# SS-31

elamipretide · Forzinity · MTP-131 · Bendavia

https://graded.pl/en/substances/ss-31 · Checked: Not yet

Preliminary version. The editors have not finished checking this card, and grades may change.

A peptide that acts in mitochondria, the power plants of cells. Approved in the US on a fast track as Forzinity for Barth syndrome, a rare genetic disease. Not approved in the EU.

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## Short answers

### Does SS-31 work?

A peptide that acts in mitochondria, the power plants of cells. Approved in the US on a fast track as Forzinity for Barth syndrome, a rare genetic disease. Not approved in the EU. Strength: grade C, conflicting results. A large study in a rare muscle disease found no improvement, after small studies gave unclear results. The FDA approved it on a fast track to improve muscle strength in Barth syndrome, another rare disease. None of this concerns healthy people.

### Is SS-31 legal?

PL: No approval. The European medicines database (EMA) lists no such medicine in Poland (9 October 2026). The Polish register was down, so we could not check it directly. EU: No approval. The European medicines database (EMA), which covers EU and national approvals, lists no such medicine (9 October 2026). US: Prescription only. Prescription medicine (Forzinity).

### Is SS-31 banned in sport?

Not on the list, WADA 2026.

### Is SS-31 safe?

Little data. The US label covers a rare disease, Barth syndrome, and warns that benzyl alcohol in the product can harm newborns. In long follow-up, reactions at the injection site were the most common problem.

## What studies show

| | | | |
|---|---|---|---|
| Strength | C | Conflicting results | A large study in a rare muscle disease found no improvement, after small studies gave unclear results. The FDA approved it on a fast track to improve muscle strength in Barth syndrome, another rare disease. None of this concerns healthy people. |

## Studies we have read

- Long-term efficacy and safety of elamipretide in patients with Barth syndrome: 168-week open-label extension results of TAZPOWER. (Genetics in medicine : official journal of the American College of Medical Genetics 2024; No random groups, n=10) https://pubmed.ncbi.nlm.nih.gov/38602181/
- Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. (Neurology 2023; Random groups) https://pubmed.ncbi.nlm.nih.gov/37268435/
- A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy. (Journal of cachexia, sarcopenia and muscle 2020; Random groups, n=30) https://pubmed.ncbi.nlm.nih.gov/32096613/
- Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy. (Neurology 2018; Random groups, n=36) https://pubmed.ncbi.nlm.nih.gov/29500292/

## Is it legal

- PL: No approval. The European medicines database (EMA) lists no such medicine in Poland (9 October 2026). The Polish register was down, so we could not check it directly. https://www.ema.europa.eu/en/documents/other/article-57-product-data_en.xlsx (Checked: Not yet)
- EU: No approval. The European medicines database (EMA), which covers EU and national approvals, lists no such medicine (9 October 2026). https://www.ema.europa.eu/en/documents/other/article-57-product-data_en.xlsx (Checked: Not yet)
- US: Prescription only. Prescription medicine (Forzinity). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215244 (Checked: Not yet)

## Doping

Not on the list, WADA 2026. https://zoek.officielebekendmakingen.nl/trb-2026-25.html

## How much research exists

- Scientific papers: 472
- Studies with random groups: 19
- Registered studies in people: 29
- These are search results. A count shows how much exists, not how good the studies are. 1 Nov 2026.

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Open data: CC BY 4.0, https://creativecommons.org/licenses/by/4.0/