HomePeptide dosagesSS-31 (elamipretide)
SS-31 (elamipretide) dosage: chart, reported range and vial math
The range reported for SS-31 is 1 to 10 mg, daily or twice a week. The approved product, Forzinity, is labelled at 40 mg under the skin once a day for Barth syndrome, a rare disease. Trials in other conditions did not meet their main goals. It is not authorized in Canada.
Legal status
US Approved for one use
Canada Not authorized
Checked 10 Oct 2026What is SS-31 (elamipretide)?SS-31 (elamipretide) dosage chart
Reported range, not a label dosePick your vial size. Each row shows the dose in milligrams or micrograms, the volume to draw and the mark on a U-100 syringe.
| Dose | Volume | Syringe units |
|---|---|---|
| 1 mg | 0.10 mL | 10 units |
| 5 mg | 0.50 mL | 50 units |
| 10 mg | 1.00 mL | 100 units |
Source Reported range, not a label dose. The approved product, Forzinity, is labelled at 40 mg once daily for Barth syndrome. Vial math is arithmetic.
Which syringe fits each dose
For the 20 mg vial at 10 mg/mL.
| Dose | Volume | Units | 0.3 mL syringe | 0.5 mL syringe | 1 mL syringe |
|---|---|---|---|---|---|
| 1 mg | 0.10 mL | 10 units | Yes | Yes | Yes |
| 5 mg | 0.50 mL | 50 units | No | Yes | Yes |
| 10 mg | 1.00 mL | 100 units | No | No | Yes |
How long a vial lasts
Whole doses in one vial. The row for the size picked above is marked.
| Vial | 1 mg | 5 mg | 10 mg |
|---|---|---|---|
| 20 mg vial | 20 doses | 4 doses | 2 doses |
How to mix a SS-31 (elamipretide) vial
These steps are for the 20 mg vial picked in the chart. Change the size there and the amounts here change with it.
- Wash your hands. Wipe the stopper of the peptide vial and the water vial with an alcohol swab.
- Draw 2 mL of bacteriostatic water into a syringe.
- Push the needle through the stopper of the peptide vial and let the water run slowly down the glass, not straight onto the powder.
- Swirl the vial gently until the powder is gone. Do not shake it.
- Write the date and 10 mg/mL on the vial, then put it in the fridge.
| Vial | Bacteriostatic water | Concentration |
|---|---|---|
| 20 mg vial | 2 mL | 10 mg/mL |
What SS-31 (elamipretide) is
SS-31, generic name elamipretide, is a four-amino-acid peptide that binds cardiolipin in the inner mitochondrial membrane. It is approved in the US as Forzinity, a once-daily injection under the skin for Barth syndrome. [12]
Other names: elamipretide, Forzinity, MTP-131, Bendavia, D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH2.
How it has been given to people: subcutaneous injection once daily (approved product); intravenous infusion in some earlier trials.
What to know before reading a dose
- Approved in the US for one rare disease, Barth syndrome, and under accelerated approval: the label says continued approval may depend on a confirmatory trial [1].
- The approval rests on muscle strength measured in an open-label extension of 8 to 10 patients. The 12-patient randomized trial missed both of its primary endpoints [1], [3].
- Randomized trials in other conditions did not meet their primary endpoints: primary mitochondrial myopathy [7], heart failure [8], heart attack [9] and dry age-related macular degeneration [10].
- Not authorized in Canada. Health Canada lists SS-31 among unauthorized injectable peptide drugs it has seized [14].
- The approved product is a ready-to-use 80 mg/mL solution for injection under the skin. The label says it is not approved for intravenous use and contains benzyl alcohol.
Doses on record for SS-31 (elamipretide)
Every dose below was given in a human study or printed on an approved label, and each links to its source. Doses set by body weight are left that way.
| From | Where it was used | Dose | How often | For how long | Source |
|---|---|---|---|---|---|
| Label | Forzinity, US label; subcutaneous injection into the abdomen or outer thigh | 40 mg | once daily | ongoing | [1] |
| Label | Forzinity, US label; subcutaneous injection; reduced dose for severe renal impairment | 20 mg | once daily | ongoing | [1] |
| Human study | Phase 2/3 TAZPOWER, randomized double-blind crossover part; subcutaneous injection | 40 mg | once daily | 12 weeks on drug, 12 weeks on placebo, 4-week washout between | [1] |
| Human study | TAZPOWER open-label extension; subcutaneous injection | 40 mg | once daily | up to 168 weeks | [4] |
| Human study | Phase 1/2 MMPOWER dose-escalation trial; intravenous infusion over 2 hours | 0.01, 0.1 or 0.25 mg/kg/hour for 2 hours | not stated in the abstract | 5 days of treatment | [5] |
| Human study | MMPOWER-2 randomized crossover trial; subcutaneous injection | 40 mg | once daily | 4 weeks | [6] |
| Human study | Phase 3 MMPOWER-3; subcutaneous injection | 40 mg | once daily | 24 weeks | [7] |
| Human study | Phase 2 PROGRESS-HF, heart failure with reduced ejection fraction; subcutaneous injection | 4 mg | once daily | 28 days | [8] |
| Human study | Phase 2 PROGRESS-HF, heart failure with reduced ejection fraction; subcutaneous injection | 40 mg | once daily | 28 days | [8] |
| Human study | Phase 2a EMBRACE STEMI, during treatment of a heart attack; intravenous infusion | 0.05 mg/kg/hour for 1 hour | single infusion | 1 hour | [9] |
| Human study | Phase 2 ReCLAIM-2, dry age-related macular degeneration with geographic atrophy; subcutaneous injection | 40 mg | once daily | 48 weeks | [10] |
What the evidence shows
Each finding is tagged by the kind of study it comes from. Human trials are listed first.
Randomized human trial
Barth syndrome, randomized part of TAZPOWER (12 patients): 12 weeks of 40 mg a day did not beat placebo on either primary endpoint, walking distance or fatigue score. [3]
Randomized human trial
The US label says the same of the randomized trial. [1]
Randomized human trial
Primary mitochondrial myopathy, Phase 3 MMPOWER-3 (218 people, 24 weeks): the trial did not meet its primary endpoints. [7]
Randomized human trial
In the earlier 36-person intravenous dose-escalation trial, the highest dose group walked 64.5 m farther after 5 days against 20.4 m on placebo (p = 0.053). [5]
Randomized human trial
MMPOWER-2 (30 people, 4 weeks): the 6-minute walk difference of 19.8 m was not statistically significant. [6]
Randomized human trial
Healthy older adults (39 people aged 60 to 85 with poorly functioning muscle mitochondria): a single 2-hour infusion raised the muscle's capacity to make ATP right after the infusion, with no difference at day 7 and no effect on fatigue resistance. The abstract gives no dose. [13]
Randomized human trial
Heart failure, PROGRESS-HF (71 patients, 28 days): no improvement in left ventricular end systolic volume against placebo. [8]
Randomized human trial
Heart attack, EMBRACE STEMI: a 1-hour infusion did not reduce infarct size. [9]
Randomized human trial
Dry age-related macular degeneration, ReCLAIM-2 (176 patients, 48 weeks): the primary endpoints were not met. [10]
Small human study
Knee extensor strength, the basis of the accelerated approval, did not rise in the randomized trial but rose during the open-label extension, which had no placebo group. [1]
Small human study
In the open-label extension, 6-minute walk distance was better than at the start of the extension at every time point, by 96.1 m at week 168 in the 8 patients who got that far. [4]
Side effects and warnings
Reported in human studies or on a label:
- Injection site reactions are the most common adverse reactions on the label. [1]
- In the Barth syndrome crossover trial the reactions seen more often than on placebo were redness, pain, hardening, itching, bruising and hives at the injection site. [1]
- Eosinophil counts often rose in studies lasting 30 days or more. [1]
- In MMPOWER-2, 80% of participants had injection site reactions on elamipretide, most of them mild. [6]
- In ReCLAIM-2, adverse events were reported by 86% on elamipretide and 71% on placebo. [10]
From the label
- Contraindicated in people with serious hypersensitivity to elamipretide or any ingredient of Forzinity. [1]
- Hypersensitivity reactions, some needing emergency treatment, have been reported. They may occur within minutes to months of starting. [1]
- Contains benzyl alcohol as a preservative (20 mg per mL). Not approved for use in neonates because of the risk of benzyl alcohol toxicity. [1]
- Not approved for intravenous use. [1]
- Dose is reduced in adults with severe renal impairment. The label gives no dose for adults on dialysis or for children with renal impairment. [1]
- Safety and effectiveness are not established in children under 30 kg. [1]
- Missed dose: skip it and take the next dose at the usual time. Do not take a double dose. [1]
- Overdose is expected to cause histamine-type effects such as low blood pressure or near-fainting. [1]
Storage
Refrigerate at 2 to 8 degrees C (36 to 46 degrees F). Do not freeze. After the first dose an opened vial can be kept in the refrigerator or at room temperature, 20 to 25 degrees C (68 to 77 degrees F). Discard vials 8 days after first opening. [1]
SS-31 (elamipretide) dosage questions
How many units is 5 mg of SS-31 (elamipretide) from a 20 mg vial?
Mixed with 2 mL of bacteriostatic water, a 20 mg vial is 10 mg/mL. 5 mg is 0.50 mL, which is 50 units on a U-100 syringe.
How much water goes in a 20 mg SS-31 (elamipretide) vial?
2 mL gives 10 mg/mL. At that strength the doses in the chart sit at 10, 50, 100 units on a U-100 syringe.
How many doses are in a 20 mg vial?
Whole doses in one vial: 20 at 1 mg, 4 at 5 mg, 2 at 10 mg.
Is SS-31 (elamipretide) approved in the US?
FDA approved as Forzinity on 19 Sep 2025, under accelerated approval, to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg.
Is SS-31 (elamipretide) authorized in Canada?
No elamipretide or Forzinity product in the Health Canada Drug Product Database. Health Canada names SS-31 among unauthorized injectable peptide drugs it has seized.
What does the Forzinity label say about dose?
40 mg by subcutaneous injection once daily, at the same time each day. 20 mg once daily for adults with eGFR below 30 mL/minute who are not on dialysis. Vials hold 280 mg in 3.5 mL (80 mg/mL), so 40 mg is 0.5 mL.
Sources
Each one was opened on 10 Oct 2026 and matched to the line it supports.
- Stealth Biotherapeutics Inc. FORZINITY (ELAMIPRETIDE HYDROCHLORIDE) INJECTION [STEALTH BIOTHERAPEUTICS INC.] 2025. dailymed.nlm.nih.gov.
- US Food and Drug Administration Drugs@FDA record for NDA215244, FORZINITY (openFDA) 2025. api.fda.gov.
- Reid Thompson W et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. Genet Med 2021. PubMed 33077895.
- Thompson WR et al. Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER. Genet Med 2024. PubMed 38602181.
- Karaa A et al. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy. Neurology 2018. PubMed 29500292.
- Karaa A et al. A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy. J Cachexia Sarcopenia Muscle 2020. PubMed 32096613.
- Karaa A et al. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology 2023. PubMed 37268435. Trial NCT03323749.
- Butler J et al. Effects of Elamipretide on Left Ventricular Function in Patients With Heart Failure With Reduced Ejection Fraction: The PROGRESS-HF Phase 2 Trial. J Card Fail 2020. PubMed 32068002.
- Gibson CM et al. EMBRACE STEMI study: a Phase 2a trial to evaluate the safety, tolerability, and efficacy of intravenous MTP-131 on reperfusion injury in patients undergoing primary percutaneous coronary intervention. Eur Heart J 2016. PubMed 26586786.
- Ehlers JP et al. ReCLAIM-2: A Randomized Phase II Clinical Trial Evaluating Elamipretide in Age-related Macular Degeneration, Geographic Atrophy Growth, Visual Function, and Ellipsoid Zone Preservation. Ophthalmol Sci 2025. PubMed 39605874. Trial NCT03891875.
- Zhao C et al. Elamipretide: The first cardiolipin-directed mitochondrial therapeutic for Barth syndrome approved under accelerated approval. Drug Discov Ther 2026. PubMed 41260682.
- Tung C et al. Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential. Int J Mol Sci 2025. PubMed 39940712.
- Roshanravan B et al. In vivo mitochondrial ATP production is improved in older adult skeletal muscle after a single dose of elamipretide in a randomized trial. PLoS One 2021. PubMed 34264994.
- Health Canada Think twice before injecting peptides bought online: unauthorized products can seriously harm you 2026. recalls-rappels.canada.ca.
- Health Canada Health Canada Drug Product Database, active ingredient search: elamipretide 2026. health-products.canada.ca.
- World Anti-Doping Agency The Prohibited List 2026. wada-ama.org.
Looked for and not found
- Human half-life: the US label does not state one, and none was found in the trial abstracts, so half_life is left out. The label does say peak levels come 0.5 to 1 hour after a subcutaneous dose, bioavailability is about 92%, and about 100% of a dose is recovered in urine by 48 hours.
- The label has no drug interactions section. Its pharmacology section reports interaction studies with aspirin, clopidogrel and heparin that found no significant effect.
- No Canadian product monograph: nothing is listed in the Health Canada Drug Product Database.
- No trial with an anti-aging, general wellness or athletic outcome was found. The one study in healthy older adults measured muscle energy output after a single infusion and gives no dose in its abstract [13].
- Elamipretide and SS-31 are not named on the WADA Prohibited List (page checked 2026-10-10, [16]).
Change log
10 Oct 2026Page published. 16 sources checked. Vial math added for the 20 mg vial.
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