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PT-141Sexual Health

Bremelanotide studied for libido and arousal.

Peptides·Index rating
5/5Established
Human data
Safety
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Quick factsat a glance
Status
Prescription
Developer
Palatin Technologies; marketed as Vyleesi for HSDD
Receptors / target
Melanocortin receptor agonist (alpha-MSH analog); highest affinity at MC1R and MC4R; central MC4R activation modulates sexual desire/arousal pathways
FDA-approved?
YES
Prescription available?
YES
Studied for
sexual dysfunctionlibido / arousalerectile functionfemale HSDD

Overview

PT-141 (bremelanotide) is a synthetic cyclic peptide analog of alpha-melanocyte-stimulating hormone (alpha-MSH) that acts as a melanocortin receptor agonist. It is FDA-approved as Vyleesi (subcutaneous, 2019) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD); it was earlier studied by the intranasal route for erectile dysfunction. Unlike PDE5 inhibitors, it acts centrally rather than on the vasculature. This profile reports what the trials and label observed and is not treatment or dosing guidance.

Mechanism

Bremelanotide non-selectively activates melanocortin receptors, with highest affinity at MC1R and MC4R; central MC4R activation is the pathway believed to modulate sexual desire and arousal. As an alpha-MSH analog it works upstream in hypothalamic and related neural circuits. MC1R activity in the skin underlies its melanocortin-class effect of hyperpigmentation. The mean terminal half-life is approximately 2.7 hours.

Clinical evidence

Human evidence is substantial. The two phase 3 RECONNECT RCTs (Kingsberg et al., Obstet Gynecol 2019) showed that 1.75 mg subcutaneous bremelanotide, taken as needed, significantly improved sexual desire and reduced desire-related distress versus placebo over 24 weeks in premenopausal women with HSDD; a 52-week open-label extension confirmed the profile with no new safety signals. Earlier human work (Int J Impot Res 2004) showed a dose-dependent erectogenic response to intranasal PT-141 in men. The approved indication and pivotal efficacy data are in premenopausal women.

Safety profile

The most common adverse events are nausea (~40%, often improving after the first dose), flushing (~20%) and headache. Bremelanotide causes a transient increase in blood pressure and a small heart-rate reduction (peaking 2-4 h post-dose, resolving within ~12 h), so it is contraindicated in uncontrolled hypertension or known cardiovascular disease per the label. Focal hyperpigmentation can occur — more likely in darker skin and with frequent dosing — and may not resolve after discontinuation. This is YMYL safety information, not treatment advice.

Timelinecommonly reported
  1. Per dose (acute)

    Taken as needed before activity; onset is typically within ~45 minutes to a few hours, and the effect is per-dose rather than cumulative.

  2. Over weeks of use

    In the phase 3 RECONNECT trials, improvements in sexual desire and desire-related distress were measured over 24 weeks of as-needed use. Nausea and flushing are common around dosing.

Reported side effectsreported in literature

Reported in published literature and user reports. Not a complete list, and not medical advice.

  • Nausea
  • Flushing
  • Headache
  • Transient blood-pressure increase
  • Focal hyperpigmentation

If severe or unexpected symptoms occur, contact a qualified medical professional. PEPTIDES·INDEX does not provide medical advice.

Cautionsdiscuss with a clinician
Use caution or avoid if
  • Uncontrolled hypertension (per the Vyleesi label) — bremelanotide transiently raises blood pressure
  • Known cardiovascular disease, given the transient pressor effect
Interactions
  • Orally administered drugsMay slow gastric emptying and reduce or delay the absorption of concomitantly taken oral medications
  • Antihypertensive agentsCaution advised — bremelanotide's transient blood-pressure increase may counteract blood-pressure-lowering therapy

Compare

  • vs Kisspeptin

    Also studied for sexual desire/arousal but acts on the reproductive (KISS1R/GnRH) axis and remains investigational, not approved

  • vs Oxytocin

    Another neuropeptide tied to sexual and social behavior, but its approved use is obstetric; social/arousal use is investigational

FAQ

Is PT-141 (bremelanotide) FDA-approved?

Yes. Bremelanotide is FDA-approved as Vyleesi (2019) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Use outside that indication, and the research-grade injectable sold for other purposes, is not approved.

How is PT-141 different from PDE5 inhibitors like sildenafil?

PT-141 acts centrally as a melanocortin (MC4R) receptor agonist to influence sexual desire and arousal pathways, whereas PDE5 inhibitors act on vascular blood flow. They work through entirely different mechanisms.

Why can PT-141 raise blood pressure?

Melanocortin agonism causes a transient rise in blood pressure and small drop in heart rate, peaking roughly 2-4 hours post-dose and resolving within about 12 hours. For this reason the label contraindicates it in uncontrolled hypertension or known cardiovascular disease.

How is PT-141 administered?

The approved Vyleesi product is a single-use subcutaneous autoinjector given in the abdomen or thigh, as needed at least 45 minutes before anticipated activity, with a label maximum of one dose per 24 hours and eight per month. Earlier research used an intranasal formulation, but the approved route is subcutaneous.

Is PT-141 the same as Melanotan II?

No. Both are cyclic melanocortin-receptor agonists derived from alpha-MSH and the structures are closely related, but PT-141 (bremelanotide) is the FDA-approved Vyleesi for HSDD, whereas Melanotan II is an unlicensed tanning product with documented harms. They should not be conflated.

What are the most common side effects of PT-141?

In the phase 3 trials the most frequent adverse events were nausea (around 40 percent, often easing after the first dose), flushing (around 20 percent) and headache. Focal hyperpigmentation can also occur, more often with darker skin and frequent dosing, and may persist after stopping.

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Sources

Starting references for the library summary. These are not dosing instructions or medical advice.

For research-use educational context only. Not medical advice and not a recommendation to use any compound. Consult a qualified healthcare professional before any health decision.