The Longevity Registry

§ — Substance profile

A

PT-141

Bremelanotide · Vyleesi · Melanocortin receptor agonist

01 — Regulatory status

Regulatory status · United States · as of September 2026

FDA-approved (Vyleesi) for hypoactive sexual desire disorder in premenopausal women. Use in men or for other purposes is off-label.

Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026

A
Approved drug with randomized controlled trials for the approved indication
B
Human clinical data exists, but no approval for the researched use
C
Animal or in-vitro data only, no controlled human trials
D
No published clinical data; use rests on anecdote

Reviewed September 2026 · Sources: FDA, EMA

02 — Researched for

What is being studied.

Hypoactive sexual desire disorder in women; erectile dysfunction in men (earlier programs).

03 — What the evidence shows

The published record.

Two phase 3 trials showed a modest increase in desire scores and a small reduction in distress versus placebo in the approved population.

04 — What is claimed but not shown

Claimed, not demonstrated.

Reliable effect in men; benefit in postmenopausal women; performance enhancement.

05 — Known risks

Documented risks.

Nausea in about 40% of users, flushing, transient blood pressure rise, focal hyperpigmentation with repeated use.

06 — Researched for these goals

Where PT-141 appears.

07 — Questions for your physician

Six questions worth printing.

  1. 01What is your primary board certification, and in what year did you obtain it?
  2. 02Is this peptide approved for what you are prescribing it for — and if not, what is the legal basis on which you are supplying it?
  3. 03Which human trials support this use, and what were their size and duration?
  4. 04Where does the product come from, and can you show me a certificate of analysis for this batch?
  5. 05What outcome will we measure, when, and what happens if it does not improve?
  6. 06What is the total cost for the first three months, in writing?

Reviewed September 2026 · Sources: FDA, EMA

This page reports on the state of research and regulation for orientation. It is not medical advice, not a recommendation for or against any substance, and not an offer. Regulatory status changes; the date shown is the date of our last verification. Discuss any treatment with a licensed physician.