Is MOTS-c with SS-31 legal in the United States?

Two mitochondrial peptides sold as one stack. SS-31 is elamipretide, which reached phase 3 in primary mitochondrial myopathy and did not demonstrate a significant benefit in its overall trial population. MOTS-c has no human trial at all. The combination has never been studied and vendors do not agree on vial sizes.

This pairing is sold to people with fatigue, and the two halves have very different evidentiary situations that get flattened into one product page. SS-31 is elamipretide, a real investigational drug that went through a proper development programme.

Mechanism: SS-31 is an aromatic cationic tetrapeptide that binds cardiolipin in the inner mitochondrial membrane and is described as stabilising membrane structure and improving electron transport efficiency. MOTS-c is encoded in mitochondrial DNA and is described as activating AMPK and regulating metabolic pathways.

Regulatory history: Neither is approved. Elamipretide has been through phase 3 development without an approval for this indication; MOTS-c has never entered clinical development.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for MOTS-c with SS-31 at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.