Bremelanotide (PT-141)

Main evidence: Human clinical trials. Updated 2026-10-28.

What research and users report, not a recommendation or medical advice. Many of these products are not approved for human use. Ask your doctor. Packs report what sources say, each with its evidence label. A claim labelled community, educator, manufacturer or animal has not been validated in humans.

Summary

This draft distinguishes the approved HSDD indication from investigational and unverified performance claims.

What the sources say

Two randomized phase 3 trials found statistically significant but modest improvements in desire and distress scores compared with placebo; the integrated between-group changes were 0.35 on the desire measure and −0.33 on the distress measure. The study population was predominantly U.S.-based and White. (Human clinical trials; Kingsberg et al., "Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials," Obstetrics & Gynecology, 2019-10-10)
The U.S. label indicates bremelanotide for premenopausal women with acquired, generalized hypoactive sexual desire disorder that causes distress or interpersonal difficulty. It is not indicated for men, postmenopausal women, or sexual-performance enhancement. (Manufacturer information; DailyMed, VYLEESI (bremelanotide) injection: Prescribing Information; label record updated 2025-11-13, 2025-11-13)
A phase 2 study of bremelanotide with a PDE5 inhibitor was announced for men with erectile dysfunction not responding to PDE5 inhibitors. The announcement describes an investigational combination study, not a demonstrated outcome or evidence for the approved HSDD indication. (Manufacturer information; Palatin Technologies, "Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5i for the Treatment of Erectile Dysfunction", 2024-06-20)
The label contraindicates use in uncontrolled hypertension or known cardiovascular disease. It reports transient blood-pressure increases and heart-rate decreases after dosing, and focal hyperpigmentation, with greater risk reported in darker skin and with more frequent dosing. (Manufacturer information; DailyMed, VYLEESI (bremelanotide) injection: Prescribing Information; label record updated 2025-11-13, 2025-11-13)
Nausea was reported by 40% of treated patients in the phase 3 program, compared with 1.3% on placebo in the label summary; it led to premature discontinuation for about 8% of treated patients. Other common reactions included flushing, injection-site reactions, headache, and vomiting. (Manufacturer information; DailyMed, VYLEESI (bremelanotide) injection: Prescribing Information; label record updated 2025-11-13, 2025-11-13)
The label warns that bremelanotide may slow gastric emptying and reduce absorption of oral medicines; it specifically advises avoiding oral naltrexone products intended for alcohol or opioid addiction because systemic naltrexone exposure may be reduced. (Manufacturer information; DailyMed, VYLEESI (bremelanotide) injection: Prescribing Information; label record updated 2025-11-13, 2025-11-13)
No public ARTG entry for bremelanotide, PT-141, or Vyleesi was located in the search reviewed on 2026-10-28. This is a negative public-register search, not a definitive ruling on every possible exemption or access pathway. (Educator material (not peer reviewed); Therapeutic Goods Administration, Searching the Australian Register of Therapeutic Goods; checked 2026-10-28, 2026-10-28)
The October 2026 Poisons Standard is the current instrument reviewed, but this draft does not assign a bremelanotide-specific Schedule because a substance-specific classification was not verified in the materials reviewed. (Educator material (not peer reviewed); Federal Register of Legislation, Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, 2026-09-30)

Sources

Dosing, stacking and protocol details are not published here.