Repair & mitochondrial
Tissue-repair claims, cellular stress signaling, and mitochondrial research candidates.
Questions
What does the Repair and mitochondrial category cover?
The sampled monographs span mitochondrial-targeting elamipretide, mitochondrial-derived MOTS-c and humanin, unapproved repair candidate BPC-157, and thymosin alpha-1. The category groups related research themes for navigation and does not imply shared mechanisms, evidence, or authorization.
Which sampled Repair and mitochondrial entries have documented approvals?
Elamipretide has an FDA accelerated approval for a specific Barth syndrome indication. Thymosin alpha-1 has reported national authorizations outside the United States but no FDA or centralized EMA approval. BPC-157, MOTS-c, and humanin have no approved products identified in their reviewed US and EU records.
What evidence supported elamipretide's accelerated approval?
The monograph reports that FDA accelerated approval relied on an intermediate clinical endpoint, knee extensor muscle strength, in Barth syndrome and requires a confirmatory study. That decision supports only the named indication; other elamipretide uses remain investigational.
What human evidence exists for MOTS-c and humanin?
MOTS-c has observational human evidence linking circulating levels with metabolic measures and was in clinical development at review. Humanin has extensive preclinical research but no published human intervention trial of exogenous humanin or its potent analogue. Neither has an established or recommended human dose.
Why should BPC-157 not be described as a proven repair treatment?
BPC-157 has extensive preclinical literature but only three small human pilot studies in the reviewed monograph, and no regulator has approved it for an indication. WADA lists it under the non-approved-substances class. These facts do not establish therapeutic efficacy or safety.
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