Longevity / Published Sep 8, 2026 / Reviewed Sep 27, 2026 / 7 min read
SS-31 and Elamipretide: What the Forzinity Approval Does and Does Not Mean
Written by Aaron CuhaReviewed Sep 27, 2026
Elamipretide (SS-31) became the first FDA-approved peptide aimed at mitochondria in September 2025, for one rare disease. What the approval covers, what the studies in people showed, and why it says nothing about the 'research' SS-31 sold online. Plain English.
Key takeaways
- Elamipretide (Forzinity) got fast-track FDA approval on September 19, 2025 for Barth syndrome, in patients weighing 30 kg or more. The approval was based on thigh muscle strength, and the FDA wants a follow-up study to confirm it.
- SS-31 is the research name for the same small peptide, four building blocks long. It sticks to cardiolipin, a fat in the inner wall of mitochondria, the cell's power plants, and helps keep the energy-making machinery in shape.
- The approval covers one very rare disease. It does not cover longevity, tiredness, sports performance or heart failure. In some of those, elamipretide already failed, and the rest are still being tested.
- Big final-stage studies are still going in dry macular degeneration, an eye disease of aging, and in a mitochondrial muscle disease.
- A vial labeled SS-31 from a gray-market seller is not Forzinity. It is made differently, nobody checks what is in it or how pure it is, and it has no legal status.
Is SS-31 FDA approved?
Direct answer
Elamipretide, the drug form of SS-31, got fast-track FDA approval on September 19, 2025 as Forzinity. It is for Barth syndrome, a rare mitochondrial disease, in patients over 30 kg. The approval rests on muscle strength, and the FDA wants a follow-up study to confirm it. It does not cover longevity, tiredness or the 'research' SS-31 sold online.
Elamipretide is a good example of how marketing stretches a real approval. The molecule (D-Arg-dimethylTyr-Lys-Phe-NH2) was designed by Hazel Szeto and Peter Schiller in the early 2000s, one of a series of 'SS' peptides that build up in mitochondria. Stealth BioTherapeutics developed it as elamipretide. Our profile is at elamipretide.
How elamipretide works
Cardiolipin is a fat found almost only in the inner wall of mitochondria. It holds the energy-making machinery in working shape. In disease and aging, cardiolipin gets damaged and the machinery works less well. It leaks electrons, which turn into harmful molecules (reactive oxygen species). Elamipretide sticks to cardiolipin, helps the wall keep its shape, and helps the cell make more energy with less leaking (PMC9192202). It is not an antioxidant like a vitamin. It works on the machinery that makes the harmful molecules.
Barth syndrome is caused by changes in a gene called TAZ that stop cardiolipin from being put together properly. So it is the cleanest test of how the drug works. That is why the approval came there first.
What the FDA approval covers
| Use | Status | What it rests on |
|---|---|---|
| Barth syndrome (30 kg and over) | Fast-track approval, Sept 19, 2025 (Forzinity) | TAZPOWER study and its open follow-on; thigh muscle strength; a follow-up study is required |
| Mitochondrial muscle disease (primary mitochondrial myopathy) | Still being tested (an earlier big study failed) | MMPOWER-3 missed its main goals |
| Dry macular degeneration | Big final-stage study (ReNEW) | A hint in a mid-sized study (ReCLAIM-2) on one layer of the retina |
| Heart failure | No active program | Earlier studies failed |
| Longevity, tiredness, performance | Never studied for approval | No study |
The FDA's announcement is here: FDA grants accelerated approval to first treatment for Barth syndrome. Fast-track (accelerated) approval means the FDA accepted a stand-in measure, here muscle strength, on the condition that another study confirms real benefit. If it doesn't, the approval can be pulled.
Why the gray-market SS-31 is not Forzinity
Direct answer
Forzinity is made to drug-factory standards, with its identity, purity and sterility checked. It is prescribed for one disease and watched. Research SS-31 vials have none of that. No regulator has checked what is in them. The FDA's July 2026 review of similar products found lab certificates that did not match the label. And no approval covers using them.
To learn what a lab certificate can and cannot tell you, read our guide on how to read a peptide COA.
Should you take MOTS-c and SS-31 together?
Direct answer
No study has tested the pair. Outside elamipretide's rare-disease program, neither peptide has a finished study in people showing it works. The 'SS-31 first, then MOTS-c' plans shared online are opinions, not plans from any study. The only reason people pair them is that both have to do with mitochondria.
For what MOTS-c has and has not shown, see MOTS-c: the mouse data and the one human trial.
Can SS-31 reverse aging?
Direct answer
No study in people has tested it in healthy older adults for anything to do with aging. The studies in people that exist are about rare diseases and eye disease. 'Reverses aging' is not a claim any published data backs up. In short studies in old mice, elamipretide improved how mitochondria worked, how the heart pumped and how much exercise they could do.
What to watch
- The follow-up Barth syndrome data the fast-track approval requires.
- Results from the big ReNEW study in dry macular degeneration. That would be the first common disease it is approved for.
- Whether the FDA's 2026 pharmacy reviews ever take up elamipretide. They have not; it was not on the July 2026 agenda.
Frequently asked questions
What are the benefits of SS-31?
In the approved use, better muscle strength in Barth syndrome. For general health or aging, no benefit in people has been shown. In animals, mitochondria worked better in several organs.
Can SS-31 help with weight loss?
No study has tested it for weight. It does not work on appetite or on how much energy the body burns.
Is SS-31 safe?
Forzinity's label lists reactions where you inject as the most common side effect in its studies. Gray-market SS-31 has no safety data, and nobody checks its quality.
How long do you take SS-31 before MOTS-c?
No study has tested either order, or the pair. There is no evidence-based answer.
Compound profiles mentioned
- ElamipretideModerate. At least one finished study in people, and at least 100 people who took it. 5 completed trials, 487 people given it.Anti-aging
- MOTS-cLimited. People have taken it in a published study, but fewer than 100 of them. 1 completed trial, 30 people given it.Longevity
- SkQ1Preliminary. Studied in people, but no published study has had people take it. 1 human study where nobody was given it.Antioxidant
- Methylene BlueLimited. People have taken it in a published study, but fewer than 100 of them. 1 completed trial, 26 people given it.Antioxidant
- NAD+Limited. People have taken it in a published study, but fewer than 100 of them. 1 completed trial, none stating how many people.Longevity
Sources
- Study in people2025
FDA grants accelerated approval to first treatment for Barth syndrome
Approved based on muscle strength; a follow-up study is required.
FDA press release - Study in people2023
Efficacy and safety of elamipretide in individuals with primary mitochondrial myopathy: the MMPOWER-3 randomized clinical trial
A big final-stage study, and it missed both of its main goals. The journal rates it as top-grade (Class I) evidence of no effect. That is stronger than just a failed study: it is evidence that the drug does not work for this disease at this dose.
Neurology - Study in people2025
ReCLAIM-2: a randomized phase II clinical trial evaluating elamipretide in age-related macular degeneration, geographic atrophy growth, visual function, and ellipsoid zone preservation
A mid-sized study in late-stage dry macular degeneration. The good sign was on keeping one layer of the retina (the ellipsoid zone), not on the main goal of slowing the damaged patch's growth. That difference matters when people call this study a success.
Ophthalmology Science - Review of studies2026
Elamipretide: first approval
A summary of the approval and how the drug was developed.
Drugs (PubMed 41335372) - Review of studies2022
Elamipretide and cardiolipin: mechanism review
Sticks to cardiolipin and helps mitochondria make energy with less leaking.
PubMed Central PMC9192202
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Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.