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SS-31: status, evidence, storage and handling

What SS-31 is, the rare disease it's approved for, why longevity use is still unproven, and how gray-market vials differ from the approved drug.

Reviewed October 11, 2026FDA-approved as Forzinity (Rx)Accelerated approval4 min read
What it isMitochondria-targeting tetrapeptide
FDA statusApproved for Barth syndrome only
Human evidenceSmall trials, confirmatory study required
Other usesStill investigational

What SS-31 is

SS-31, now officially named elamipretide, is a four amino acid peptide that concentrates in the inner membrane of mitochondria, the cell's energy producers. It binds cardiolipin, a fat that holds the energy-making machinery together.

In September 2025 it became the first FDA-approved drug that targets mitochondria, for a very rare genetic disease. It's also sold online as a longevity and energy peptide. Those are two very different uses.

BrandForm and approved use
Forzinity

Daily injection. Accelerated approval to improve muscle strength in people with Barth syndrome who weigh at least 30 kg (about 66 lb).

Regulatory status in 2026

Elamipretide is approved only as Forzinity, for Barth syndrome, under accelerated approval. Gray-market SS-31 is not Forzinity.

  1. An FDA advisory committee votes 10 to 6 that elamipretide is effective for Barth syndrome, despite FDA staff doubts.

  2. FDA grants accelerated approval to Forzinity for Barth syndrome.

  3. A confirmatory randomized trial is required to keep the approval. Other uses, such as mitochondrial myopathy and macular degeneration, are still in trials.

Regulatory status can change. Check the sources linked at the bottom of this page before relying on anything here.

What's proven vs. what's claimed

The approval rests on a small number of patients with a rare disease. That's very different from evidence for healthy people.

Common claim

Improves muscle strength in Barth syndrome.

What the evidence shows

Basis for accelerated approval, from a small trial and long extension study. A confirmatory trial is required.

Strong human evidence
Common claim

Boosts energy and slows aging in healthy people.

What the evidence shows

Not established in human trials.

Insufficient data
Common claim

Gray-market SS-31 is the same as Forzinity.

What the evidence shows

Not evaluated by FDA for quality, strength, or purity.

Insufficient data

Storage and stability

Forzinity has its own label storage instructions. Gray-market vials have no validated storage data, so general peptide handling applies.

Forzinity (brand)

  • Store exactly as the label and pharmacist direct.
  • Keep in the original carton.
  • Don't use past the expiration date.

Gray-market SS-31

  • Keep refrigerated. Do not freeze.
  • Protect from light. Clear glass lets it through.
  • Opened multi-dose bacteriostatic water is typically discarded 28 days after first puncture.
  • Log the mix date so you know the vial's age at a glance.

Light exposure is easy to overlook in a fridge door that opens dozens of times a day. VIALTIGHT is building stackable cases that block light from every side. See vialtight.com for updates.

Safety flags

Injection site reactions. Mild to moderate injection site reactions were the most common side effect in trials. Serious reactions were also reported.

Approval may change. Accelerated approval depends on a confirmatory trial. Results could change the label.

Product quality is unverified. Gray-market vials have been found underdosed, mislabeled, or contaminated. A certificate of analysis from the seller is not the same as independent testing.

FAQ

Is SS-31 the same as elamipretide?

Yes. SS-31 was the research name. Elamipretide is the official drug name, and Forzinity is the brand.

Can I get Forzinity for longevity?

It's approved only for Barth syndrome. Use for anything else is off-label and unproven.

Does VialTracker tell me what to take?

No. VialTracker organizes the information you enter and runs the math. It does not recommend doses, products, or protocols.

Sources

  1. DailyMed: Forzinity prescribing information

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