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Sexual Wellness & Libido

PT-141

Vyleesi (FDA-approved brand)

A melanocortin-receptor agonist. FDA-approved (as Vyleesi) only for acquired, generalized hypoactive sexual desire disorder (HSDD) in certain premenopausal women. Any other use is off-label.

Provider Determines Testing FDA-Approved (Different Indication) Subcutaneous injection (as prescribed) Prescription Consultation Required
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What Is It?

PT-141 (bremelanotide) is a synthetic peptide that acts on melanocortin receptors involved in central nervous system pathways related to sexual response. The FDA-approved product Vyleesi is specifically indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in certain premenopausal women. It is not FDA-approved for male sexual dysfunction, erectile dysfunction, or use in postmenopausal women. Any other use represents an off-label decision that requires provider review, including cardiovascular and blood-pressure evaluation.

What May It Support?

  • Sexual response in the FDA-approved patient population
  • Sexual wellness (being evaluated in off-label settings under provider review)

Which Programs May Include It?

Where It Fits

Activates melanocortin receptors (particularly MC4R) in the central nervous system, pathways associated with sexual response.

Beginner
Provider-directed use
Intermediate
Provider-directed use
Advanced
Provider-directed use

Do I Need Bloodwork?

Provider Determines Testing

Blood-pressure monitoring is important because PT-141 can transiently raise blood pressure and reduce heart rate. Follow-up is determined by the treating provider.

Likely baseline panel may include: Provider-determined; cardiovascular and blood-pressure evaluation typically required

Important Safety Information

Common side effects may include:

  • Nausea (common, especially initially)
  • Flushing
  • Headache
  • Injection-site reactions
  • Vomiting
  • Cough
  • Fatigue
  • Transient darkening of skin, gums, or moles (focal hyperpigmentation)
Serious WarningsCan transiently increase blood pressure and reduce heart rate; not recommended for patients with uncontrolled hypertension or known cardiovascular disease without provider clearance
Focal hyperpigmentation of skin, face, or gums has been reported and may not fully resolve after discontinuation
Should not be used more than eight doses per month per the FDA-approved product label

Drug interactions: May reduce absorption of oral naltrexone and other medications; may interact with medications affecting blood pressure or heart rate. Provider should review the complete medication list.

Contraindications:

  • Uncontrolled hypertension
  • Known cardiovascular disease (case-by-case with provider clearance)
  • Pregnancy
  • Known hypersensitivity to bremelanotide
Pregnancy & BreastfeedingNot recommended during pregnancy or while trying to conceive. Discuss reproductive plans with your provider before starting.
Cancer-Related ConsiderationsAny personal or family history of cancer should be disclosed to your provider.

Regulatory Status

The FDA-approved bremelanotide product (Vyleesi) is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is not FDA-approved for male sexual dysfunction, erectile dysfunction, or use in postmenopausal women.

Compounded MedicationIf a compounded bremelanotide product is prescribed, please note that compounded medications are not FDA-approved and are not reviewed by FDA for safety, effectiveness, or quality before marketing.

Frequently Asked Questions

Is PT-141 FDA-approved for men?
No. The FDA-approved bremelanotide product is indicated only for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Any use in men is off-label and requires careful provider review.
Is PT-141 the same as sildenafil or tadalafil?
No. PT-141 acts on central nervous system melanocortin receptors, while sildenafil and tadalafil act on peripheral vascular pathways. They are not interchangeable.
Do I need bloodwork before starting?
Testing requirements are determined by the provider based on your history. A cardiovascular and blood-pressure evaluation is typically required.
How often can I use it?
The FDA-approved product label limits use to no more than eight doses per month. Your provider will determine appropriate use based on your medical history and response.

Consultation

Treatment is not automatically provided. A licensed medical provider must review your history, symptoms, medications, laboratory results, and treatment goals before determining eligibility.

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Not Medical Advice

The information provided on this website is for general educational purposes and is not medical advice, a diagnosis, or a prescription. Treatment recommendations are not final until a licensed medical provider completes a live consultation, reviews your medical history and medications, evaluates relevant laboratory results, and determines that treatment is medically appropriate.

Compounded Medication Disclosure

Certain treatments may be prepared by a compounding pharmacy pursuant to an individual prescription. Compounded medications are not FDA-approved, and FDA does not review them for safety, effectiveness, or quality before marketing.

Results

Your results identify subjects to discuss with a provider. They do not establish medical eligibility or guarantee that any medication will be prescribed.

Emergencies

This website is not intended for emergencies. Call 911 or seek immediate medical attention for urgent or severe symptoms.