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PT-141 (Bremelanotide)

Aliases: Bremelanotide · Vyleesi · Rekynda

Last verified: 2026-09-23

Approved drugLimited evidencePeptidesMedium interest

The short version

PT-141 (bremelanotide) is proof that a melanocortin peptide can become a real drug: FDA-approved in 2019 for premenopausal female sexual dysfunction after the phase III RECONNECT trials. The effect is moderate (mean difference vs placebo is modest), and the profile includes nausea, flushing and — importantly — blood pressure increases, so the approval is restricted. This is how a 'libido peptide' behaves in real medicine: modest, measurable benefit and real risks.

Identity & type

Molecular type
analog
Sequence / structure
Ciklični heptapeptid (bremelanotid)
Molecular weight
~1025 Da
Origin
Melanocortin agonist developed from the same chemistry as Melanotan-2; FDA-approved for female sexual dysfunction (Vyleesi).

Mechanism of action

MC4R (and partial MC1R) agonist in the hypothalamus → enhances sexual desire via central pathways.

not confirmed in humans

Dosing & routes

Official / clinical context

Approved drug — indications, dosing and warnings are defined by the official label. Approved: 1.75 mg SC ≥45 min before activity; max 1 dose/24h, 8 doses/month. Off-label in men 1–2 mg.

Regulator-approved labeling and published study designs — never a recommendation.

Community-reported practice

Approved: 1.75 mg SC ≥45 min before activity; max 1 dose/24h, 8 doses/month. Off-label in men 1–2 mg. Approved (Vyleesi): in women with HSDD, increased desire and satisfying sexual events; the community (including men) reports a strong effect with nausea on the first dose in ~40% of users.

Unverified self-reports. Not medical advice. Not endorsement.

Expected effects (community)

Approved (Vyleesi): in women with HSDD, increased desire and satisfying sexual events; the community (including men) reports a strong effect with nausea on the first dose in ~40% of users.

Protocol — official vs community

Official / label

Vyleesi (approved for HSDD in premenopausal women): 1.75 mg SC at least 45 min before anticipated sexual activity, max one dose per 24 h, max 8 doses/month.

  1. 01No titration — single fixed dose

Duration: On-demand, not continuous.

The only approved melanocortin peptide — and its label is the strictest dosing rule in the class.

Community (anecdotal)

0.5–2 mg SC on-demand (often 1–1.75 mg), or nasal spray forms of unverified bioequivalence.

Cycle:
On-demand.
Break:
Community practice often ignores the 8-dose/month label cap.

Flushing, nausea and transient BP changes are the price; exceeding label frequency has no safety data behind it.

Human evidence

Robust for the approved indication: two phase III RCTs with pre-defined co-primary endpoints.

Preclinical evidence

The preclinical phase was completed and submitted to regulators as part of registration; pharmacology and toxicology details are part of the official label.

Known risks

  • Nausea (~40% in trials), flushing, headachecharacterized
  • Transient blood pressure increase — contraindicated in uncontrolled hypertension and heart diseasecharacterized
  • Skin hyperpigmentation with chronic usecharacterized

Teal: characterized in clinical/labeling contexts. Amber: theoretical or reported outside controlled settings.

Unknowns & evidence gaps

  • Efficacy in men (trials did not lead to approval)

Frequently asked questions

References

  1. Kingsberg S.A. et al., RECONNECT phase III trials of bremelanotide (Obstet Gynecol, 2019)
  2. Vyleesi (bremelanotide) — FDA label