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Sexual HealthFDA-Approved

PT-141 (Bremelanotide)FDA-approved melanocortin agonist (Vyleesi)

Understand the mechanism, the current regulatory status, and the evidence — then decide your next step with a clinician who knows these compounds. The information below is educational reference only.

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Mechanism
Acts centrally at melanocortin receptors, including MC4R, involved in sexual response.
Benefits
Hypoactive sexual desire disorder · Sexual arousal pathways · Melanocortin signaling
Typical Dose
1.75 mg subcutaneously, at least 45 minutes before anticipated sexual activity
Frequency
No more than one dose in 24 hours; no more than eight doses per month
The essentials

At a Glance

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Compound type

Peptide drug

Researched for

Hypoactive sexual desire disorder, sexual arousal pathways and melanocortin signaling.

Evidence level

A — FDA-approved for a narrow indication

U.S. FDA status

FDA-approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women; not approved as a general libido or erectile-dysfunction drug.

Approved indication

Acquired, generalized hypoactive sexual desire disorder in premenopausal women.

Routes studied

Subcutaneous.

Doses studied

FDA-approved dose: 1.75 mg subcutaneously at least 45 minutes before anticipated sexual activity — no more than one dose in 24 hours and no more than eight doses per month.

Safety notes

Nausea, flushing, headache and transient blood-pressure increases can occur.

Anti-doping (WADA)

Check sport rules.

Availability at True Heal

True Heal Wellness offers PT-141 (Bremelanotide) as a clinician-supervised service. Any prescription follows a consultation and medical review.

Last reviewed

2026-08-11

Regulatory status

FDA-approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women; not approved as a general libido or erectile-dysfunction drug.

Approved indication: Acquired, generalized hypoactive sexual desire disorder in premenopausal women.

The Vyleesi approval covers premenopausal women with HSDD only; male and other off-label uses are not FDA-approved.

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What PT-141 (Bremelanotide) is

Melanocortin receptor agonist FDA-approved as Vyleesi for a specific form of low sexual desire in premenopausal women. It is also referred to as Bremelanotide and Vyleesi.

How it works

Acts centrally at melanocortin receptors, including MC4R, involved in sexual response.

What the evidence shows

Vyleesi has randomized-trial evidence for its approved HSDD indication; male ED/libido enhancement uses are not FDA-approved.

Evidence level: A — FDA-approved for a narrow indication.

Routes studied: Subcutaneous.

Doses studied: FDA-approved dose: 1.75 mg subcutaneously at least 45 minutes before anticipated sexual activity — no more than one dose in 24 hours and no more than eight doses per month.

What this page does not claim

The Vyleesi approval covers premenopausal women with HSDD only; male and other off-label uses are not FDA-approved.

Safety considerations

Nausea, flushing, headache and transient blood-pressure increases can occur.

  • Cautions and contraindications: Uncontrolled hypertension or known cardiovascular disease per label.
  • Possible interactions: May slow gastric emptying and affect some oral medications.

Sport and anti-doping

Check sport rules.

Availability at True Heal Wellness

True Heal Wellness offers PT-141 (Bremelanotide) as a clinician-supervised service. Any prescription follows a consultation and medical review.

Straight answers

Frequently asked

What is PT-141 (Bremelanotide)?

Melanocortin receptor agonist FDA-approved as Vyleesi for a specific form of low sexual desire in premenopausal women.

Is PT-141 (Bremelanotide) FDA-approved?

FDA-approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women; not approved as a general libido or erectile-dysfunction drug. The Vyleesi approval covers premenopausal women with HSDD only; male and other off-label uses are not FDA-approved.

What is PT-141 (Bremelanotide) researched for?

Hypoactive sexual desire disorder, sexual arousal pathways and melanocortin signaling.

What does the evidence on PT-141 (Bremelanotide) show?

Vyleesi has randomized-trial evidence for its approved HSDD indication; male ED/libido enhancement uses are not FDA-approved. Evidence level: A — FDA-approved for a narrow indication.

What are the safety considerations with PT-141 (Bremelanotide)?

Nausea, flushing, headache and transient blood-pressure increases can occur. Cautions: Uncontrolled hypertension or known cardiovascular disease per label.

Does True Heal Wellness offer PT-141 (Bremelanotide)?

True Heal Wellness offers PT-141 (Bremelanotide) as a clinician-supervised service. Any prescription follows a consultation and medical review.

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The evidence

References

  1. U.S. Food & Drug Administration — regulatory documentation. FDA record
  2. PepEd Hub — PT-141 (Bremelanotide) compound profile. pepedhub.com
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Medical disclaimer. For research and educational purposes only. This content does not constitute medical advice — consult a qualified healthcare provider before beginning any protocol.

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