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Sexual health

PT-141 (Bremelanotide)

Not authorized in Canada (approved elsewhere) Evidence 3/4
PT-141 peptide structure illustration (abstract amino-acid chain)
In short

A melanocortin-receptor drug approved by the FDA in 2019 as Vyleesi for low sexual desire in premenopausal women. We found no bremelanotide product in Health Canada's Drug Product Database.

Reviewed November 10, 2026 · 4 sources cited below

Also known asVyleesi (US)
CategorySexual health
Canada statusNot authorized in Canada (approved elsewhere)
Human evidence Moderate: some randomized human trials, specific uses (small effects)
Last reviewedNovember 10, 2026

How strong is the human evidence?

Moderate: some randomized human trials, specific uses (small effects). How we rate evidence

What is PT-141?

Bremelanotide (PT-141) activates melanocortin receptors in the brain.

The FDA approved Vyleesi (bremelanotide injection) on June 21, 2019, for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Is PT-141 legal in Canada?

Not authorized: no bremelanotide product found in the Drug Product Database (Nov 10, 2026). "PT-141" sprays or vials sold online are unauthorized.

See how Health Canada regulates peptides.

What the research shows

  • RECONNECT Phase 3 trials (Kingsberg et al. 2019; 1,267 women randomized): statistically significant but small improvements in desire and distress scores vs placebo.

What it doesn't show

  • The approval covers premenopausal women with HSDD, not men or general libido enhancement.
  • A 2024 critical analysis argued the benefits were modest and some outcome measures had limited validity (Spielmans & Ellefson).

Common questions

Is PT-141 legal in Canada?

We found no authorized bremelanotide product in Health Canada's Drug Product Database. Unauthorized health products are illegal to sell or promote.

Does PT-141 work for men?

Its US approval is only for premenopausal women with HSDD.

PT-141 vs melanotan II?

Both act on melanocortin receptors. Bremelanotide went through Phase 3 trials and FDA review; melanotan II did not.

Sources

  1. FDA approval package — Vyleesi (bremelanotide), Jun 21, 2019
  2. Kingsberg SA et al. Bremelanotide for HSDD: two randomized phase 3 trials. Obstet Gynecol 2019
  3. Spielmans GI, Ellefson EM. Small effects, questionable outcomes: bremelanotide for HSDD. J Sex Res 2024
  4. Health Canada Drug Product Database (searched Nov 10, 2026)

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