Regulation

Compounding rules tighten around SS-31

A close reading of the SS-31 evidence, without the marketing layer.

Compounding rules tighten around SS-31

SS-31 is a mitochondria-targeting tetrapeptide with a development status of "phase 3 clinical trials". The Institute rates the strength of its published evidence as moderate. A cardiolipin-binding tetrapeptide studied in primary mitochondrial myopathy and Barth syndrome.

Commercial availability of SS-31 continues to run ahead of its regulatory status. That is the recurring structural feature of this market: demand arrives when trial data is published, and supply arrives from channels that answer to nobody in particular.

Our position on developments like this is consistent. We report what changed, we test what is being sold, and we decline to speculate about what a regulator will do next.

The Institute has independently tested 2 SS-31 samples from 2 companies. 100% met their label claims on purity and content. Measured purity ranged from 97% to 97.7%, averaging 97.4%. Every specimen is published in full, including the laboratory that ran it.

The Peptide Institute is an independent research institute. We do not sell products, we do not accept vendor sponsorship, and we publish results that reflect badly on companies as readily as results that do not.

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