HomePeptidesPT-141 (bremelanotide)
PT-141 (bremelanotide): what it is, what the studies show and where it stands
Bremelanotide (PT-141) is a synthetic cyclic seven-amino-acid peptide that activates melanocortin receptors. In the US it is sold as Vyleesi, an autoinjector used under the skin as needed by premenopausal women with acquired, generalized hypoactive sexual desire disorder.
At a glance
US Approved for one use
Canada Not authorized
Group Hormonal and sexual health
Sources 11
Checked 10 Oct 2026What is PT-141 (bremelanotide)?
Bremelanotide (PT-141) is a synthetic cyclic seven-amino-acid peptide that activates melanocortin receptors. In the US it is sold as Vyleesi, an autoinjector used under the skin as needed by premenopausal women with acquired, generalized hypoactive sexual desire disorder. [1]
Other names: bremelanotide, Vyleesi, BMT.
How it has been given to people: subcutaneous injection (the approved product); intranasal in early trials.
Looking for doses? PT-141 (bremelanotide) dosage chart and vial math
Is PT-141 (bremelanotide) approved in the US and Canada?
United States: FDA approved as Vyleesi (NDA 210557, approved 2019-06-21) for premenopausal women with acquired, generalized hypoactive sexual desire disorder. The label says it is not indicated for men or for postmenopausal women. [1]
Canada: No bremelanotide product is in Health Canada's Drug Product Database. Health Canada has named bremelanotide and PT-141 among seized unauthorized injectable peptide drugs. [11]
Both were checked on 10 Oct 2026 against the regulators' own product databases.
Which approved products contain PT-141 (bremelanotide)?
| Product | Country | Approved for | Label |
|---|---|---|---|
| Vyleesi | US | premenopausal women with acquired, generalized hypoactive sexual desire disorder | Label |
What human studies of PT-141 (bremelanotide) exist?
The 7 findings listed here: 4 from randomized human trials and 3 from smaller or observational human studies.
In two identical 24-week phase 3 trials, bremelanotide raised the sexual desire score more than placebo (by 0.30 and 0.42 points) and lowered the distress score more than placebo (by 0.37 and 0.29 points). [3]
On the label's own figures the desire score, which runs from 1.2 to 6.0, rose by a mean 0.5 points (Study 1) and 0.6 points (Study 2) on Vyleesi against 0.2 points on placebo in both. [1]
In the 12-week dose-finding trial, the 1.25 mg and 1.75 mg groups pooled gained 0.7 satisfying sexual events a month against 0.2 on placebo. [4]
An independent re-analysis of the two phase 3 trials, using the FDA application data, found that far more women stopped the study because of side effects on bremelanotide than on placebo and judged the benefit modest. [7]
In healthy men, subcutaneous doses above 1.0 mg produced a statistically significant erectile response, and 4 mg and 6 mg did so in men who responded poorly to sildenafil. This is not an approved use. [5]
An early intranasal form produced a significant erectile response in men only at doses above 7 mg; its half-life after nasal dosing was about 1.85 to 2.09 hours. No nasal product was approved. [8]
Of 856 women who finished the phase 3 trials, 684 entered a 52-week open-label extension and 272 completed it. No new safety signals were reported. [6]
What are the side effects of PT-141 (bremelanotide)?
Reported in human studies or on a label:
- Nausea is the most common side effect: 40% of women on Vyleesi in the phase 3 trials. It usually starts within an hour of the dose and lasts about two hours. [1]
- The label's list of the most common reactions. [1]
- Blood pressure rises and heart rate falls for a time after each dose, usually returning to baseline within 12 hours. [1]
- Dark patches of skin (face, gums, breasts) were reported in 1% of women using up to 8 doses a month, and in 38% of people dosed daily for 8 days. They did not always fade after stopping. [1]
- In the phase 3 trials 18% of women on Vyleesi stopped because of side effects, against 2% on placebo. [1]
- One case of acute hepatitis was reported in the open-label extension; liver tests returned to normal 4 months after stopping. [1]
Warnings on the label
- Contraindicated in uncontrolled high blood pressure or known cardiovascular disease. [1]
- No more than one dose within 24 hours, because doses close together may add to the blood pressure effect. [1]
- More than 8 doses a month is not recommended. [1]
- Not indicated for men or for postmenopausal women. [1]
- Not indicated to enhance sexual performance. [1]
- Interaction: avoid with naltrexone taken by mouth for alcohol or opioid addiction, because Vyleesi may sharply lower naltrexone levels. [1]
- Interaction: it may slow stomach emptying and reduce absorption of medicines taken by mouth. [1]
- Pregnancy: use effective contraception and stop if pregnancy is suspected. [1]
- Stop after 8 weeks if symptoms have not improved. [1]
- Taking ondansetron beforehand did not reduce nausea in a study of 228 women and is not recommended. [1]
What is the half-life of PT-141 (bremelanotide)?
About 2.7 hours after a single subcutaneous dose (the label gives a range of 1.9 to 4.0 hours). Blood levels peak at about 1 hour. [1]
How does PT-141 (bremelanotide) compare with others in its group?
These are the peptides filed under hormonal and sexual health. The last column says whether a randomized human trial is on record for each.
| Peptide | US | Canada | Half-life | Randomized human trial |
|---|---|---|---|---|
| PT-141 (bremelanotide) | Approved for one use | Not authorized | About 2.7 hours after a single subcutaneous dose (the label gives a range of 1.9 to 4.0 hours). Blood levels peak at about 1 hour. | Yes |
| Kisspeptin-10 | Not approved | Not authorized | Not found | Yes |
| Gonadorelin | No longer sold | No longer sold | Very short. After intravenous or subcutaneous injection, blood levels fall with an initial half-life of 2 to 10 minutes and a terminal half-life of 10 to 40 minutes. | No |
| Testagen | Not approved | Not authorized | Not found | No |
| HCG | Approved, prescription | Authorized, prescription | About 32 to 33 hours after a single injection of 5,000 or 10,000 IU in 18 healthy women, the same by muscle or under the skin. | Yes |
| HMG | Approved, prescription | Authorized, prescription | FSH from Menopur had an elimination half-life of 11 to 13 hours after repeated doses, by injection under the skin or into a muscle. The label gives no half-life for the LH part. | Yes |
What could not be found
These were searched for and did not turn up. They are listed so a missing number is not mistaken for a hidden one.
- No Health Canada authorization: ingredient and brand lookups in the Drug Product Database returned nothing.
- No approved dose for men or for postmenopausal women. The label says it is not indicated for either.
- No approved nasal or oral product. Intranasal amounts from the early trial are not listed as dose rows because the abstract gives only a threshold (above 7 mg).
- How long one dose keeps working: the label says the duration of efficacy after each dose is unknown.
- Numbers of men in the phase 1 and sildenafil-failure studies are not given in the abstract.
- Bremelanotide is not named in the WADA 2026 Prohibited List. Whether any general class of the list covers it was not determined.
PT-141 (bremelanotide) questions
Is PT-141 (bremelanotide) approved in the US?
FDA approved as Vyleesi (NDA 210557, approved 2019-06-21) for premenopausal women with acquired, generalized hypoactive sexual desire disorder. The label says it is not indicated for men or for postmenopausal women.
Is PT-141 (bremelanotide) authorized in Canada?
No bremelanotide product is in Health Canada's Drug Product Database. Health Canada has named bremelanotide and PT-141 among seized unauthorized injectable peptide drugs.
What is the half-life of PT-141 (bremelanotide)?
About 2.7 hours after a single subcutaneous dose (the label gives a range of 1.9 to 4.0 hours). Blood levels peak at about 1 hour.
Has PT-141 (bremelanotide) been tested in a randomized human trial?
Yes. At least one randomized human trial is listed on this page.
Sources
Each one was opened on 10 Oct 2026 and matched to the line it supports.
- Cosette Pharmaceuticals, Inc. VYLEESI (BREMELANOTIDE) INJECTION [COSETTE PHARMACEUTICALS, INC.] 2025. api.fda.gov.
- US Food and Drug Administration Drugs@FDA (openFDA drugsfda endpoint): VYLEESI, NDA210557 2026. api.fda.gov.
- Kingsberg SA et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol 2019. PubMed 31599840. Trial NCT02333071; NCT02338960.
- Clayton AH et al. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond) 2016. PubMed 27181790. Trial NCT01382719.
- Rosen RC et al. Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to Viagra. Int J Impot Res 2004. PubMed 14999221.
- Simon JA et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol 2019. PubMed 31599847. Trial NCT02333071; NCT02338960.
- Spielmans GI Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women. J Sex Res 2021. PubMed 33678061.
- Diamond LE et al. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction. Int J Impot Res 2004. PubMed 14963471.
- Health Canada Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks 2025. recalls-rappels.canada.ca.
- Health Canada Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary, Alberta may pose serious health risks 2025. recalls-rappels.canada.ca.
- Health Canada Drug Product Database (API): active ingredient lookup for BREMELANOTIDE and brand lookup for VYLEESI 2026. health-products.canada.ca.
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PT-141 (bremelanotide) dosage10 mg vialHormonal and sexual healthStatus in Canada
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