Elamipretide (SS-31) dosage in published studies and labels

These are the doses used for Elamipretide (SS-31) in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources: September 5, 2026

Studied regimens and sources

Elamipretide, also sold as SS-31, has an FDA-approved human dosage: 40 mg subcutaneously once daily, approved as Forzinity to improve muscle strength in adult and paediatric patients with Barth syndrome weighing at least 30 kg. The approval is narrow, and the wider programme in mitochondrial myopathy, dry age-related macular degeneration and cardiac reperfusion injury did not lead to approval in those conditions.

FDA Approved

Dosage evidence summary for Elamipretide (SS-31)
Human dosing established	Yes
Studied dose range	40 mg once daily (20 mg in severe renal impairment)
Route	Subcutaneous
Frequency	Once daily, at the same time each day
Duration studied	Continuous
Titration	None. The approved dose is fixed; the only adjustment is a reduction for severe renal impairment.
Evidence level	FDA Approved
Last reviewed	2026-09-05

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Elamipretide (SS-31), one row per studied regimen
Study / context	Population	Dose	Route	Frequency	Duration	Outcome studied	Source
FDA label — Forzinity, Barth syndromeFDA-approved label · FDA prescribing information	Adults and paediatric patients with Barth syndrome weighing at least 30 kg	40 mg (20 mg if eGFR below 30 mL/min and not on dialysis)	Subcutaneous	Once daily	Continuous	Muscle strength	FORZINITY (elamipretide hydrochloride) injection — FDA prescribing information, DailyMed
NCT05162768 — phase 3, Barth syndromeClinical trial · Phase 3 trial, completed	Subjects with Barth syndrome (n=102)	Per trial protocol	Subcutaneous	Once daily	Per trial protocol	Efficacy and safety in Barth syndrome	NCT05162768 — Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Barth Syndrome
ReCLAIM-2 — phase 2, dry age-related macular degenerationClinical trial · Phase 2 trial with posted results	Patients with dry AMD and geographic atrophy (n=176)	Per trial protocol	Subcutaneous	Once daily	48 weeks	Safety, efficacy and pharmacokinetics	NCT03891875 — ReCLAIM-2 Study to Evaluate Safety, Efficacy and Pharmacokinetics of Elamipretide
EMBRACE STEMI — phase 2, cardiac reperfusion injuryClinical trial · Phase 2 trial with posted results	Patients with ST-elevation myocardial infarction (n=300)	Per trial protocol (MTP-131 / Bendavia)	Intravenous	—	—	Reduction of reperfusion injury	NCT01572909 — Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury

Where sources disagree

The approved 40 mg daily dose is specific to Barth syndrome, a rare genetic cardiolipin disorder. Doses quoted elsewhere for general mitochondrial, longevity or performance purposes have no approved indication and no positive phase 3 trial behind them.
SS-31, elamipretide, MTP-131 and Bendavia are the same molecule under different development names. Trials are indexed under all four, which makes the evidence base look larger or smaller than it is depending on the name searched.
Research-grade SS-31 is typically sold in 10–50 mg vials with protocols in the low milligram range. The approved daily dose is 40 mg, substantially higher than most of those protocols, and was established under clinical monitoring in a rare-disease population.
This library lists elamipretide and SS-31 as separate profiles for the same compound. The evidence below is identical; SS-31, MTP-131 and Bendavia are earlier development names for elamipretide.