. This does not approve other uses or research products.

Compounding

not established. Compounded products do not carry FDA product approval; legal eligibility is not established here.

Research status

product specific. Barth syndrome patients meeting the approved Forzinity criteria; accelerated approval uses a surrogate endpoint.

Sport status

unknown. Not individually verified; consult your sport authority.

Evidence B

Randomized human investigational evidence; applicability is limited to the studied population.

Grades describe the cited population and indication, not safety or suitability for an individual.

Population: Barth syndrome patients meeting the approved Forzinity criteria; accelerated approval uses a surrogate endpoint.

Indication: Approved labeled indication only.

Basis: Product-label clinical evidence.

Risks

• Injection-site reactions were the most common adverse reactions reported with the approved Forzinity product.
• The approved product label warns about hypersensitivity; approval does not establish the safety or quality of research-market preparations.

Contraindications

• Unknown or incomplete for research formulations; this is not a clearance for use.

Interactions

• Unknown or incomplete; do not infer compatibility with medications or other substances.

What to record

• Existing clinician-directed records, symptoms and dated health measurements.
• Record missing data; trends do not demonstrate causation.

A licensed clinician must interpret the evidence for your situation. This entry provides education, not treatment instructions.

Review: source-curated; clinician review pending

Sources

• Primary evidence or regulator source. Checked 2026-10-09