PT-141
PT-141 is the research name for bremelanotide, approved only as Vyleesi, an autoinjector for low sexual desire with distress in some premenopausal women.
US regulatory status
FDA-approved for a different use
Bremelanotide is FDA-approved only as Vyleesi, a 1.75 mg single-dose autoinjector for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The label says it is not indicated for men, for postmenopausal women or to enhance sexual performance. Nasal sprays and powder vials sold as “PT-141” are unapproved drugs, and in August 2026 the FDA sent warning letters to three websites selling them.
At a glance
- Also known as
- Bremelanotide, Vyleesi
- Supplied as
- Several forms, depending on the product
- US status
- US status: Approved for one usechecked
What the research shows
Evidence grade
Strong human evidence (approved use only)
Consistent results from large randomized controlled trials in people.
For its approved use, the evidence is two identical 24-week phase 3 trials (RECONNECT) in premenopausal women with acquired, generalized HSDD, each followed by a 52-week open-label extension. Of 1,267 women randomized, 1,247 were in the safety population and 1,202 in the efficacy analysis. In both trials, bremelanotide raised the desire score (FSFI desire domain) and lowered distress about low desire (FSDS-DAO item 13) more than placebo; in the integrated analysis, the placebo-adjusted changes were +0.35 for desire and −0.33 for distress (both P<.001). The number of satisfying sexual events, a secondary endpoint, did not differ significantly from placebo. The label says how it improves HSDD is unknown. There is no approved use in men or after menopause, and no approval establishes that it works outside the approved indication.
How we grade evidence
Strong human evidence · this page
Consistent results from large randomized controlled trials in people.
Limited human evidence
Some studies in people, but they are small, short, early-phase or uncontrolled.
Mixed evidence
Studies in people disagree, or strong evidence for one use sits beside weak evidence for another.
Animal or lab studies only
Studied in cells or animals, not properly in people. Animal results may not apply to humans.
The grade describes how much research exists and in whom. It is not a judgment that a compound works or is safe.
Side effects and safety
In the phase 3 trials (627 women on Vyleesi, 620 on placebo), the most common side effects were nausea (40% vs 1.3%), flushing (20.3% vs 0.3%), injection-site reactions (13.2% vs 8.4%) and headache (11.3% vs 1.9%); 18% stopped because of side effects, compared with 2% on placebo. Each dose caused maximal blood pressure increases of 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours later, and lowered heart rate by up to 5 beats per minute, usually back to baseline within 12 hours. The label contraindicates it with uncontrolled high blood pressure or known cardiovascular disease. Darkening of the skin, including the face, gums and breasts, occurred in 1% of women using up to 8 doses a month and in 38% in a study of daily use for 8 days; it was more likely with dark skin and did not always fade after stopping. Vyleesi may slow stomach emptying, can sharply lower blood levels of oral naltrexone, and should be stopped if pregnancy is suspected. One case of acute hepatitis in the extension study could not be ruled out as drug-related. Products sold as “PT-141” outside a pharmacy are unapproved, so their identity, purity and sterility are not verified.
Vial math
Pre-filled calculators turn your vial, water and prescribed dose into syringe units.
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Questions people ask
What is PT-141?
PT-141 is the development name for bremelanotide, a synthetic ring-shaped peptide of seven amino acids that activates melanocortin receptors, mainly MC1R and MC4R at approved doses. The approved product is Vyleesi, marketed by Cosette Pharmaceuticals. Researchers describe bremelanotide as a variation of melanotan II designed for sexual stimulation: both act on melanocortin receptors, but only bremelanotide has an FDA-approved product.
Is PT-141 approved for women or for men?
Only for some women. Vyleesi is approved for premenopausal women with acquired, generalized HSDD: low sexual desire that causes marked distress or relationship difficulty, began after a time without problems, happens in every situation, and is not due to another medical or psychiatric condition, relationship problems, or a medicine. The label says it is not indicated in men, in postmenopausal women, or to enhance sexual performance. No approval establishes that it works in men.
Is there an FDA-approved PT-141 nasal spray?
No. The only FDA-approved bremelanotide product listed on DailyMed is the Vyleesi autoinjector, injected under the skin. An FDA import alert lists a “PT 141 Peptide” entry because there is no FDA-approved application in effect for “PT-141”; the approved product is Vyleesi, under the bremelanotide name. In August 2026, the FDA also warned three websites that their PT-141 products were unapproved new drugs, despite “research use only” labels.
Sources
- DailyMed, U.S. National Library of Medicine, 2025: VYLEESI (bremelanotide) injection, prescribing information (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Import Alert 66-41: Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Warning letter: TXP Innovations LLC dba Tex Peptides (MARCS-CMS 735067) (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Warning letter: Peak Performance Peptides (MARCS-CMS 735127) (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Warning letter: NuScience Peptides LLC (MARCS-CMS 733652) (opens in a new tab)
What are the side effects of PT-141?
Nausea is the main one: 40% of women in the Vyleesi trials, 13% needed anti-nausea medicine and 8% stopped because of it. It usually began within an hour of a dose and lasted about two hours, and it was most common after the first dose (21%), falling to about 3% after later doses. Taking ondansetron beforehand did not prevent it. Flushing, headache and injection-site reactions were also common. Blood pressure rises and heart rate drops for some hours after each dose, and some people develop darker patches on the face, gums or breasts that may not fade. With alcohol, flushing was more common than with alcohol alone, and headache more common than with bremelanotide alone.
How is Vyleesi used, and how long does it last?
The label’s directions, which your prescriber applies to you: one 1.75 mg injection under the skin of the abdomen or thigh, as needed, at least 45 minutes before expected sexual activity; no more than one dose in 24 hours; more than 8 doses a month is not recommended; and stop after 8 weeks if symptoms haven’t improved. How long the effect lasts after a dose is unknown. Blood levels peak about 1 hour after the injection, and the half-life is about 2.7 hours (range 1.9 to 4.0). Store it at or below 25°C (77°F), don’t freeze it, and keep it out of light. Follow your prescriber’s instructions.
Is a 10 mg PT-141 vial the same as Vyleesi?
No. Vyleesi is 1.75 mg of bremelanotide in 0.3 mL, ready to inject in a single-dose autoinjector that comes in cartons of 2 or 4; there is no vial and no water to add. A 10 mg powder vial is not an approved product, and the FDA has called such “PT-141” products unapproved new drugs. Its concentration depends on how much water is added, so unit readings don’t carry over from one to the other. The PT-141 10 mg calculator shows the mixing arithmetic for a vial; confirm any numbers with a licensed prescriber or pharmacist.
Sources
- VYLEESI (bremelanotide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
- Warning letter: TXP Innovations LLC dba Tex Peptides (MARCS-CMS 735067)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Warning letter: Peak Performance Peptides (MARCS-CMS 735127)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Warning letter: NuScience Peptides LLC (MARCS-CMS 733652)U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 TrialsObstet Gynecol, 2019 · Accessed Oct 16, 2026 (opens in a new tab)
- Bremelanotide: First ApprovalDrugs, 2019 · Accessed Oct 16, 2026 (opens in a new tab)
- Melanotan II injection resulting in systemic toxicity and rhabdomyolysisClin Toxicol (Phila), 2012 · Accessed Oct 16, 2026 (opens in a new tab)
- Import Alert 66-41: Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
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