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Sexual healthApproved (US)

PT-141

Bremelanotide · Vyleesi

Bremelanotide activates MC3R and MC4R melanocortin receptors within the brain. It engages dopamine-mediated reward signaling and hypothalamic circuits involved in sexual behavior. The resulting effects on desire are mediated centrally and do not depend on changes in vascular blood flow.

Not medical advice. Educational reference only.

Route
Subcutaneous autoinjector
Storage
Keep refrigerated at 2–8°C and use within 28 days.

What is PT-141?

PT-141, also called bremelanotide, is marketed by prescription as Vyleesi. FDA approval covers hypoactive sexual desire disorder, or HSDD, in women before menopause. Its action on brain melanocortin receptors increases sexual desire and arousal through central signaling. PDE5 inhibitors instead act on peripheral blood flow. The approved presentation is a subcutaneous autoinjector used 45 minutes before anticipated sexual activity. Preparation by 503A compounding pharmacies is prohibited.

Mechanism of action

Bremelanotide activates MC3R and MC4R melanocortin receptors within the brain. It engages dopamine-mediated reward signaling and hypothalamic circuits involved in sexual behavior. The resulting effects on desire are mediated centrally and do not depend on changes in vascular blood flow.

Targets: Melanocortin MC3R · Melanocortin MC4R

Research indications

  • Sexual Function

    Effective

    Clinical and experimental findings support effects on the sexual response.

  • Libido Support

    Effective

    Clinical findings include improvements in measures of arousal and sexual desire.

  • Melanocortin Activity

    Moderate

    Central melanocortin receptor signaling contributes to the compound’s effects.

Interactions

  • PDE5 Inhibitors (Sildenafil, Tadalafil)

    Monitor

  • Blood Pressure Medications

    Caution

  • Other Melanocortin Agonists

    Avoid

  • Naltrexone

    Monitor

How to reconstitute and inject

Diluent: Use bacteriostatic water; avoid saline because it may cause precipitation.

  1. Let your refrigerated PT-141 vial warm to room temperature for 15–20 minutes before preparation.
  2. Disinfect the vial’s rubber closure with an alcohol wipe, then wait until it has dried completely.
  3. Use a sterile syringe to measure the calculated amount of bacteriostatic water. Avoid saline because precipitation may occur.
  4. Add the water slowly against the vial’s inner wall. Keep the stream away from the dry powder itself.
  5. Rotate the vial gently to mix its contents. Do not shake forcefully, because this can damage the peptide.
  6. Wait 2–3 minutes for the powder to dissolve completely. Check that the liquid is transparent and has no color.
  7. Measure your calculated subcutaneous dose with an insulin syringe after dissolution.
  8. Choose the abdomen, upper arm or thigh for injection. Alternate the injection location each time to help prevent lipodystrophy.
  9. Refrigerate the mixed solution at 2–8°C, and discard any remainder after 28 days. Use these steps only for an appropriate research formulation; follow the specific product instructions for prescription presentations.

What to expect

Week 1–2
An early adjustment period may accompany initial effects. Watch for adverse reactions while assessing tolerance.
Week 2–4
The main effects may begin to emerge. Change the dose only in accordance with your clinician’s recommendations.
Week 4–8
The intended effects may become established during this interval. Review your progress together with your clinician.
Week 8+
Reassess the outcome and discuss whether to continue, introduce a cycle break or change the dose. These research expectations do not establish individual treatment outcomes.

Side effects and safety

  • Local redness, bruising or mild pain after an injection · Common
  • Possible allergic reactions, including rash or hives; stop use if these develop
  • Nausea, usually starting within one hour after injection and resolving within 12 hours · 40%
  • Flushing · Common
  • Headaches · Common
  • Temporary elevation of blood pressure · Common

Contraindications

  • Do not administer more than one dose within 24 hours.

PT-141: approved in the US; 503A compounding banned.

Regulatory status

  • US

    Approved

    FDA — Prescription Vyleesi is approved for HSDD in premenopausal women. Bremelanotide cannot be prepared by pharmacies operating under section 503A.

    Rx required
    Yes
    503A
    Banned
    Telehealth
    Available

Frequently asked questions

Which dosing approaches are discussed?

Starting research approaches use a low dose, with titration for the standard approach. Numeric amounts are unspecified. Both frequency and route depend on the protocol. These qualitative descriptions do not establish a dosing regimen; discuss any use with a qualified clinician.

What distinguishes bremelanotide from erectile-dysfunction drugs?

PT-141 acts in the brain through MC3R and MC4R receptors to influence desire and arousal. Viagra and Cialis act on peripheral blood vessels instead. Vyleesi is an FDA-approved prescription treatment for HSDD in women before menopause; that indication does not extend to every cause of sexual dysfunction.

What evidence concerns use in men?

Research on off-label use in men includes increased sexual desire and erections through central melanocortin signaling. Findings also include men whose erectile dysfunction did not respond to PDE5 inhibitors. Use outside the approved female HSDD indication requires a physician’s evaluation and prescription.

Which adverse effects are most relevant?

Nausea affects about 40% and generally starts during the first hour after injection, then resolves within 12 hours. Flushing, headache, reactions at the injection location and temporary rises in blood pressure are common. Effects vary with dose and are often manageable. Follow the FDA limit of no more than one administration in any 24-hour period.

References

  1. Bremelanotide: New Drug for Treating Hypoactive Sexual Desire Disorder (2019)

  2. Hypoactive Sexual Desire Disorder in Women: Physiology, Assessment, Diagnosis, and Treatment. (2021)

    PMID 34510696DOI 10.1111/jmwh.13283

  3. Pharmacologic therapeutic options for sexual dysfunction. (2022)

    PMID 36036468DOI 10.1097/GCO.0000000000000821

  4. VYLEESI (bremelanotide injection) for subcutaneous use - Prescribing Information (2019)

  5. Bremelanotide (PT-141) studies on ClinicalTrials.gov (2024)