Peptide Regulation Watch · Substance File

PT-141 (compounded)

Not Listed STATUS VERIFIED AUGUST 22, 2026 · HAS A SHELF LIFE

Compounded forms of the melanocortin receptor agonist bremelanotide — compounded today under enforcement discretion, not approval.

Also encountered as: PT-141 · bremelanotide (compounded) · class: sexual health

Where it actually stands

Industry summaries routinely place this substance in FDA's interim Category 1. Checked against FDA's own 503A nominations list (updated 5/14/26), it does not appear there — in any category. No enforcement-discretion assurance attaches to a substance that is not on the list. Anyone quoting Category 1 status for this substance is citing a secondary source; verify against FDA's current list before any formulary decision.

The one-sentence version: not on FDA’s list — the Category 1 status widely attached to this substance does not match the record.

The record

APR 22, 2026

FDA's bulk substances / safety-risk category pages last updated — the placement behind this status.

AUG 9, 2026

Status verified against the category pages for the Q3 2026 brief. Re-verify before acting — interim placements move.

Primary sources

FDA bulk substances / safety-risk pages (updated 4/22/26) · industry compounding summaries, cross-checked for the Q3 2026 brief. Full citation list available on request.