Peptide Regulation Watch · Substance File
Bremelanotide
Legal Rx
STATUS VERIFIED AUGUST 22, 2026 · HAS A SHELF LIFE
The FDA-approved melanocortin agonist — lawful with a valid prescription, through licensed channels.
Also encountered as: Bremelanotide · Vyleesi · PT-141 (approved) · class: approved peptide drug
Where it actually stands
This is an FDA-approved drug — lawful with a valid prescription, through licensed channels. It appears in this registry because its name circulates in compounding and gray-market contexts where the approved product and unapproved copies get conflated. The approval covers the approved product, its approved uses, and licensed distribution — nothing else.
The one-sentence version: approved and lawful by prescription through licensed channels; the approval does not extend to copies.
The record
AUG 9, 2026
Approved status confirmed for the Q3 2026 brief.
Primary sources
FDA approved drug listings · Q3 2026 brief verification. Full citation list available on request.