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Research snapshot · Nov 11, 2026
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One rare-disease approval does not validate gray-market use — editorial cutaway illustration of a
Illustrative stock photo — the people pictured are models, not patients, clinicians, endorsers, or cases from our reporting.
FORZINITY / SS-31

One rare-disease approval does not validate gray-market use

Edited by Samael A. Tejada, Founder & Editor-in-Chief

Status reviewed

Elamipretide’s accelerated approval is limited to Barth syndrome; prior primary-mitochondrial-myopathy endpoints were not met. Compounded SS-31 is not approved.

Approval history ↗

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