Is SS-31 FDA approved?

Elamipretide (SS-31) received FDA accelerated approval in September 2025 as Forzinity, only for Barth syndrome. Other uses are unapproved.

Is elamipretide the same as SS-31?

Yes — elamipretide is the drug/peptide name; SS-31 is the common research nickname.

Is elamipretide approved?

It has accelerated FDA approval for Barth syndrome. That is not approval for general anti-ageing or gym use.

Elamipretide (SS-31): What It Is and What Users Report

Elamipretide (SS-31): Barth syndrome approval context, mitochondrial research, and anonymous user reports. Not general anti-ageing advice.

Anonymous user report. Not medical advice. Peptides discussed are not FDA-approved for the uses described. Editorial process →

FDA status: Forzinity for Barth syndrome

On September 19, 2025, the FDA granted accelerated approval to Forzinity (elamipretide, also called SS-31) as the first treatment for Barth syndrome, a rare inherited mitochondrial disease, in patients weighing at least 30 kg. The approval rests on improved knee-extensor muscle strength, an intermediate endpoint, and a confirmatory placebo-controlled trial is required. It is not approved for anti-ageing, energy, fitness or other uses promoted online. Peptide Confessions does not publish dosing, timing, injection or sourcing guidance.

Short answer

Elamipretide is the drug name for the mitochondria-targeted peptide often called SS-31. It received FDA accelerated approval for Barth syndrome (a rare disease) — not as a general energy or anti-ageing drug for healthy adults. Research-chemical "SS-31" sold online is not the approved specialty product. Peptide Confessions does not publish dosing, timing, injection or sourcing guidance.

On this site

Anonymous SS-31 stories: SS-31 hub. Related: peptides for energy, MOTS-c.

More confessions from the archive

Community Q&A

Is SS-31 FDA approved?: Elamipretide (SS-31) received FDA accelerated approval in September 2025 as Forzinity, only for Barth syndrome. Other uses are unapproved.
Is elamipretide the same as SS-31?: Yes — elamipretide is the drug/peptide name; SS-31 is the common research nickname.
Is elamipretide approved?: It has accelerated FDA approval for Barth syndrome. That is not approval for general anti-ageing or gym use.
Does this page give dosing advice?: Peptide Confessions does not publish dosing, timing, injection or sourcing guidance.

Sources

Forzinity (elamipretide) prescribing information — DailyMed (NLM)

Anonymous first-hand reports plus sourced context — educational only, not medical advice. Editorial policy & corrections.