Sexual Health FDA-Approved (limited indication) / Active Research

PT-141 (Bremelanotide)

PT-141, also known as Bremelanotide, is a melanocortin receptor agonist originally developed from Melanotan II. It is FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women and studied for male sexual dysfunction.

Reviewed by Dr. Sarah Kimura, PharmD, BCPS | Last reviewed:

FDA Status
FDA-approved as Vyleesi (bremelanotide) for hypoactive sexual desire disorder (HSDD) in premenopausal women
Research Status
FDA-Approved (limited indication) / Active Research
Common Uses
  • • Hypoactive sexual desire disorder (HSDD) in women
  • • Male erectile dysfunction (research use)
  • • Sexual arousal and libido enhancement

Medical Disclaimer: This monograph is for educational purposes only. It does not constitute medical advice. PT-141 (Bremelanotide) has not been evaluated or approved by the FDA for human use unless noted. Consult a licensed healthcare provider before using any peptide.

What is PT-141?

PT-141 (generic name: bremelanotide) is a synthetic peptide analogue of alpha-melanocyte stimulating hormone (α-MSH). Unlike traditional sexual dysfunction treatments that work peripherally (e.g., PDE5 inhibitors like sildenafil), PT-141 acts centrally — directly stimulating melanocortin receptors in the brain that are involved in sexual arousal.

The compound was originally derived from Melanotan II, another melanocortin peptide, when researchers observed unexpected sexual arousal as a side effect in early clinical testing.

How PT-141 Works

PT-141 is a melanocortin receptor agonist, primarily activating:

  • MC3R and MC4R receptors in the central nervous system (hypothalamus and limbic regions)
  • These receptors are involved in regulating sexual arousal, appetite, and energy homeostasis
  • Unlike PDE5 inhibitors, it does not require sexual stimulation to work — it increases the intrinsic desire for sexual activity

FDA Approval & Indications

Vyleesi (bremelanotide) received FDA approval in June 2019 for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. It is administered as a subcutaneous injection into the abdomen or thigh at least 45 minutes before anticipated sexual activity.

HSDD is characterized by persistent low sexual desire that causes personal distress.

Research in Men

While not FDA-approved for men, PT-141 has been studied for:

  • Erectile dysfunction, including in men who don’t respond to PDE5 inhibitors
  • Enhancement of sexual arousal in healthy male volunteers

Results have been promising but no regulatory approval exists for these indications.

Side Effects

  • Nausea (most common, often transient)
  • Flushing (face, neck, chest)
  • Transient blood pressure increase — blood pressure typically rises 6–12 mmHg and returns to baseline within 12 hours
  • Headache
  • Injection site bruising

Important Cautions

  • Cardiovascular risk: The transient blood pressure elevation makes PT-141 contraindicated in patients with cardiovascular or cerebrovascular disease, or those taking antihypertensives
  • Not for daily use
  • Not to be used more than once per 24-hour period
  • No more than 1 dose per 8 episodes per month (per FDA labeling)

Medical Disclaimer: PT-141/bremelanotide is a prescription medication. Off-label use should only occur under medical supervision. This content is for educational purposes only.

Safety Profile Summary

FDA-approved safety profile for women with HSDD. Common side effects include nausea, flushing, and temporary blood pressure changes. Contraindicated in patients with cardiovascular disease.

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