Previously in Part I
We established the regulatory framework (Category 1 ≠ FDA approved), the Phase 1/2/3 evidence standard, and reviewed the 7 peptides with at least some human trial data — including the one FDA-approved compound (PT-141) and the one that completed Phase 3 and failed (AOD-9604). Read Part 1 here →
Clinical Takeaway — Part II
The Compounds Where the Evidence Gets Thin — Fast
Tiers IV and V contain 10 of the 17 peptides. Of those, 5 have zero published human trials of any phase—they are being prescribed based entirely on animal data.
BPC-157, the most hyped compound on the list, has approximately 30 human subjects across all published research — no randomized trials, a canceled Phase 1 with no published results.
Melanotan II is the compound where the FDA's concern is most defensible: melanoma case reports, cardiovascular events, and no Phase 3 data.
RFK Jr.'s procedural argument may have legal merit. Winning it does not make any of these compounds safe or effective. The evidence base is unchanged by the reclassification.