Library / Peptides / Sexual Health / PT-141 / Bremelanotide

Strong evidence · Grade A

PT-141 / Bremelanotide

PT-141 (Bremelanotide)

Score

82 / 100

Class

Sexual Health

Brand

Vyleesi

FDA

2019

TL;DR

Part 01 · How it works

Mechanism.

Bremelanotide (brand name Vyleesi) is a melanocortin receptor agonist FDA-approved in June 2019 for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Originally developed from Melanotan II, it was refined to be more selective for MC4R. It is the first and only FDA-approved on-demand treatment for low sexual desire in women, administered as a subcutaneous auto-injection at least 45 minutes before anticipated sexual activity.

Most sexual desire medications work on the body's plumbing (blood flow) or hormones. Bremelanotide is different -- it works on the brain's desire circuitry directly. Think of it as turning up the volume on the brain's interest signal rather than just improving the physical response.

Mechanism · technical

Bremelanotide activates melanocortin 4 receptors (MC4R) in the central nervous system, particularly in the hypothalamus. Unlike hormonal treatments, it works through the dopaminergic reward pathway rather than by modifying hormone levels. MC4R activation in the medial preoptic area and ventromedial hypothalamus increases dopamine release and reduces serotonin-mediated inhibition of sexual response, enhancing sexual desire through central nervous system mechanisms.

Part 02 · Dosing & administration

How it's taken.

Values below describe how PT-141 / Bremelanotide has been administered in published trials and labeling. Provided for educational purposes only — this is not medical advice and not instructions for self-administration. Consult your healthcare provider before making any health decision.

Standard dose

1.75 mg

Subcutaneous injection · As needed, at least 45 minutes before sexual activity

Duration

As needed; no more than once every 24 hours; max 8 doses/month per FDA labeling

FDA-approved (Vyleesi) for premenopausal women with HSDD. Used off-label in men for erectile dysfunction. Melanocortin 4 receptor agonist. Common side effects: nausea, flushing, headache.

Need help with reconstitution?

Use the free peptide calculator for dilution, unit conversion, and injection volume.

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Part 03 · Safety

Side effects, rare serious events, who shouldn't.

Reported side effects

The most common side effects are nausea (40% of patients, most common reason for discontinuation), flushing, injection site reactions, and headache. Transient increases in blood pressure have been observed, so it is not recommended for patients with uncontrolled hypertension or cardiovascular disease. Skin hyperpigmentation (darkening) has been reported with repeated use, particularly in facial areas and gums. Use is limited to no more than 8 doses per month.

Absolute · do not use

Uncontrolled hypertension

History of melanoma or atypical mole syndrome

Cardiovascular disease (myocardial infarction, stroke within past 6 months)

Pregnancy or breastfeeding

Known hypersensitivity to bremelanotide or any component

Concurrent use with other melanocortin receptor agonists

Interactions

Antihypertensives

Bremelanotide causes transient blood pressure increase; may oppose antihypertensive therapy. Per FDA label, use with caution in patients with cardiovascular disease

Moderate

PDE5 inhibitors (sildenafil, tadalafil)

Additive effects on sexual function; risk of hypotension due to opposing vascular effects. FDA labeling recommends against concurrent use with PDE5 inhibitors

Major

Naltrexone

Per FDA label, bremelanotide may reduce the systemic exposure of oral naltrexone; avoid concurrent use

Major

Other melanocortin agonists (Melanotan II)

Additive melanocortin receptor activation; increased risk of nausea, flushing, and hypertension

Moderate

Labs to monitor

Blood Pressure

Before and after each dose initially

PT-141 can cause transient hypertension

CMP (Comprehensive Metabolic Panel)

Baseline and every 6 months

Liver and kidney function

Dermatological Exam

Baseline and annually

Melanocortin agonist — monitor for skin changes

CBC with Differential

Baseline and every 6 months

General safety monitoring

Part 04 · Evidence

How strong is the evidence?

Scores derived from rating, indexed studies, regulatory status, and catalogued safety data for this peptide. Curated per-peptide scoring replaces this when available.

Grade B

Grade B. Evidence is strongest where indications match regulatory approval — pair with a clinician when applying beyond label.

Clinical efficacy

Rating reflects consistent peer-reviewed evidence in its indication.

Study quality

2 indexed studies in our dataset. Designs vary — see Research log for per-study grades.

Regulatory clarity

FDA-approved for at least one indication.

Safety profile

Based on 6 documented contraindications, 4 interactions, 4 lab checkpoints.

Long-term data

Years of post-approval surveillance available.

Part 05 · Research log

Every study we cite.

Each study with its published finding and a plain-language note on limitations or funding.

2019

Bremelanotide for HSDD: RECONNECT phase 3 trials

Bremelanotide significantly improved desire and distress scores in premenopausal women with HSDD

Pivotal Phase 3 RCTs; industry-sponsored (Palatin/AMAG)

PMID 31380607 ↗

2008

Bremelanotide for erectile dysfunction

PT-141 induced erections in men with ED, including those who failed sildenafil

Phase II; small; blood pressure elevations noted

PMID 18321350 ↗

Part 06 · Cost & access

Where you can get it.

Regulatory status

FDA-approved (June 2019) as Vyleesi for HSDD in premenopausal women. Available by prescription as a 1.75 mg subcutaneous auto-injector. Also available through compounding pharmacies at various doses for off-label use. Bremelanotide is a prescription medication, not a controlled substance.

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Part 07 · Your appointment

Questions to bring.

Am I a candidate for bremelanotide based on the FDA-approved indication?

How does bremelanotide compare to flibanserin for HSDD?

What are the blood pressure monitoring requirements?

How often can bremelanotide be safely used per month?