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This entry or formulation may be investigational and may not correspond to an FDA-approved product; safety and efficacy may not have been established. Kairo lists it for identification and record-keeping only.
Overview
Product & regulatory status
FDA granted Forzinity accelerated approval in 2025 for Barth syndrome in patients weighing at least 30 kg. Research-supplied SS-31 is not automatically that approved product.
Mitochondrial cardiolipin
Elamipretide binds cardiolipin, a component of the inner mitochondrial membrane. The approved product’s mechanism and evidence relate to a specific rare disease; they do not validate every claim about mitochondrial optimization. [1]
What the evidence shows
Specific indication
The approved product is intended to improve muscle strength in Barth syndrome. Accelerated approval requires further confirmation of clinical benefit. [2]
What supported the approval
The pivotal program included 12 patients with Barth syndrome in a randomized crossover trial followed by an open-label extension. The initial randomized portion did not show a significant strength difference; later open-label strength observations supported accelerated approval. Confirmatory evidence is required. This does not establish anti-aging benefits in healthy adults. [3]
What remains unknown
This indication does not establish an anti-aging or energy benefit in otherwise healthy people.
Safety
Product-specific precautions
The Forzinity label describes hypersensitivity and injection-site reactions. Its safety information applies to the labeled product and population. [1]
Approved product versus research powder
FORZINITY is a defined prescription formulation. Its labeling does not certify research powder sold under the SS-31 name or provide interchangeable preparation instructions for it. [1]
Understanding product quality
Compounded drugs are not FDA-approved finished products. Poor preparation can cause contamination or incorrect strength. A catalog entry or a research paper is not a quality assessment of your product. [4]
When to seek urgent help
Severe allergic symptoms such as trouble breathing, throat or tongue swelling, or fainting need immediate help. Call 911 or your local emergency number. This is general emergency information, not a complete list of risks for this compound. [5]
A starting point for discussion
This is not a complete list of adverse effects or interactions. Your health history, other medicines, and the exact formulation matter. Missing safety data is not evidence of safety.
Common questions
What should I ask when comparing products?
This indication does not establish an anti-aging or energy benefit in otherwise healthy people.
Questions for your clinician
Does the evidence match my condition and this exact product? What risks or interactions matter for me? How would we assess whether it is helping?
Sources
- FORZINITY (elamipretide) prescribing information2025 · US product label
- FDA Grants Accelerated Approval to First Treatment for Barth Syndrome2025 · FDA approval announcement · specific product and indication
- Drug Trials Snapshots: ForzinityFDA · pivotal trial and limitations · 2025 approval
- Compounding and the FDA: Questions and AnswersFDA · product quality and regulation
- AnaphylaxisMedlinePlus · recognizing an emergency
Educational information, not a recommendation to use a compound. Kairo does not give dosing advice. Review decisions with a licensed healthcare professional.