A mitochondria-targeting peptide that received FDA accelerated approval in September 2025 for Barth syndrome, an ultra-rare genetic disease. Not authorized in Canada; Health Canada lists SS-31 among seized unauthorized injectables.
How strong is the human evidence?
- Cell & animal
- Small human studies
- Some randomized trials
- Large randomized trials
What is SS-31?
Elamipretide binds cardiolipin in the inner mitochondrial membrane. The FDA approved it as Forzinity for Barth syndrome in patients weighing at least 30 kg, based on improved knee-extensor muscle strength, and requires a confirmatory trial.
Is SS-31 legal in Canada?
Not authorized: no product found in the Drug Product Database, and SS-31 appears in Health Canada's list of seized unauthorized injectables.
What the research shows
- TAZPOWER open-label extension (Thompson et al. 2024): in 10 Barth syndrome patients (8 reached week 168), walking distance and fatigue scores improved.
What it doesn't show
- The approval is for a rare mitochondrial disease, not ageing, energy or performance in healthy people.
- Accelerated approval relies on an intermediate endpoint; clinical benefit still has to be confirmed.
Common questions
Is SS-31 legal in Canada?
No. It is not authorized, and Health Canada lists SS-31 among seized unauthorized injectables.
Is elamipretide FDA approved?
Yes, accelerated approval in September 2025, for Barth syndrome only.
Sources
- FDA (Sep 19, 2025): Accelerated approval of Forzinity (elamipretide) for Barth syndrome
- Health Canada advisory RA-81874 (Apr 9, 2026): Think twice before injecting peptides bought online
- Health Canada Drug Product Database (searched Nov 10, 2026)
- Thompson WR et al. Long-term elamipretide in Barth syndrome: TAZPOWER 168-week extension. Genet Med 2024
