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FDA Approved 19 views

PT-141 (Bremelanotide)

Melanocortin receptor agonist FDA-approved for sexual dysfunction

PT-141 (Bremelanotide) molecular structure

Overview

PT-141 (Bremelanotide), sold as Vyleesi, is the first FDA-approved medication that works through the brain to increase sexual desire. Unlike Viagra-type drugs that improve blood flow, PT-141 activates desire at its source — your central nervous system. **How does it work?** PT-141 activates melanocortin-4 receptors (MC4R) in your hypothalamus, the brain region that controls sexual arousal. It essentially "turns on" the neural pathways responsible for wanting sex, not just the physical ability to have it. **What the research shows:** • FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women • Clinical trials showed significant increases in desire, arousal, and satisfaction • Works within 45 minutes of injection • Effects can last up to 24 hours • Also studied for male erectile dysfunction (though not approved for this) **The discovery story:** PT-141 came from Melanotan II research. Scientists developing a tanning peptide noticed unexpected sexual arousal effects — leading to a whole new drug. **Common side effects:** Nausea (about 40% of users), flushing, and headache. Most side effects are temporary. **Important to know:** Administered as a subcutaneous injection at least 45 minutes before anticipated activity. Limited to 8 doses per month. --- **Sources:** FDA Prescribing Information for Vyleesi (2019) | Kingsberg SA, et al. (2019) Obstetrics & Gynecology | Clayton AH, et al. (2016) Journal of Sexual Medicine

Last reviewed: 2026-08-18

Identity & Aliases

Also known as

PT-141BremelanotideVyleesimelanocortin receptor agonist (α-MSH analog)
CAS189691-06-3
PubChem9941379

Full composition (formula, molecular weight, sequence) in Quick Facts →

Research Areas

Hypoactive sexual desire disorder (HSDD)Female sexual dysfunctionMelanocortin receptor pharmacologySexual arousal and desire

Available Evidence

Human

Bremelanotide is FDA approved (June 2019, brand Vyleesi) for acquired, generalized HSDD in premenopausal women. The phase 3 RECONNECT trials showed significant improvements in sexual desire and reduced distress versus placebo, with common side effects including nausea, flushing, and transient blood pressure increases.

Animal

Animal studies show that melanocortin agonists of the PT-141/melanotan lineage activate central MC3/MC4 receptors to stimulate sexual arousal and erectile responses in rodents.

In Vitro

Binding and functional assays confirm bremelanotide is a potent, nonselective agonist at melanocortin receptors (MC1R, MC3R, MC4R), a cyclic heptapeptide analog of alpha-MSH.

Key Studies & Findings

2 studies
Clinical2019

Two phase 3 trials (RECONNECT) found bremelanotide significantly improved sexual desire and reduced distress versus placebo in premenopausal women with HSDD; effects on some co-primary endpoints (e.g., satisfying sexual events) were mixed.

Clinical2019

The FDA approved Vyleesi (bremelanotide) 1.75 mg subcutaneous autoinjection for acquired, generalized hypoactive sexual desire disorder in premenopausal women.

Benefits & Effects

10 documented

FDA-approved libido enhancement

anecdotal

Sexual desire boost

anecdotal

Central nervous system activation

anecdotal

Effective in premenopausal women

anecdotal

Non-hormonal approach

anecdotal

Clinically proven efficacy

anecdotal

HSDD Treatment: Significant improvement in desire/distress scores

clinical

Significant improvement in sexual desire (FSFI scale)

clinicalsexual function

Decreased distress related to lack of desire

clinicalsexual function

On-demand therapy option for HSDD

clinicalconvenience

Side Effects & Safety

15 reported

Nausea (39.9%, common)

moderatecommon

Facial flushing (20.4%)

mildcommon

Headache (11%)

mildcommon

Blood pressure increase

moderateuncommon

Facial flushing

mild

BP increase

mild

Mild-Moderate side effect

Very common (40%) Reversible

Onset: Within 1 hour

Management: Anti-emetic therapy (13%); improves after first dose

Dose-dependent

Mild-Moderate side effect

Common (20.3%) Reversible

Onset: Hours

Management: Supportive care; self-resolving

Dose-dependent

Mild-Moderate side effect

Common (11.3%) Reversible

Onset: Hours

Management: Standard analgesics

Dose-dependent

Mild side effect

mildCommon (1.9 mmHg mean) Reversible

Onset: 2-4 hours, peaks 4-8h

Management: Monitor BP; CONTRAINDICATED in uncontrolled HTN

Dose-dependent

Moderate side effect

moderateUncommon (1%) at recommended dose; 38% with daily

Onset: Cumulative

Management: Consider discontinuation; ≤8 doses/month

Dose-dependent

Flushing

mildUncommon

Headache

mildUncommon

Rare gum/skin pigmentation

severeRare

Nausea

mildUncommon

Limitations & Open Questions

Approval is limited to premenopausal women with acquired, generalized HSDD; benefits are modest, nausea is frequent, blood pressure elevations warrant warnings in hypertensive or cardiovascular patients, and long-term data are still accumulating. Use in men or as a general 'libido' drug is not approved.

Pharmacology

Bremelanotide is a cyclic heptapeptide melanocortin receptor agonist (MC1R/MC3R/MC4R) administered by subcutaneous injection (Vyleesi 1.75 mg) on demand, with effects on desire typically beginning within about an hour. As a peptide it has limited oral bioavailability.

Reported Research Dosing

Reported values from research literature and community protocols. Educational reference only — not a dosing recommendation or medical advice.

1.75 mg PRN

Route: SC
Half-life: Variable

Research Protocols

Female HSDD (FDA-approved)

Dose
1.75mg
Frequency
As needed, max 1 dose/24hr
Route
Subcutaneous (abdomen/thigh)

Male Erectile Dysfunction

Dose
1-2mg
Frequency
As needed, 45-60min before activity
Route
Subcutaneous

Female Arousal Disorder

Dose
0.75-1.25mg
Frequency
As needed, max 1 dose/24hr
Route
Subcutaneous

Low Starting Dose

Dose
0.5mg
Frequency
Test dose to assess tolerance
Route
Subcutaneous

Research protocols are for educational purposes only. Always consult qualified medical professionals.

Frequently Asked Questions

Is PT-141/bremelanotide FDA approved?

Yes - as Vyleesi (bremelanotide) in 2019 for acquired, generalized hypoactive sexual desire disorder in premenopausal women.

How is it taken?

As a subcutaneous autoinjection on demand (1.75 mg), typically about 45 minutes before anticipated sexual activity.

What are the common side effects?

Nausea, flushing, injection-site reactions, and transient blood pressure increases; it carries warnings for people with uncontrolled hypertension or cardiovascular disease.

Research Citations

4

PT-141 Palatin.

Hedlund P (2004)

5
Medical Treatment of Female Sexual Dysfunction.

Nappi RE, Tiranini L, Martini E, Bosoni D, Righi A, Cucinella L (2022)

+ 36 more citations

Related Resources

Quick Facts

Formula

C50H68N14O10

Molecular Weight

1025.18

Sequence

Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH

Mechanism

Melanocortin receptor agonist

Safety Information

FDA-approved with established safety profile. Common side effects include nausea and flushing.

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