Summary
PT-141 (bremelanotide) is a melanocortin receptor agonist approved by FDA in 2019 as Vyleesi, an on-demand subcutaneous injection for premenopausal women with acquired, generalized hypoactive sexual desire disorder. In the two RECONNECT phase 3 trials (1,267 women randomized), it raised the Female Sexual Function Index desire score by about 0.35 points more than placebo over 24 weeks, a statistically significant but small effect, with nausea in roughly 40% of users. Intranasal development for erectile dysfunction in men was stopped over blood pressure effects, so use in men is off-label and unsupported by an approved product.
What is PT-141 (bremelanotide)?
PT-141 (bremelanotide) is a cyclic heptapeptide melanocortin receptor agonist (MC4R and MC3R), an active metabolite of Melanotan II. It is also known as Bremelanotide, Vyleesi, PT-141, Bremelanotide acetate, PT 141, PT141, PT-141 peptide, PT 141 peptide.
How does it work?
Bremelanotide activates melanocortin receptors, chiefly MC4R and to a lesser extent MC3R, in hypothalamic and other central circuits involved in sexual arousal and appetite. Unlike PDE5 inhibitors it acts centrally rather than on penile blood flow. Melanocortin activation also stimulates MC1R on melanocytes, which explains focal skin darkening, and produces transient increases in blood pressure and decreases in heart rate after each dose.
| Cluster | Sexual health and reproductive |
|---|---|
| Routes | Subcutaneous injection by autoinjector, on demand (Vyleesi); Intranasal (discontinued development program for men); Compounded subcutaneous vials and nasal sprays (not FDA approved formulations) |
| Conditions studied | Sexual dysfunction; Erectile dysfunction |
| Record | v3, draft, verified Sep 22, 2026 |
PT-141 benefits: what the evidence shows
Two identical 24 week randomized, double-blind, placebo-controlled phase 3 trials (RECONNECT, studies 301 and 302) in premenopausal women with hypoactive sexual desire disorder showed statistically significant increases in the FSFI desire domain (0.30 and 0.42 points versus placebo; integrated 0.35) and reductions in desire related distress (minus 0.37 and minus 0.29 on the FSDS-DAO item 13). Independent reanalysis has questioned the clinical meaningfulness of these effects. In men, small phase 1 and 2 studies of intranasal PT-141 showed erectile responses, including in sildenafil non-responders, but the nasal program was discontinued and no product is approved for men.
| Evidence type | Indexed studies | Participants (human) |
|---|---|---|
| Human randomized trials | 4 | 1267 |
| Human observational studies | 1 | n/a |
| Animal studies | 0 | n/a |
| All indexed studies | 5 | 1,267 |
Human evidence
RECONNECT (Kingsberg 2019): 1,267 premenopausal women randomized 1:1 to bremelanotide 1.75 mg subcutaneously as needed or placebo for 24 weeks; sexual desire increased by 0.30 (study 301) and 0.42 (study 302) points versus placebo, and distress fell by 0.37 and 0.29 points; nausea, flushing, and headache each affected 10% or more of treated women. A 52 week open-label extension (Simon 2019) reported sustained effects and no new safety signals. Diamond 2004: double-blind, placebo-controlled intranasal PT-141 in healthy men and men with mild to moderate erectile dysfunction produced erectile responses. Safarinejad 2008: randomized, double-blind study in men who had failed sildenafil reported improved erectile function with intranasal bremelanotide. The nasal route was abandoned because of blood pressure increases.
Animal evidence
Rodent and primate studies established that melanocortin agonists including bremelanotide produce penile erection and increase female solicitation behaviors through central MC4R signaling. Rodent data also underlie the observed increases in blood pressure and decreases in food intake.
Key studies
| Study | Design and population | Outcome | Grade |
|---|---|---|---|
| Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials (RECONNECT)2019 PMID 31599840 | Two identical randomized, double-blind, placebo-controlled trials, 24 weeksn = 1,267 Premenopausal women with acquired, generalized hypoactive sexual desire disorder | FSFI desire domain increased 0.30 and 0.42 points versus placebo; distress (FSDS-DAO item 13) decreased 0.37 and 0.29 points versus placebo; nausea, flushing, and headache in 10% or more | Evidence: Human RCT evidence |
| Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder2019 PMID 31599847 | 52 week open-label extension of the RECONNECT trialsPremenopausal women who completed the double-blind phase | Improvements in desire and distress were maintained; no new safety signals | Evidence: Human observational evidence |
| Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141 in healthy males and patients with mild-to-moderate erectile dysfunction2004 PMID 14963471 | Double-blind, placebo-controlled phase 1 and 2a studies of intranasal PT-141Healthy men and men with mild to moderate erectile dysfunction | Intranasal PT-141 produced erectile responses measured by RigiScan; transient blood pressure effects noted | Evidence: Human RCT evidence |
| Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study2008 PMID 18206919 | Randomized, double-blind, placebo-controlled trial of intranasal bremelanotideMen with erectile dysfunction who had not responded to sildenafil | Intranasal bremelanotide improved erectile function scores compared with placebo in sildenafil non-responders | Evidence: Human RCT evidence |
| Small effects, questionable outcomes: bremelanotide for hypoactive sexual desire disorder2024 PMID 36809187 | Critical reanalysis of the phase 3 trial dataRECONNECT trial participants | Argues that the statistically significant changes in desire and distress are below thresholds for clinical meaningfulness | Evidence: Human RCT evidence |
Conditions studied
| Condition | Grade | Note |
|---|---|---|
| Sexual dysfunction | Evidence: Human RCT evidence | FDA approved as Vyleesi (2019) for premenopausal women with hypoactive sexual desire disorder; modest effect sizes in the RECONNECT trials. |
| Erectile dysfunction | Evidence: Human RCT evidence | Intranasal bremelanotide improved erectile function over placebo in men who had not responded to sildenafil; the FDA approval (Vyleesi) covers only premenopausal women with low sexual desire. |
Is PT-141 (bremelanotide) legal in the United States?
FDA and compounding status
FDA approved as Vyleesi (bremelanotide injection) on June 21, 2019, for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Because bremelanotide is the active ingredient of an approved drug, some 503A pharmacies compound it under the approved drug component pathway, but compounded PT-141 vials and nasal sprays are not FDA approved formulations, have not been tested for potency or sterility by FDA, and the nasal route was abandoned by the sponsor over blood pressure effects. Use in men is off-label.
WADA status
Not WADA prohibited. Not named on the current prohibited list. Athletes should still confirm against the list in force for their season.
Regulatory timeline
- FDA
FDA approves Vyleesi (bremelanotide) for hypoactive sexual desire disorder
FDA approved bremelanotide injection (Vyleesi), a melanocortin receptor agonist, for premenopausal women with acquired, generalized hypoactive sexual desire disorder.
Regulatory: FDA approvedSource: Drugs@FDA: Vyleesi (bremelanotide) NDA 210557
Full tracker for PT-141 (bremelanotide) or the category-wide tracker.
PT-141 (Vyleesi) dose on the FDA label
Doses below are quoted from the FDA label for its approved uses, plus the doses used in the pivotal trials where noted. The prescriber sets the dose; PeptideAgent does not recommend doses or protocols.
FDA label (Vyleesi, DailyMed): 1.75 mg injected subcutaneously into the abdomen or thigh at least 45 minutes before anticipated sexual activity, no more than one dose in 24 hours and no more than eight doses per month. RECONNECT used the same regimen.
Routes reported
| # | Route |
|---|---|
| 1 | Subcutaneous injection by autoinjector, on demand (Vyleesi) |
| 2 | Intranasal (discontinued development program for men) |
| 3 | Compounded subcutaneous vials and nasal sprays (not FDA approved formulations) |
PT-141 side effects
Side effects
| # | Reported side effect |
|---|---|
| 1 | Nausea (about 40% in trials, most often after the first dose; 13% needed an antiemetic) |
| 2 | Flushing (about 20%) |
| 3 | Injection site reactions (about 13%) |
| 4 | Headache (about 11%) |
| 5 | Vomiting, cough, fatigue, hot flush, paresthesia, dizziness, nasal congestion |
| 6 | Transient increase in blood pressure (about 6 mmHg systolic and 3 mmHg diastolic) and decrease in heart rate peaking 2 to 4 hours after each dose |
| 7 | Focal hyperpigmentation of the face, gums, or breasts (about 1%, more common with more than 8 doses per month, may not resolve) |
Interactions
| # | Interaction |
|---|---|
| 1 | Oral naltrexone: bremelanotide slows gastric emptying and significantly lowered naltrexone exposure; the label advises against use in people relying on oral naltrexone for opioid or alcohol use disorder |
| 2 | Other oral drugs: absorption of drugs taken at the same time may be reduced (label cites indomethacin); separate dosing or monitor |
| 3 | Antihypertensives: additive blood pressure effects are not expected but the transient pressor effect should be considered |
Contraindications
| # | Contraindication |
|---|---|
| 1 | Uncontrolled hypertension or known cardiovascular disease |
| 2 | Pregnancy (label advises effective contraception; discontinue if pregnant) |
| 3 | Not indicated for postmenopausal women or men |
| 4 | Not indicated for low desire due to a medical or psychiatric condition, a relationship problem, or a medication |
How do people access PT-141 (bremelanotide) legally?
Typical cost: Vyleesi retail cash prices run about 930 to 956 USD per carton of four autoinjectors; the manufacturer savings program lists 0 USD for most commercially insured patients and 99 USD per carton without coverage. Compounded PT-141 nasal spray through a licensed telehealth program is about 187 to 224 USD per month. Prices checked 2026-09-22 and change often.
Verified access options
Step 1
Prescription from a licensed provider filled at a retail or specialty pharmacy as Vyleesi.
Step 2
Prescription filled by a 503A compounding pharmacy as compounded bremelanotide (not an FDA approved formulation).
Step 3
Telehealth clinics that prescribe compounded PT-141 for men or women off-label.
Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.
Compare PT-141 (bremelanotide)
Frequently asked questions
What is PT-141 peptide?
PT-141 is the development code for bremelanotide, a synthetic peptide that activates melanocortin receptors in the brain involved in sexual desire. FDA approved it as Vyleesi, an injection used as needed by premenopausal women with acquired, generalized hypoactive sexual desire disorder. It is not approved for men. [1] [6]
Is PT-141 legal and FDA approved?
Yes, as Vyleesi. FDA approved bremelanotide injection in June 2019 for premenopausal women with acquired, generalized hypoactive sexual desire disorder. It is prescription only. Compounded PT-141 vials and nasal sprays sold by telehealth clinics are not FDA approved formulations, and use in men or postmenopausal women is off-label. [6] [7]
Does PT-141 work for women with low libido?
It works a little. In the two RECONNECT trials (1,267 premenopausal women, 24 weeks), the FSFI desire score rose about 0.35 points more with bremelanotide than placebo and distress about low desire fell about 0.33 points more. Those differences were statistically significant, but an independent reanalysis argued they are too small to be clinically meaningful for most women, and about 40% of users had nausea. [1] [5]
Does PT-141 work for erectile dysfunction in men?
Small early studies of intranasal PT-141 showed erectile responses in healthy men and men with erectile dysfunction, including a randomized trial in men who had failed sildenafil. The sponsor stopped the nasal program because of blood pressure increases, and no product is approved for men. Any use in men today is off-label with compounded product and no approved dosing. [3] [4] [6]
What are the side effects of PT-141?
Nausea is the main one, affecting about 40% of women in trials, usually after the first dose; about 13% needed an anti-nausea drug. Flushing (20%), injection site reactions (13%), and headache (11%) are common. Each dose transiently raises blood pressure by about 6 mmHg systolic and lowers heart rate, so it is contraindicated with uncontrolled hypertension or known cardiovascular disease. About 1% develop focal darkening of the face, gums, or breasts, which may be permanent. [1] [6]
What is the PT-141 (Vyleesi) dose on the FDA label?
The Vyleesi label dose is 1.75 mg injected under the skin of the abdomen or thigh with the prefilled autoinjector, as needed, at least 45 minutes before anticipated sexual activity. No more than one dose should be used in 24 hours, and more than 8 doses a month is not recommended. The label notes that how long each dose works is unknown. Compounded PT-141 vials and nasal sprays use the same peptide but are not FDA approved formulations and have no labeled dose. [6]
How much does PT-141 cost?
Vyleesi costs about 930 to 956 USD cash for four autoinjectors, but the manufacturer savings program lists 0 USD for most commercially insured patients and 99 USD per carton for patients without coverage. Compounded PT-141 nasal spray through a licensed telehealth program is about 187 to 224 USD per month. Prices checked 2026-09-22. [6] [10] [11] [12]
Is PT-141 banned by WADA?
No. Bremelanotide is an approved medicine and is not named in any section of the WADA Prohibited List. Athletes should still check with their anti-doping organization, and note that compounded products may contain other substances. [9]
PT-141 vs Melanotan II: what is the difference?
PT-141 is a metabolite of Melanotan II with the same core structure but without the C-terminal amide. Melanotan II is a nonselective melanocortin agonist that tans skin and was never approved anywhere; it produced erections in two tiny crossover trials and was withdrawn from the FDA Category 2 compounding list in April 2026. PT-141 is more selective for MC4R, is FDA approved for women, and has large randomized trials. Neither is approved for men. [1] [8]
Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.
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- Peptides for men, ranked by human evidence
hCG, GLP-1 drugs, teriparatide, and tesamorelin have human trials and a lawful route. PT-141 is off-label for men, and kisspeptin and melanotan II have no lawful path. Ranking, legality, and WADA.
- Peptides for women, ranked by human evidence
GLP-1 drugs, teriparatide, abaloparatide, and Vyleesi (PT-141) have real trials in women. Kisspeptin is research-only and GHK-Cu rests on small skin studies. The ranking and legal status.
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]Kingsberg SA et al. Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials. Obstet Gynecol 2019 (RECONNECT)PubMed 31599840, 2019
- [2]Simon JA et al. Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder. Obstet Gynecol 2019PubMed 31599847, 2019
- [3]Diamond LE et al. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141 in healthy males and patients with mild-to-moderate erectile dysfunction. Int J Impot Res 2004PubMed 14963471, 2004
- [4]Safarinejad MR, Hosseini SY. Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study. J Urol 2008PubMed 18206919, 2008
- [5]Spielmans GI. Small effects, questionable outcomes: bremelanotide for hypoactive sexual desire disorder. J Sex Res 2024PubMed 36809187, 2024
- [6]FDA prescribing information for Vyleesi (bremelanotide injection), via DailyMedFDA, 2025
- [7]FDA: Compounding and the FDA, questions and answersFDA, 2026
- [8]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
- [9]WADA Prohibited ListWADA, 2026
- [10]Published retail cash price listing for bremelanotide autoinjectors, accessed 2026-09-22
- [11]Vyleesi (bremelanotide) manufacturer patient site, savings program terms, accessed 2026-09-22
- [12]Licensed telehealth provider price page for compounded bremelanotide nasal spray, accessed 2026-09-22
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