PT-141 (Bremelanotide): A Melanocortin-Based Approach to Sexual Dysfunction

This content is provided by Superpower Health for educational and informational purposes only. Superpower Health facilitates access to compounded bremelanotide (PT-141) through licensed healthcare providers and compounding pharmacy partners. Compounded bremelanotide is NOT equivalent to the branded product (Vyleesi). Superpower does not sell, prescribe, or facilitate access to any branded version of bremelanotide. Compounded bremelanotide is a prescription medication available only by prescription. This page is not a substitute for medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider.

Viagra changed how medicine approaches erectile dysfunction. It did not change how medicine approaches desire. For the estimated 43% of women and 31% of men who experience sexual dysfunction rooted in drive rather than blood flow, the pharmacological options have been limited until recently.

PT-141 targets the brain rather than blood vessels. Here is what that means, who it is prescribed for, and what the clinical evidence supports.

Key takeaways

• Regulatory Status: FDA-approved in June 2019 as Vyleesi (bremelanotide injection, 1.75 mg) for hypoactive sexual desire disorder (HSDD) in premenopausal women. Also available as compounded bremelanotide through licensed 503A pharmacies with a patient-specific prescription. Compounded formulations such as sublingual troches use a different route of administration from the FDA-approved Vyleesi injection and are not considered "essentially a copy" under FDA guidance.
• Research Stage: Phase 3 RCT evidence (RECONNECT program); FDA-approved for HSDD
• Availability: Prescription only. Bremelanotide Rx is not available in all 50 states.
• Prescribing information: View full prescribing information — Vyleesi (DailyMed)
• How it works: Activates melanocortin receptors (primarily MC4R) in the central nervous system to modulate sexual desire and arousal signaling.
• What the research shows: In the RECONNECT Phase 3 RCT (N=1,267 premenopausal women), bremelanotide 1.75 mg SC administered on demand over 24 weeks improved FSFI desire domain scores by 0.35 points more than placebo (P<0.001) and reduced FSDS-DAO distress scores by 0.33 points more than placebo (P<0.001).

What is PT-141 (bremelanotide)?

Bremelanotide (marketed as Vyleesi; also known in peptide communities as PT-141) is a synthetic cyclic heptapeptide melanocortin receptor agonist. It is structurally derived from alpha-melanocyte-stimulating hormone (alpha-MSH) and binds primarily to melanocortin receptor subtypes MC1R, MC3R, and MC4R. Its primary clinical action is activation of MC4R in the hypothalamus and limbic system, which modulates the neural circuitry underlying sexual desire and arousal. It does not act on vascular smooth muscle, which is what distinguishes it mechanistically from PDE5 inhibitors such as sildenafil and tadalafil.

PT-141 was the compound designation used during the research and development phase before brand-name approval. Both names refer to the same molecule. Bremelanotide received FDA approval in June 2019 as Vyleesi for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. It is the second FDA-approved pharmacological treatment for HSDD, following flibanserin (Addyi) in 2015, and the first approved for on-demand use. It is also available as a compounded formulation through licensed 503A pharmacies.

PT-141 vs. PDE5 inhibitors (Viagra/cialis): Key differences

Bremelanotide activates brain-based melanocortin receptors; PDE5 inhibitors (sildenafil, tadalafil) act peripherally on vascular smooth muscle. This is a mechanistic distinction with direct clinical implications.

PDE5 inhibitors work by preventing the breakdown of cyclic GMP (cGMP) in smooth muscle cells, which sustains vasodilation and blood flow to genital tissues. They require sexual arousal to be present and operate primarily on the vascular response to desire. They address the physical mechanics of erection or engorgement — not the desire signal that precedes them. Bremelanotide acts on the central nervous system, specifically on the melanocortin pathway in the hypothalamus and limbic system, where sexual motivation is generated. It modulates desire and arousal as neural phenomena, not blood flow events. A comprehensive review published by Edinoff, Sanders, and colleagues in Neurology International in 2022 confirmed this mechanistic distinction in a full account of bremelanotide's pharmacology.

The practical implication is that the two compound classes address different components of sexual dysfunction. PDE5 inhibitors are appropriate when the dysfunction is primarily vascular (impaired engorgement or erection despite normal desire). Bremelanotide is indicated for low desire as the primary complaint, where blood flow is not the limiting factor. a 2025 review in Expert Opinion on Pharmacotherapy by Ila and Pozzi reviewed the landscape of peptides for erectile dysfunction, noting that compounds acting through distinct mechanisms from PDE5 inhibitors are particularly relevant for patients who do not respond to that class or whose dysfunction is desire-based. Cross-compound comparisons should be interpreted with attention to the specific populations, endpoints, and study designs involved.

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What bremelanotide is typically prescribed for

Bremelanotide (Vyleesi) is FDA-approved for the treatment of HSDD in premenopausal women. Providers evaluate candidates based on a clinical diagnosis of HSDD, defined as persistently low sexual desire causing personal distress, not attributable to a co-existing medical condition, psychiatric disorder, relationship problem, medication effect, or hormonal abnormality that would explain the symptom more parsimoniously. Key evaluation criteria include a full sexual function history, hormonal baseline (estradiol, testosterone, prolactin, SHBG), thyroid function, and a review of medications that may suppress desire (including certain antidepressants, hormonal contraceptives, and antihypertensives). Bremelanotide requires a prescription from a licensed provider.

Who should not use bremelanotide

A licensed provider will evaluate individual risk factors before prescribing. The following are contraindications or conditions requiring additional clinical scrutiny, based on the Vyleesi FDA prescribing information and published safety data:

• Uncontrolled hypertension or known cardiovascular disease — bremelanotide causes transient blood pressure increases that may be clinically significant in individuals with pre-existing cardiovascular risk
• High cardiovascular risk profile (multiple risk factors for major adverse cardiovascular events) — the prescribing information advises against use in this population due to the transient hemodynamic effects
• Postmenopausal women — bremelanotide is FDA-approved only for premenopausal women with HSDD; it has not been studied for efficacy and safety in postmenopausal populations
• Pregnancy or breastfeeding — safety has not been established; women who could become pregnant should use contraception during bremelanotide use
• Known hypersensitivity to bremelanotide or any component of the Vyleesi formulation
• Concurrent use of oral naltrexone — bremelanotide may significantly reduce the systemic exposure of orally administered naltrexone by slowing gastric motility, potentially compromising naltrexone therapy in patients being treated for alcohol or opioid dependence
• Individuals who require consistent blood pressure control for cardiovascular management — the transient BP elevation may complicate management

A licensed provider will evaluate individual risk factors, medication interactions, and hormonal status before prescribing bremelanotide.

Side effects and safety considerations

Bremelanotide's safety profile is well-characterized through the RECONNECT Phase 3 trials (N=1,267) and the 52-week open-label extension. Most adverse effects are dose-dependent and time-limited, resolving within hours of administration.

Common (reported in clinical studies):

• Nausea — the most frequently reported adverse effect; occurred in 40.0% of bremelanotide 1.75 mg recipients versus 1.3% on placebo in the Phase 3 RECONNECT trials (N=1,247 safety population) and in 40.4% of participants (N=684) in the 52-week open-label extension; typically onset within 30 minutes of dosing with a median duration of 2.4 hours; approximately 98% of cases were mild to moderate in severity
• Flushing — transient warmth or redness, particularly of the face; generally mild
• Injection-site bruising, pain, or erythema — common with subcutaneous administration; typically resolves within hours
• Headache — reported in approximately 9% of bremelanotide 1.75 mg recipients versus 5.6% on placebo in the Phase 3 RECONNECT trials (N=1,267)

Less common but reported:

• Transient blood pressure increase — in a randomized ambulatory monitoring study of 397 premenopausal women by White and Myers, bremelanotide 1.75 mg produced a mean systolic increase of approximately 2.5 to 3 mmHg versus placebo with peak effect in the 0-to-4-hour post-dose window, resolving within 12 hours; more pronounced in some individuals; contraindicated in uncontrolled hypertension (contact provider if blood pressure measurements are persistently elevated)
• Hyperpigmentation of the face, breasts, and gums with chronic use — related to bremelanotide's melanocortin receptor activity at MC1R (which governs pigmentation); risk increases with frequent use; the prescribing information limits use to no more than 8 doses per month to reduce hyperpigmentation risk, with no more than one dose per 24 hours
• Vomiting — associated with the nausea response in some patients; an antiemetic taken prior to bremelanotide may be considered per provider guidance

Is bremelanotide legal?

As of September 2026, bremelanotide is FDA-approved as Vyleesi (1.75 mg subcutaneous injection) for HSDD in premenopausal women. No other uses have been approved by the FDA. The safety and efficacy of bremelanotide for any use other than the approved HSDD indication in premenopausal women have not been established through adequate and well-controlled clinical trials reviewed by the FDA.

Bremelanotide is also available as a compounded formulation through licensed 503A compounding pharmacies with a patient-specific prescription from a licensed provider. The FDA-approved Vyleesi product and compounded bremelanotide are distinct from one another in terms of regulatory oversight: Vyleesi is subject to full FDA manufacturing standards; compounded bremelanotide is prepared under Section 503A compounding law.

Bremelanotide is not on the 2026 WADA Prohibited List by name. Athletes subject to anti-doping testing should nonetheless consult their governing body or a qualified anti-doping advisor, as WADA's prohibited list includes broad catch-all categories for peptides and peptide hormones that may encompass melanocortin agonists.

Test first, then decide

The principle of testing first, then deciding, is central to Superpower's approach to preventive health: the belief that every clinical decision should be grounded in what your bloodwork actually shows, not in symptoms alone. Understanding your hormonal baseline is the first step.

Frequently asked questions

How does PT-141 work differently from Viagra?

Bremelanotide (PT-141) activates melanocortin receptors in the hypothalamus and limbic system to modulate sexual desire as a brain-based signal. Viagra (sildenafil) inhibits PDE5 in vascular smooth muscle to maintain blood flow to genital tissue. Bremelanotide targets desire and arousal centrally; sildenafil targets the physical vascular response to desire. They act on different systems, address different components of sexual function, and are used in different patient populations.

Can women use PT-141?

Yes. Bremelanotide is FDA-approved specifically for use in premenopausal women with hypoactive sexual desire disorder (HSDD). The pivotal RECONNECT Phase 3 trials were conducted exclusively in premenopausal women (N=1,267). The compound has also been studied in early-phase trials for female sexual arousal disorder. Bremelanotide is not FDA-approved for use in postmenopausal women.

How quickly does PT-141 take effect?

Peak plasma concentrations occur approximately 1 hour after subcutaneous injection. Individual onset may vary.

What are the side effects of PT-141?

The most common side effects reported in the RECONNECT Phase 3 trials were nausea (approximately 40% of recipients), flushing, headache, and injection-site reactions. A transient increase in blood pressure occurs within 12 hours of injection in most users and resolves within 12 hours. Hyperpigmentation of the face, breasts, and gums has been reported with chronic or frequent use. Vomiting occurred in a subset of those who experienced nausea.

Is PT-141 FDA-approved?

Bremelanotide is FDA-approved as Vyleesi (1.75 mg subcutaneous injection) for HSDD in premenopausal women. This is the only FDA-approved indication. It has not been approved for use in men or in postmenopausal women. Compounded bremelanotide is also available through licensed 503A pharmacies with a patient-specific prescription, and is distinct from the FDA-approved Vyleesi product in terms of regulatory oversight.

Is compounded bremelanotide the same as Vyleesi?

No. Vyleesi is the FDA-approved brand-name product (1.75 mg subcutaneous injection) manufactured under full FDA quality and manufacturing standards. Compounded bremelanotide is prepared by licensed 503A compounding pharmacies under Section 503A of the Federal Food, Drug, and Cosmetic Act, with a patient-specific prescription. The two have the same active compound but differ in regulatory oversight, manufacturing standards, and potentially in available doses or formulation options. Compounded medications are prepared by a licensed compounding pharmacy and are not FDA-approved. They have not been evaluated by the FDA for safety, efficacy, or quality in the same manner as commercially manufactured branded products. A licensed provider can advise on which form is appropriate for a given clinical situation.

IMPORTANT SAFETY INFORMATION

Bremelanotide is FDA-approved as Vyleesi for hypoactive sexual desire disorder (HSDD) in premenopausal women. Compounded PT-141 (bremelanotide) is NOT the FDA-approved product and has not been reviewed by the FDA for safety or efficacy. Compounded PT-141 may only be dispensed upon a prescriber's patient-specific determination that a change from the FDA-approved Vyleesi product is clinically necessary. Superpower is a technology platform; Superpower does not prescribe or dispense medications.

Contraindications: uncontrolled hypertension or cardiovascular disease; postmenopausal women (not studied); pregnancy or breastfeeding; concurrent use of oral naltrexone.

Warnings: transient blood pressure increase (~3 mmHg systolic, resolving within 12 hours); nausea (reported in 40% of clinical trial participants); hyperpigmentation risk with frequent use (max 8 doses/month).

Common side effects: nausea, flushing, headache, injection site reactions.

Full prescribing information on the FDA-approved product (Vyleesi) at dailymed.nlm.nih.gov.

This content is provided by Superpower Health for educational and informational purposes only. Superpower Health facilitates access to compounded bremelanotide (PT-141) through licensed healthcare providers and compounding pharmacy partners. Compounded bremelanotide is NOT equivalent to the branded product (Vyleesi). Superpower does not sell, prescribe, or facilitate access to any branded version of bremelanotide. Compounded bremelanotide is a prescription medication available only by prescription. This page is not a substitute for medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider.