360 MD Austin
Austin, TX
Physician credentials on file
§ — Substance profile
A
PT-141
Bremelanotide · Vyleesi · Melanocortin receptor agonist
01 — Regulatory status
Regulatory status · United States · as of October 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 October 2026
- Approved drug with randomized controlled trials for the approved indication
- Human clinical data exists, but no approval for the researched use
- Animal or in-vitro data only, no controlled human trials
- No published clinical data; use rests on anecdote
A
B
C
D
Reviewed October 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.
Related substances
07 — Questions for your physician
Six questions worth printing.
- 01What is your primary board certification, and in what year did you obtain it?
- 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?
- 03Which human trials support this use, and what were their size and duration?
- 04Where does the product come from, and can you show me a certificate of analysis for this batch?
- 05What outcome will we measure, when, and what happens if it does not improve?
- 06What is the total cost for the first three months, in writing?
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Every practice in the registry that lists peptide therapy, sorted by distance and nothing else. You contact the practice directly.
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Ahvie Herskowitz, MD · Ann Lee, MD
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Physician credentials on file
Listed for transparency, not as an endorsement of any practice, substance or protocol. Most peptides are not FDA-approved for the uses they are offered for.
Reviewed October 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.