SS-31 (elamipretide): doses reported in published research

Sources checked 2026-10-07 · 7 cited studies (4 human, 3 animal, 0 cell culture)

SS-31 (elamipretide, D-Arg-Dmt-Lys-Phe-NH2) is a mitochondria-targeted tetrapeptide. Elamipretide received FDA accelerated approval in September 2025 as the prescription drug FORZINITY (elamipretide) for Barth syndrome; research-grade SS-31 sold for laboratory use is not that product.

Human data: phase 2/3 trials and the FDA label for the approved prescription product. These describe use under medical supervision in specific rare diseases.

Studies in people (4)

Human FDA label, FORZINITY (elamipretide): patients with Barth syndrome weighing 30 kg or more

Dose as reported: 40 mg (label also lists 20 mg for eGFR under 30 mL/min, not on dialysis)
Route: Subcutaneous
Frequency / duration: Once daily

Source wording: The recommended dosage of FORZINITY in patients weighing at least 30 kg is 40 mg subcutaneously once daily. Less than 30 mL/minute and NOT on dialysis 20 mg subcutaneously once daily

FDA-approved prescribing information, FORZINITY, DailyMed label version 10 (effective 2025-12-10). DailyMed ↗

Human Trial described in the FDA label: 12 people aged 12 or over, over 30 kg, with Barth syndrome; randomized, double-blind, placebo-controlled crossover

Dose as reported: 40 mg
Route: Subcutaneous
Frequency / duration: Once daily for 12 weeks; 192-week open-label extension

Source wording: once daily FORZINITY 40 mg injected subcutaneously for 12 weeks in 12 subjects ≥12-years-old and >30 kg with genetically confirmed Barth syndrome its 192-week, open-label, single-arm extension period

FDA-approved prescribing information, FORZINITY, DailyMed label version 10 (effective 2025-12-10). DailyMed ↗

Human 218 adults with primary mitochondrial myopathy, phase 3 randomized double-blind placebo-controlled trial (MMPOWER-3)

Dose as reported: 40 mg/day
Route: Subcutaneous
Frequency / duration: Daily for 24 weeks

Source wording: eligible participants were randomized 1:1 to receive either 24 weeks of elamipretide at a dose of 40 mg/d or placebo subcutaneously. Participants (N = 218) were randomized

Karaa A, Bertini E, Carelli V et al.. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology 2023. PubMed PMID 37268435 ↗

Human 12 people with Leber hereditary optic neuropathy, phase 2 vehicle-controlled trial

Dose as reported: 1% ophthalmic solution
Route: Eye drops
Frequency / duration: 52 weeks double-masked, then open-label extension up to 108 more weeks (frequency not stated in the abstract)

Source wording: administration of elamipretide 1% topical ophthalmic solution to patients with LHON over a 52-week double-masked treatment period, followed by an open-label extension (OLE) for up to 108 additional weeks of treatment. Twelve patients with LHON were included in this study.

Karanjia R, Sadun AA. Elamipretide Topical Ophthalmic Solution for the Treatment of Subjects with Leber Hereditary Optic Neuropathy: A Randomized Trial. Ophthalmology 2024. PubMed PMID 37923251 ↗

Animal studies (3)

Animal doses are listed exactly as the studies report them. They are not converted to human amounts here; doses do not translate between species by body weight.

Animal Mice on regular or high-fat/high-sugar diet

Dose as reported: 3 mg/kg
Route: Subcutaneous
Frequency / duration: 5 days per week for 10 months

Source wording: treated with 3 mg/kg of Elam or saline subcutaneously 5 days per week for 10 months

Nickel K, Zhu L, Mangalindan R et al.. Long-term treatment with Elamipretide enhances healthy aging phenotypes in mice. Aging Pathobiol Ther 2022. PubMed PMID 36250163 ↗

Animal Mice (traumatic brain injury model)

Dose as reported: 5 mg/kg
Route: Intraperitoneal
Frequency / duration: Single dose 30 min after injury

Source wording: Peptide SS-31 (5 mg/kg) or vehicle was intraperitoneally administrated 30 min after TBI

Zhu Y, Wang H, Fang J et al.. SS-31 Provides Neuroprotection by Reversing Mitochondrial Dysfunction after Traumatic Brain Injury. Oxid Med Cell Longev 2018. PubMed PMID 30224944 ↗

Animal Animals (endotoxemia model; species not named in the abstract)

Dose as reported: 5 mg/kg
Route: Intraperitoneal
Frequency / duration: Immediately and 5 h after the procedure

Source wording: Immediately and at 5 h after the operation, SS-31 (5 mg/kg) or vehicle was administered intraperitoneally.

Li G, Wu J, Li R et al.. Protective Effects of Antioxidant Peptide SS-31 Against Multiple Organ Dysfunctions During Endotoxemia. Inflammation 2016. PubMed PMID 26231114 ↗

Half-life

No half-life value was found in the sources reviewed for this page.

The FDA label does not state a plasma half-life; it reports that about 100% of the dose is recovered in urine (as elamipretide or metabolites) by 48 hours in people with normal kidney function.

About this page

Every figure above is copied from the cited source; the source wording is shown with each entry. Where a source does not state something, the page says so.
Only abstracts, open-access full texts, registry records and FDA labels were used, so details found only in a paywalled full text may be missing.
This page does not convert doses between species or into other measures, and gives no preparation or handling information.