Any new or unusual symptom after dosing. Because this compound has little or no human safety data, there is no established list of 'expected' effects to reassure you against — treat anything abnormal as a signal.
Stop at the first clearly abnormal reaction and reassess. Keep the vial and lot number in case you need to describe what you actually took.
Any severe or fast-worsening symptom — difficulty breathing, chest pain, fainting, severe pain — is a 911 call regardless of the compound.
Allergic reaction: hives, swelling of the lips, tongue or throat, wheezing or dizziness can escalate to anaphylaxis within minutes — call 911 immediately. Site infection: spreading redness, heat, swelling, pus or fever is not wait-and-see; an abscess or cellulitis can need drainage or IV antibiotics. Unverified product: grey-market vials are frequently mislabelled or contaminated, so a reaction may be to endotoxin or the wrong contents, not the named compound.
An aromatic-cationic tetrapeptide that concentrates several thousand-fold in the inner mitochondrial membrane, where it binds cardiolipin — the signature phospholipid of that membrane. By stabilising cardiolipin's interactions with cytochrome c and the respiratory supercomplexes, it improves electron transport efficiency and reduces reactive oxygen species leak. It is the most mechanistically specific molecule in this category, and the only one with a validated molecular target.
The success story of this group, and a useful reminder of what the others lack. Elamipretide completed a full development programme in primary mitochondrial myopathy, Barth syndrome and ophthalmic disease. The road was not smooth: an FDA advisory committee voted 10-6 that it was effective for Barth syndrome in October 2024, the FDA nonetheless issued a complete response letter in May 2025, and approval followed only after resubmission.
FDA-approved — under accelerated approval, granted 19 September 2025 as Forzinity, for Barth syndrome in adult and paediatric patients weighing at least 30 kg. Barth syndrome is an ultra-rare genetic mitochondrial disease; this is the first therapy ever approved for it. Accelerated approval means continued marketing is contingent on confirmatory trials verifying clinical benefit. The approval covers Barth syndrome only — it is not an approval for general mitochondrial support, ageing, or performance.
Real trial safety data exist, which distinguishes it sharply from the rest of this category. Injection-site reactions are the most common finding. Efficacy, not safety, was the limiting question throughout its development.
Forzinity (approved): 40 mg once daily SC for Barth syndrome, per the FDA label. Earlier trials in other conditions used various IV and SC regimens.
Reported from clinical trials or FDA labelling as a matter of record. It is not a recommendation, and for unapproved compounds no dose has been shown safe or effective in humans.
Above is what was administered in trials or on FDA labels, reported as fact. We do not convert it into a personal protocol, calculate a dose for your body weight, or tell you what to inject or how to reconstitute it — that decision belongs with a licensed physician. See our editorial policy.
Regulatory status changes. This page reflects our reading of public sources as of July 2026 and should be independently verified before it is relied upon.