Bremelanotide
(Vyleesi) — FDA-Approved
A melanocortin receptor agonist FDA-approved for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
Bremelanotide (Vyleesi) is an FDA-approved medication for hypoactive sexual desire disorder in premenopausal women. It requires specific physician evaluation and is not appropriate for all patients.
How Bremelanotide Works
Bremelanotide is a synthetic cyclic peptide that acts as an agonist at melanocortin receptors, primarily MC1R, MC3R, and MC4R. These receptors are distributed throughout the central nervous system and play important roles in regulating sexual function, energy homeostasis, and neuroendocrine signaling. Bremelanotide's mechanism of action is distinct from hormonal therapies: it works through the melanocortin and dopaminergic pathways in the brain, affecting the neural circuits involved in sexual desire rather than manipulating hormone levels directly.
The FDA approved bremelanotide under the brand name Vyleesi in June 2019 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by a persistent or recurring deficiency of sexual desire that causes marked distress or interpersonal difficulty. It is a recognized medical condition distinct from normal fluctuations in libido, and it requires formal diagnosis by a qualified physician.
In clinical trials, bremelanotide demonstrated statistically significant improvements in sexual desire and reductions in distress associated with low sexual desire compared to placebo. It is administered as a subcutaneous injection on an as-needed basis, at least 45 minutes before anticipated sexual activity. Patients should not use more than one dose within 24 hours or more than 8 doses per month, as specified in the FDA-approved prescribing information.
FDA-Approved Indication
Treatment of HSDD
FDA-approved for acquired, generalized hypoactive sexual desire disorder in premenopausal women, as diagnosed by a qualified physician.
Sexual Health & Desire
Addresses reduced sexual desire through melanocortin and dopaminergic pathways in the brain, working at the neural level rather than hormonal.
Who Bremelanotide Is For
Premenopausal Women with HSDD
Women who have been diagnosed with acquired, generalized hypoactive sexual desire disorder by a qualified physician and are seeking an FDA-approved treatment option.
Physician-Referred Patients
Patients who have discussed their symptoms with a healthcare provider and have been evaluated for potential underlying causes. A dedicated eligibility evaluation is required.
Dedicated Eligibility Evaluation
Bremelanotide requires a specialized physician evaluation that is separate from our standard peptide protocol assessments. This evaluation includes a comprehensive review of your medical history, current medications, and a formal assessment for HSDD diagnosis. Not all patients will be eligible for this medication.
Request Eligibility Evaluation →Scientific Context
Bremelanotide was developed from research into melanocortin peptides, a family of neuropeptides that regulate diverse physiological functions including pigmentation, inflammation, energy homeostasis, and sexual function. Early observations during clinical trials of a related compound (Melanotan II, a tanning agent) revealed unexpected effects on sexual arousal, which led to the focused development of bremelanotide specifically for sexual dysfunction.
The FDA approval of bremelanotide (Vyleesi) in June 2019 was based on two randomized, double-blind, placebo-controlled Phase 3 clinical trials (RECONNECT) involving over 1,200 premenopausal women with HSDD. These studies demonstrated statistically significant improvements in sexual desire (measured by the Female Sexual Function Index desire domain) and significant reductions in distress associated with low sexual desire (measured by the Female Sexual Distress Scale). The most common side effects were nausea, flushing, injection site reactions, and headache. Bremelanotide is not approved for use in men or postmenopausal women.
Frequently Asked Questions
Is bremelanotide FDA-approved?
Yes. Bremelanotide was approved by the FDA in June 2019 under the brand name Vyleesi for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
What is HSDD?
Hypoactive Sexual Desire Disorder (HSDD) is a recognized medical condition characterized by a persistent or recurrent deficiency or absence of sexual desire that causes marked personal distress or interpersonal difficulty. It is not simply low libido; it requires a formal diagnosis by a qualified healthcare provider who rules out other potential causes.
How is bremelanotide administered?
Bremelanotide is administered as a subcutaneous injection in the abdomen or thigh, at least 45 minutes before anticipated sexual activity. Per FDA prescribing information, patients should not use more than one dose in 24 hours or more than 8 doses per month.
Is bremelanotide appropriate for everyone?
No. Bremelanotide is specifically approved for premenopausal women with diagnosed HSDD. It is not approved for men, postmenopausal women, or for the enhancement of sexual performance in healthy individuals. It is also contraindicated in patients with uncontrolled hypertension or known cardiovascular disease. A thorough physician evaluation is required.
What are the common side effects?
The most commonly reported side effects in clinical trials were nausea (40%), flushing (20%), injection site reactions (13%), and headache (11%). Nausea was the most common reason for discontinuation. Your physician will discuss the full risk-benefit profile during your evaluation.
Is a separate evaluation required for bremelanotide?
Yes. Bremelanotide requires a dedicated eligibility evaluation that includes a comprehensive review of your medical history, current medications, and a formal HSDD assessment. This evaluation is separate from our standard peptide protocol assessments.
Individual results may vary. This information is for educational purposes only. All peptide therapies require a physician evaluation and prescription.
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A physician will evaluate whether bremelanotide is appropriate for your diagnosis.
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