SS-31, elamipretide and Forzinity
FDA records September 19, 2025 as the initial US approval date for Forzinity, an elamipretide product. Its label describes elamipretide as a mitochondrial cardiolipin binder and limits the indication to improving muscle strength in patients with Barth syndrome who weigh at least 30 kg. FDA Forzinity approval snapshot, Forzinity prescribing information.
That is a product-specific indication with a named disease, purpose and weight threshold. It is not an approval for every mitochondrial-health claim or for the SS-31 (Elamipretide) vial in this catalogue. The vial is listed with 10mg / 50mg variants, which do not establish equivalence to Forzinity. Forzinity prescribing information.
Trial results and accelerated-approval endpoint
Forzinity received accelerated approval for its labeled indication based on knee-extensor muscle strength. Continued approval may depend on verification of clinical benefit. Forzinity prescribing information.
The label also states that the randomized trial was not superior to placebo on its primary six-minute-walk and fatigue endpoints. Those primary endpoints are different from knee-extensor strength. Forzinity prescribing information.
Forzinity side effects
The Forzinity label identifies injection-site reactions as its most common adverse reactions. This is information about the named labeled product, not an observed reaction rate for the supplier SS-31 vial. The label does not authenticate the catalogue product or establish Thai approval. Forzinity prescribing information, FDA Forzinity approval snapshot.
The separate SS-31 (Elamipretide) Pen is another catalogue presentation with 10mg / 50mg variants. The shared research name and amount options do not transfer Forzinity's restricted indication or demonstrate matching formulation and performance. Forzinity prescribing information.
SS-31 and Forzinity questions
Does the approval support a general mitochondrial benefit claim?
The US indication is specifically to improve muscle strength in patients with Barth syndrome weighing at least 30 kg. The broader phrase mitochondrial benefit would remove the disease, endpoint and population limits in that label. Forzinity prescribing information.
