# Elamipretide

Four amino acids that lodge in the inner membrane of mitochondria and steady a fat molecule called cardiolipin. In 2025 it won its first approval, for one ultra-rare disease. Online it is sold as SS-31 for energy and anti-aging.

Also called: SS-31, Forzinity, Bendavia
Source page: https://peplogue.com/peptides/elamipretide/
Reviewed: 2026-10-12. Not medical advice.

## How it works

- Where it acts: Cardiolipin, a fat molecule in the inner membrane of mitochondria.
- What it changes: It steadies the machinery that makes the cell's energy.
- What people notice: In Barth syndrome, gains in knee muscle strength in an open-label extension, though the short controlled trial missed its main goals. Injection-site reactions are very common.

## What the evidence shows

- **Muscle strength in Barth syndrome**: Proven. US accelerated approval in September 2025 for patients weighing at least 30 kg. The 12-patient trial missed its main goals; approval rests on knee strength gained in an open-label extension. A confirmatory trial is running.
- **Primary mitochondrial myopathy**: Failed. A phase 3 trial missed its goals in 2019. The company is now pursuing one genetic subtype.
- **Dry age-related macular degeneration**: Early. A phase 2 trial missed its main goals but showed signals worth following. A fully enrolled phase 3 trial reports in late 2027.
- **Energy and anti-aging in healthy people**: Lab only. Not studied.

## Side effects and risks

- common: Injection-site reactions in every patient in the trial.
- serious: Allergic reactions have occurred.
- unknown: Tested in very few people.

Who should avoid it: Newborns (the product contains benzyl alcohol), and anyone buying SS-31 online for energy.

## How it is taken

A 40 mg injection under the skin once a day, or 20 mg with severely reduced kidney function.

## Legal status

- United States: undefined. Forzinity, for Barth syndrome only.
- European Union: undefined. No EU authorization found.
- Spain: undefined. No elamipretide medicine in CIMA, so it is not authorised in Spain. Not lawful to sell to the public.
- Germany: undefined. No German or EU approval known (US-approved). A pharmacy may import it for one named patient on prescription (§ 73 Abs. 3 AMG).
- France: undefined. Not authorised in France. ANSM lists a compassionate-use authorisation (AAC), ongoing at its Dec 2025 update. Online offers are illegal.
- Italy: undefined. No EU or Italian authorisation found; approved in the US only. Not available in Italy outside a clinical trial.
- Netherlands: undefined. No Dutch or EU marketing authorisation found (Forzinity is a US product). Online sale is sale of an unlicensed medicine.
- United Kingdom: undefined. No UK license found.
- Canada: undefined
- Australia: undefined

## Questions people ask

**What is elamipretide approved for?**

Muscle strength in Barth syndrome, sold as Forzinity for patients weighing at least 30 kg. It received US accelerated approval in September 2025; the 12-patient trial missed its main goals, and approval rests on knee strength gained in an open-label extension.

**Does SS-31 work for energy or anti-aging?**

This has not been studied in healthy people. Gray-market users report more stamina, but those reports are very few.

**What are the side effects of elamipretide?**

Injection-site reactions occurred in every patient in the trial, and allergic reactions have occurred. It has been tested in very few people.

**Is SS-31 legal?**

In the US it is approved only as Forzinity for Barth syndrome, and FDA named SS-31 in warning letters to research-use-only sellers in August 2026. No EU authorization or UK license was found.

## Sources

- Forzinity US prescribing information (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=146bf34c-76f2-48db-ac07-fb29cce2cd75
- Stealth BioTherapeutics: pipeline update (6 Jan 2026): https://www.biospace.com/press-releases/stealth-biotherapeutics-provides-commercial-and-r-d-pipeline-update-and-outlines-2026-strategic-priorities
- Mighty Therapeutics: confirmatory study begins (8 Jul 2026): https://www.biospace.com/press-releases/mighty-therapeutics-announces-first-patient-dosed-in-phase-4-confirmatory-study-of-elamipretide-in-barth-syndrome