Forzinity received a narrow US accelerated approval in 2025 for muscle strength in Barth syndrome in patients meeting the labeled weight threshold.
The small study and approval conditions matter. This is not approval for general fatigue, anti-aging, athletic optimization or every research-grade SS-31 vial. FDA’s trial snapshot reports that the randomized primary endpoints were not superior to placebo; strength increases were observed during the extension.
Sources and proposed-mechanism explanation
Mitochondrial membrane biology explains research interest. “Mitochondrial support” must be translated into a defined patient outcome.