ION BLUE Encyclopedia

PT-141

PT-141 (bremelanotide) is a melanocortin-receptor agonist peptide, FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women.

Evidence: High

Reading time:2 min
Citations:3
Updated:July 11, 2026

Type

Peptide

INCI Name

Cyclic heptapeptide melanocortin receptor agonist (bremelanotide)

Direct Answer

PT-141 (bremelanotide) is a melanocortin-receptor agonist peptide, FDA-approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women.

Summary Table

Evidence Level

High

AI Summary

PT-141 (bremelanotide) is a cyclic heptapeptide melanocortin receptor agonist. Evidence is high for its approved use: it was approved by the FDA in 2019 (as Vyleesi) for acquired, generalized hypoactive sexual desire disorder in premenopausal women, supported by randomized phase 3 trials (the RECONNECT program) and an earlier dose-finding randomized trial. The most commonly reported adverse events are nausea, flushing, headache, and injection-site reactions; transient blood-pressure increases and focal hyperpigmentation have also been reported. Material sold as unregulated "PT-141" is not the approved product.

Key Information

Classification

Emerging Research1 Mechanisms

Key Takeaways

  • PT-141 (bremelanotide) is an FDA-approved melanocortin-agonist peptide (Vyleesi, 2019) for HSDD in premenopausal women
  • Approval is supported by randomized phase 3 trials; average benefit is modest
  • Common side effects include nausea, flushing, and headache; blood-pressure effects limit some use

Scientific Overview

In Plain English

PT-141, known as bremelanotide (brand name Vyleesi), is an approved prescription medicine that acts on melanocortin receptors. It is approved in the US for a specific type of low sexual desire in premenopausal women and is given by injection under medical guidance. Common side effects include nausea, flushing, and headache. Unregulated "PT-141" sold online is not the approved medicine.

Scientific Details

Bremelanotide (PT-141) is a synthetic cyclic heptapeptide agonist at melanocortin receptors (notably MC4R). It received FDA approval in 2019 for acquired, generalized HSDD in premenopausal women based on two randomized, placebo-controlled phase 3 trials (RECONNECT) and supporting dose-finding data. Reported adverse events include nausea, flushing, headache, injection-site reactions, transient increases in blood pressure and reductions in heart rate, and focal hyperpigmentation with repeated dosing.

How It Works

Bremelanotide is described as an agonist at melanocortin receptors, including MC4R in the central nervous system, a pathway associated with sexual-response signaling. This mechanism is characterized in pharmacology studies and supported by randomized clinical trials for the approved indication.

Mechanism of Action

Melanocortin receptor agonism

human

Bremelanotide activates melanocortin receptors (including MC4R), a central pathway associated with sexual-response signaling.

Evidence Level

Human Evidence

Two randomized, placebo-controlled phase 3 trials (RECONNECT) and an earlier dose-finding randomized trial support the approved HSDD indication; a safety analysis across the clinical development program characterizes adverse events.

Animal Evidence

Preclinical work characterized melanocortin-receptor pharmacology and effects on sexual behavior.

Limitations

Approved efficacy is specific to acquired, generalized HSDD in premenopausal women; benefit is modest on average and not established for other populations or uses. Blood-pressure effects limit use in some patients.

Why This Grade

Graded high for the approved indication: supported by randomized, placebo-controlled phase 3 trials and FDA approval. This grade applies to the regulated product and indication, not to off-label or unregulated use.

Frequently Asked Questions

What are the side effects of PT-141 (bremelanotide)?

PT-141 (bremelanotide) is a prescription medicine given by injection under medical supervision — not a cosmetic. Its most common side effect is nausea, which was a frequent reason for stopping in trials; flushing, headache, and injection-site reactions are also common. It can cause transient increases in blood pressure and decreases in heart rate, so it is not recommended in people with uncontrolled hypertension or cardiovascular disease. Focal hyperpigmentation (including of the face, gums, and breasts) has been reported, more with repeated dosing.

Is PT-141 FDA-approved?

Yes. PT-141 was approved by the FDA in 2019 as bremelanotide (brand name Vyleesi) for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, given by subcutaneous injection under medical supervision. Approval was based on two randomized, placebo-controlled phase 3 trials (the RECONNECT program); the average benefit is modest, and approval is specific to that indication and population.

How does PT-141 work?

PT-141 (bremelanotide) is a melanocortin-receptor agonist. It activates melanocortin receptors — including MC4R in the central nervous system — a pathway associated with sexual-response signaling. This mechanism is characterized in pharmacology studies and supported by randomized clinical trials for the approved indication.

Is the 'PT-141' sold by research-chemical vendors the same as Vyleesi?

No. The approved medicine is bremelanotide (Vyleesi), a regulated prescription product. Material sold as 'PT-141' by research-chemical vendors outside that approved product is not quality-controlled and is not the regulated medicine.

How strong is the evidence for PT-141, and who ran the studies?

The evidence is graded high for its approved use: it is supported by randomized, placebo-controlled phase 3 trials and FDA approval. However, the benefit is modest on average and is established only for acquired, generalized HSDD in premenopausal women — not for other populations or uses. It is worth noting that the pivotal trials were manufacturer-sponsored (Palatin Technologies and AMAG Pharmaceuticals, the developer/marketer of bremelanotide).

What's the difference between Melanotan II and PT-141 (bremelanotide)?

Both are melanocortin-receptor agonists, but they differ sharply in regulatory status and safety. Melanotan II is an unlicensed research chemical that is not approved for human use; most of its evidence is from animal studies, human data are limited, and unregulated use has been associated with changes in moles/pigmented skin lesions (including a case report of melanoma). PT-141 (bremelanotide) is a separate, FDA-approved melanocortin-agonist prescription medicine (Vyleesi), covered in its own entry. This is a comparison of what each one is and its approval status — not a claim that either is more effective than the other.

References

  1. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics and Gynecology. (Manufacturer study — sponsor/authors Palatin Technologies, Inc. and AMAG Pharmaceuticals, Inc. (developer/marketer of bremelanotide).)Two Phase 3 HSDD RCTs; manufacturer-sponsored.Human Studydoi:10.1097/AOG.0000000000003500
  2. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women's Health (London). (Manufacturer study — authored by Palatin Technologies, Inc. employees (developer of bremelanotide).)Phase 2 dose-finding RCT in premenopausal women; manufacturer-sponsored.Human Studydoi:10.2217/whe-2016-0018
  3. Safety Profile of Bremelanotide Across the Clinical Development Program. Journal of Women's Health. (Manufacturer study — sponsor/authors Palatin Technologies, Inc. and AMAG Pharmaceuticals, Inc. (developer/marketer of bremelanotide).)Pooled safety analysis across the clinical program; manufacturer-authored.Human Studydoi:10.1089/jwh.2021.0191

Alternative Names

  • Bremelanotide
  • Vyleesi
  • PT141

Risks & Safety

  • Nausea is common and was a frequent reason for discontinuation in trials
  • Flushing, headache, and injection-site reactions are commonly reported
  • Transient increases in blood pressure and decreases in heart rate occur; it is not recommended in uncontrolled hypertension or cardiovascular disease
  • Focal hyperpigmentation (including of the face, gums, and breasts) has been reported, more with repeated dosing
  • Material sold as unregulated "PT-141" is not quality-controlled and is not the approved medicine

Claim Boundaries

ION BLUE is an educational research aggregator. This content summarizes published scientific literature. It is not medically reviewed, is not medical advice, and is not a recommendation to use any substance. Some peptides discussed are approved medicines; others are research chemicals not approved for human use. Consult a licensed healthcare provider. Bremelanotide is a prescription medicine; this educational summary is not medical advice and not a recommendation to start, stop, or change any treatment, nor to use unregulated "PT-141".

This page summarizes published research and is for informational purposes only; it is not medical advice.