SS-31.

Yes. SS-31 is the original research code (also written SS31). Elamipretide is the generic drug name. FORZINITY is the FDA-approved brand name marketed by Stealth BioTherapeutics. Earlier development codes were MTP-131 and Bendavia.

Partially. On September 19, 2025, the FDA granted accelerated approval to elamipretide as FORZINITY for Barth syndrome in patients weighing at least 30 kg. Outside of that indication, SS-31 is not FDA-approved and is sold by research suppliers as a research-use compound. See the FDA label at accessdata.fda.gov .

The TAZPOWER Phase 2/3 trial in Barth syndrome used 40 mg subcutaneously once daily, both in the 12-week randomized crossover phase and in the open-label extension that ran up to 168 weeks. The Forzinity FDA label uses the same 40 mg/day dose for patients ≥30 kg, with a 20 mg/day adjustment for adults with severe renal impairment. This is reported as label and trial information, not a PDP dosing recommendation.

Forzinity is supplied at 80 mg/mL ready-to-use and does not require reconstitution. Lyophilized research-use SS-31 vials commonly come in 10 mg or 50 mg sizes. A 10 mg vial reconstituted with 1.0 mL bacteriostatic water yields 10 mg/mL; a 50 mg vial reconstituted with 2.5 mL yields 20 mg/mL. Always verify your specific vial's label.

There is no PDP-endorsed personal-use cycle for SS-31. The Forzinity label uses continuous daily dosing in patients with Barth syndrome. The TAZPOWER trial structure was 12 weeks per period in the randomized phase, with up to 168 additional weeks in the open-label extension.

In TAZPOWER and other elamipretide trials, injection-site reactions (redness, swelling, itching) were the most common adverse events. Headaches, mild nausea, and fatigue have also been reported. Forzinity's label flags hypersensitivity and benzyl alcohol content (do not use in neonates) as specific concerns.

Per the Forzinity label, anyone with serious hypersensitivity to elamipretide or excipients should avoid it, and it should not be used in neonates because it contains benzyl alcohol. Adults with severe renal impairment require a dose reduction (20 mg/day at eGFR <30 mL/min not on dialysis), and there is insufficient information for adults on dialysis. Healthy adults seeking anti-aging or performance use are not within any FDA-approved population.

Both are studied in mitochondrial-research contexts, but they work differently. SS-31 binds cardiolipin in the inner mitochondrial membrane to stabilize structure. MOTS-c is a mitochondrial-derived peptide that signals through pathways like AMPK. SS-31 has Phase 2/3 human data and one FDA approval (Barth syndrome). MOTS-c has preclinical and small human studies but no Phase 3 outcome trial. They are not interchangeable. See the MOTS-c protocol for more detail.

There is no published human randomized controlled trial demonstrating an anti-aging or athletic-performance benefit for SS-31 in healthy adults. The mechanism (cardiolipin stabilization) is biologically plausible, but mechanism plausibility is not proof of benefit. Most online claims in this space cite preclinical or anecdotal data, not human RCTs.

No. This page is an educational research reference. It reports trial-context dosing, FDA-label information, mechanism, and safety data from published sources. It is not a personal-use protocol, a prescription, or a substitute for evaluation by a qualified clinician.

Forzinity (the FDA-approved drug) is stored refrigerated at 36–46°F (2–8°C) and discarded 8 days after first opening, per its label. Lyophilized research-use SS-31 vials are typically stored long-term frozen at -4°F (-20°C); once reconstituted, they are stored refrigerated at 35.6–46.4°F (2–8°C), protected from light, and not refrozen.

The full FDA-approved label is at accessdata.fda.gov . The FDA approval letter is in the same docket. Both should be considered the source of truth for current Forzinity dosing, indications, and safety information.