U.S. regulatory status
SS-31 (elamipretide)
Also known as Elamipretide, Elamipretide hydrochloride, Forzinity, MTP-131, Bendavia
Is SS-31 (elamipretide) legal right now?
SS-31 is the code name for elamipretide, a synthetic peptide that its FDA label describes as a mitochondrial cardiolipin binder.
In the United States it is a prescription-only drug: on September 19, 2025 the FDA granted accelerated approval to Forzinity (elamipretide hydrochloride injection, Stealth BioTherapeutics) for patients with Barth syndrome who weigh at least 30 kg. Compounding is narrow.
Because elamipretide hydrochloride is a component of an approved drug, a state-licensed 503A pharmacy may compound with it for an individual patient’s prescription, but not regularly or in large amounts as essentially copies of Forzinity. That does not cover the acetate salt: in a December 2025 warning letter the FDA listed elamipretide (SS-31) acetate among substances ineligible for 503A compounding, and on August 24, 2026 it told four online sellers that their SS-31 products are unapproved new drugs.
Elamipretide is not on any of the FDA’s 503A category lists. The approval is conditional: Stealth must run a confirmatory trial, and the FDA can withdraw the approval if that trial fails to verify clinical benefit.
Restricted: Prescription-only, banned, controlled, or under active FDA enforcement.
Verified Oct 15, 2026 (ET) · status held since Sep 19, 2025
Where it sits in the process
Outside the 503A list process. It is an FDA-approved drug, so the 503A bulks list does not apply to it. The status above says what pharmacies may and may not do.
What changed last
No recorded changes yet - this entry has held one status since it was added.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | Restricted | FDA-approved prescription drug: Forzinity (elamipretide hydrochloride) injection, NDA 215244, accelerated approval Sep 19, 2025. As a component of that drug, the HCl salt may be 503A-compounded for an individual patient, but not regularly or in inordinate amounts as essentially copies of Forzinity. FDA has called elamipretide (SS-31) acetate ineligible for 503A compounding (Dec 2025 warning letter). Not on any 503A category list. |
| Australia (TGA) | Unscheduled | Not individually named in the Poisons Standard (October 2026) and no product on the ARTG; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides. |
| United Kingdom (MHRA) | Restricted | No UK marketing authorisation (no result for elamipretide in the MHRA products database); supply as a medicine is unlicensed. |
| European Union (EMA) | Restricted | No EU marketing authorisation. Holds EU orphan designations for Barth syndrome (May 20, 2021) and myopathic mitochondrial DNA depletion syndrome (May 16, 2022), which EMA says do not mean the medicine is authorised. |
| Canada (Health Canada) | Restricted | Not in the Drug Product Database; Health Canada’s Apr 9, 2026 advisory names SS-31 among unauthorized injectable peptide drugs it has seized. |
| Sport / anti-doping (WADA) | Unscheduled | Not named on the 2027 Prohibited List. S0 covers only substances with no current government approval for human therapeutic use, and elamipretide has been FDA-approved since Sep 2025. |
The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it
FDA warning letters
5 FDA warning letters mention SS-31 (elamipretide), from Dec 8, 2025 to Aug 24, 2026.
- Peak Performance Peptides
- Peptide Partners LLC
- Royal Peptides LLC
- TXP Innovations LLC dba Tex Peptides
- Darmerica, LLC
A warning letter is the FDA telling one company it believes the company broke federal law. It does not change the status above. All warning letters, by compound
Sources & transparency
Sources for this entry
- FDA press release - FDA grants accelerated approval for first treatment for Barth syndrome (Sep 19, 2025) FDA · primaryForzinity (elamipretide) injection, Stealth BioTherapeutics; patients weighing at least 30 kg; confirmatory trial required as a condition of accelerated approval.
- Drugs@FDA - NDA 215244 (Forzinity) FDA · primaryElamipretide hydrochloride, subcutaneous solution, marketing status Prescription; original approval 09/19/2025 (priority, orphan).
- FDA - Bulk drug substances used in compounding under section 503A FDA · primary503A pharmacies may use bulk substances that are components of FDA-approved drug products when no USP/NF monograph exists.
- FDA warning letter - Darmerica, LLC (Dec 8, 2025) FDA · primaryLists elamipretide (SS-31) acetate among APIs ineligible for use in human drug compounding under section 503A.
- FDA warning letter - Royal Peptides LLC (Aug 24, 2026) FDA · primaryOne of four Aug 24, 2026 letters naming “SS-31 (Elamipretide)” as an unapproved new drug; the others went to Peptide Partners LLC, TXP Innovations LLC dba Tex Peptides and Peak Performance Peptides.
- TGA - Responsibilities when importing, compounding and supplying unapproved peptide products (Apr 13, 2026) TGA · primaryBasis for the Australia (TGA) row: unapproved peptide products are goods not included in the ARTG.
- MHRA Products database - search: elamipretide UK gov · primaryBasis for the United Kingdom (MHRA) row: no search results.
- EMA - Orphan designation EU/3/21/2430, elamipretide for Barth syndrome EU · primaryBasis for the European Union (EMA) row: designated May 20, 2021; orphan designation does not mean the medicine is authorised.
- Health Canada - Think twice before injecting peptides bought online (Apr 9, 2026) Health Canada · primaryBasis for the Canada (Health Canada) row: SS-31 is listed among unauthorized injectable peptide drugs seized.
- WADA - 2027 Prohibited List (in force Jan 1, 2027) WADA · primaryBasis for the Sport row: elamipretide is not named; S0 applies only to substances with no current government approval for human use.
- Last verified by a human
- Oct 15, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
- What we sell
- Nothing. No products, no affiliates, no sponsored placements.
This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.
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