Bremelanotide

What Bremelanotide does

Vyleesi contains bremelanotide, approved for distressing low desire across situations and partners in women before menopause who previously had normal desire. Two large placebo-controlled trials found modest desire and distress improvements, with no clear increase in satisfying sexual events. Nausea and temporary blood pressure rises are the main concerns. Online PT-141 powders and sprays are different products.

• Vyleesi is approved for distressing low sexual desire in women before menopause, when other illnesses, medicines or relationship problems don't explain it. (Drug label)
• In two large trials, women had modest gains in desire and less distress, though the number of satisfying sexual events did not rise. (Studied in a trial)
• One man reported stronger libido and erections; others report a better sexual response when pairing it with tadalafil. (Reported by users)

Uses in the sources

• Vyleesi is FDA-approved for acquired, generalized HSDD in premenopausal women when other illnesses, medicines and relationship problems do not explain it. (Drug label) (source)
• Early trials studied erections and female arousal. A later male nasal trial has an expression of concern. These uses are outside US approval. (Studied in a trial) (source)
• Short inpatient trials studied appetite and weight. A tirzepatide combination trial has no posted results; no weight-loss indication is approved. (Studied in a trial) (source)

Bremelanotide dosage

Typical reported dose: 1.75 mg as needed, at most once in 24 hours

• Vyleesi: 1.75 mg as needed: Inject 1.75 mg subcutaneously via the autoinjector to the abdomen or thigh. as needed; no more than one dose within 24 hours, under the skin. Drug label. Studied in: Premenopausal women with acquired, generalized HSDD. (source)
• Dose finding: 0.75 mg: 0.75 mg as needed; no more than once daily or 16 doses per 4 weeks, under the skin. Studied in a trial. Studied in: Premenopausal women with desire and/or arousal problems. (source)
• Dose finding: 1.25 mg: 1.25 mg as needed; no more than once daily or 16 doses per 4 weeks, under the skin. Studied in a trial. Studied in: Premenopausal women with desire and/or arousal problems. (source)
• Dose finding: 1.75 mg: 1.75 mg as needed; no more than once daily or 16 doses per 4 weeks, under the skin. Studied in a trial. Studied in: Premenopausal women with desire and/or arousal problems. (source)
• RECONNECT: fixed 1.75 mg: 1.75 mg as needed; at least 24 hours apart, under the skin. Studied in a trial. Studied in: Premenopausal women with acquired, generalized HSDD. (source)
• Early injection: 4 mg: 4 mg single study-visit dose, under the skin. Studied in a trial. Studied in: Men with poor sildenafil response. (source)

Highest studied: Single monitored SC dose, not a repeated-dose safety limit..

These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.

Work out syringe units with the dosing calculator

How to store Bremelanotide

Comes as: Vyleesi single-dose prefilled autoinjector, 1.75 mg/0.3 mL.

Mixed with: None. The approved pen is not reconstituted..

• Inspect before use. Discard cloudy, discolored or visibly particulate solution.

Before mixing: Store at or below 25°C. Do not freeze. Protect from light.

After mixing: Ready-made single-dose solution; discard the device after use.

Vyleesi single-dose autoinjectors: store at or below 25 C, protected from light; do not freeze. The solution needs no mixing; discard the autoinjector after one use.

Bremelanotide side effects and risks

Reported side effects

• Nausea: 40.0% vs 1.3% placebo; 8% stopped because of nausea., moderate (source)
• Flushing: 20.3% vs 0.3% placebo., mild (source)
• Injection-site reactions: 13.2% vs 8.4% placebo., mild (source)
• Headache: 11.3% vs 1.9% placebo., moderate (source)
• Vomiting: 4.8% vs 0.2% placebo., moderate (source)
• Fatigue: 3.2% vs 0.5% placebo., moderate (source)
• Dizziness: 2.2% vs 0.5% placebo., moderate (source)
• Temporary blood pressure rise: Maximum mean rises 6/3 mmHg; heart rate fell up to 5 beats/min. Usually resolves within 12 hours., serious (source)
• Persistent dark patches: About 1% vs 0% placebo with up to 8 monthly doses. Daily dosing caused much higher rates., moderate (source)
• Acute liver inflammation: One extension case after 10 doses in a year; causality uncertain., serious (source)

Stop and get help if

• Chest pain, fainting, severe headache or new weakness.: Stop dosing and seek emergency care.
• Severe or persistent vomiting, or inability to keep fluids down.: Stop dosing and get prompt medical assessment.
• Yellow eyes, dark urine or severe upper abdominal pain.: Seek urgent assessment for liver injury.
• A new or changing mole, uneven color, bleeding or a fast-growing spot.: Pause use and arrange prompt skin assessment.
• An erection lasting 3–4 hours after off-label use in a man.: Seek emergency care; do not repeat the dose.

Who should avoid it

• uncontrolledBloodPressure: Formal Vyleesi contraindication; each dose can raise blood pressure.
• heartCondition: Known cardiovascular disease is a formal contraindication.
• pregnant: Animal studies found fetal harm. Stop if pregnancy is suspected.
• tryingToConceive: Use effective contraception; pregnancy exposure is insufficiently studied.
• breastfeeding: Infant safety is unknown. A completed milk-PK registration has no posted results.
• under18: Pediatric safety and effectiveness have not been established.
• melanomaOrAtypicalMoles: Precaution for melanocortins. This is not a formal Vyleesi label contraindication.
• kidneyDisease: Severe impairment increases exposure and may worsen nausea or vomiting.
• liverDisease: Severe impairment was not studied; moderate impairment increases exposure.
• other: Higher cardiovascular risk needs review even without diagnosed cardiovascular disease.

Interactions

• Oral naltrexone: Can greatly reduce naltrexone exposure. Avoid with oral products used for alcohol or opioid addiction.
• Oral drugs needing reliable absorption: Slower stomach emptying can reduce or delay drug uptake. The label advises avoiding use with threshold-dependent oral drugs.
• Other melanocortin agonists: Duplicate receptor activity may add pigment or systemic effects. This combination has no established dosing safety.
• Sildenafil or tadalafil: A small nasal sildenafil study exists. It does not establish safety of injected PT-141 with tadalafil.
• Ondansetron pretreatment: 8 mg orally 30 minutes before Vyleesi did not prevent nausea and is not recommended for that purpose.
• Alcohol: A small nasal study found no major interaction at 0.6 g/kg. This does not cover heavy drinking or all health conditions.

Product quality risks

• Forensic LC-HRMS identified bremelanotide in seized black-market samples; this did not establish safe strength, sterility or stability.
• Compounded medicines are not FDA-approved. Contamination and incorrect strength can cause serious harm.

What to expect

• Around the first dose: Nausea is common with Vyleesi, usually starting within about an hour and lasting about two hours.
• Within 12 hours after a dose: Vyleesi can briefly raise blood pressure and slow the pulse, with readings usually returning to baseline within 12 hours.
• Later doses: Nausea is most common after the first Vyleesi dose and is less common with later doses.
• Week 8: The Vyleesi label calls for stopping treatment if symptoms have not improved after eight weeks.

Vyleesi is used as needed for eligible premenopausal women with low sexual desire, at most once per 24 hours; more than eight monthly doses is not recommended.

A 2022 safety review counted 43 completed studies and 3,500 participants, a minimum, not a complete 2026 count.

Key studies

• Dose finding: 0.75–1.75 mg: The 1.75 mg dose advanced to phase 3. (source)
• RECONNECT 301: 1.75 mg: Desire and distress improved modestly; satisfying event counts did not. (source)
• RECONNECT 302: 1.75 mg: Desire and distress improved modestly; satisfying event counts did not. (source)
• RECONNECT: one-year extension: The extension adds longer exposure but has strong survivor bias. (source)
• Early male injection studies: Single doses up to 10 mg were studied; that is not a safe repeated-dose ceiling. (source)
• Early male nasal studies: Responses were significant at doses above 7 mg; first erection began at about 30 minutes. (source)

Bremelanotide FAQ

• Is Bremelanotide FDA-approved? Yes: Vyleesi (acquired, generalized HSDD in premenopausal women.). Not approved for men, postmenopausal women, sexual performance or weight loss. No separate 503B bulks-list entitlement was confirmed.
• How do people take it? Under the skin, as needed; no more than one dose within 24 hours. Stop after 8 weeks if symptoms have not improved.. Source: drug label.
• What's the difference between Bremelanotide and Melanotan II? Bremelanotide: an as-needed injection for low libido before menopause; nausea is common. Melanotan II: an unapproved tanning peptide with small human trials and reports of serious harm. Why people pair them: some users report concurrent libido and tanning use.
• Can I take it with Melanotan II? Some users report concurrent libido and tanning use. Overlapping melanocortin effects; no controlled safety evidence for the combination. Source: reported by users. Ask a doctor before combining anything.
• Is it banned in sport? No, it is not on the banned list (WADA 2026). Inferred from the 2026 list and human drug approval: no named ban found, and S0 does not apply to an approved substance. Verify the exact product.
• How do I store it once opened? Ready-made single-dose solution; discard the device after use.