KPV official evidence assessment · version 1
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What does the official evidence assessment say?
FDA assessment dated May 12, 2026 · Read September 15, 2026 · Preserved version 1
FDA's assessment of KPV free base and KPV acetate for the nominated uses of wound healing and inflammatory conditions. The assessment was prepared for the July 2026 Pharmacy Compounding Advisory Committee meeting. FDA document ↗
What did FDA find about human studies?
FDA reported that its search did not identify studies of KPV administered to humans. It concluded that evidence was insufficient to evaluate effectiveness for the nominated uses. FDA pp. 20, 21 ↗
Why human skin research is different
FDA identified a skin-permeation study using human cadaver skin among the nomination references. That is not a study of KPV treatment in living participants. FDA pp. 20 ↗
What is known about harms?
FDA reported no identified human pharmacokinetic studies or clinical safety studies. Its adverse-event searches through December 3, 2025 did not identify qualifying reports; the agency states that potential safety risks in humans are unknown. FDA pp. 25, 26 ↗
Scope, source pin and remaining work
This summarizes the agency's dated assessment. It is not an independent claim that no evidence exists worldwide or that the briefing is a final regulatory decision. Newer reports and formulation identities require separate screening.
Source: FDA briefing document for KPV. SHA-256: 0253b86534700fc72a48cccab7b10c19201102da831ef7a8a28e8dab09fea254.