Label and approval explainer

PT-141 and bremelanotide: what the Vyleesi approval covers

By the Decadewise team Education only Last updated 29 July 2026 Label facts, not a protocol

Short answer

The approved product: bremelanotide is the active ingredient and Vyleesi is the approved product, approved by FDA under NDA 210557 in a letter signed 21 June 2019. PT-141 is the development code for the same molecule.

The indication, in full: premenopausal women with acquired, generalized hypoactive sexual desire disorder, where low desire causes marked distress or interpersonal difficulty and is not due to another condition, a relationship problem, or another drug.

What the label excludes: the Limitations of Use state the product is not indicated for HSDD in postmenopausal women or in men, and is not indicated to enhance sexual performance.

The class: a melanocortin receptor agonist that nonselectively activates several subtypes, with binding at MC1R and MC4R described as most relevant.

The gap this page exists for: approval attaches to one product, one population, one indication. It does not travel with the molecule.

On this page

Short answer What does the label say? What the approval excludes The mechanism The trial record Is PT-141 the same drug? Is it approved for men? Is PT-141 legal to buy? Is it on the WADA list? What is unsettled The safety picture How this is sourced Related pages The disclaimer

What does the Vyleesi label specify?

How to read this: every row is text from the approved prescribing information for that product, revised March 2024. None of it is guidance to anyone reading this page.

The approved label, section by section

Label section	What it states
1, indications	premenopausal women with acquired, generalized HSDD, not due to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication or drug substance
1, limitations of use	not indicated for HSDD in postmenopausal women or in men; not indicated to enhance sexual performance
2.1, dosage	1.75mg subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity; not more than one dose within 24 hours; more than 8 doses per month is not recommended
3, dosage form	1.75mg in 0.3mL, a clear solution in a single-dose autoinjector
4, contraindications	contraindicated in patients with uncontrolled hypertension or known cardiovascular disease
5.1, blood pressure	maximal increases of 6 mmHg systolic and 3 mmHg diastolic peaking 2 to 4 hours after a dose, heart rate down up to 5 beats per minute, returning to baseline usually within 12 hours
5.2, hyperpigmentation	reported in 1 percent of patients at up to 8 doses per month; in a separate study 38 percent developed focal hyperpigmentation after 8 consecutive daily doses
6.1, discontinuation	18 percent of treated patients stopped for adverse reactions against 2 percent on placebo
legend	Rx only, a prescription drug

Every figure in this table is printed in the approved prescribing information under the section named beside it.

The detail most summaries drop: the label states the duration of efficacy after each dose is unknown and the optimal window has not been fully characterized. That uncertainty is in the approved text.

What an approval covers, and what it does not

The unit of approval: a product, at a strength, in a delivery device, for a population, for an indication. Not a molecule.

Inside the approval

Population: premenopausal women with acquired, generalized HSDD as the label defines it.

Product: one strength in one single-dose autoinjector, released against a specification and a batch record.

Controls: a contraindication, three warnings, a pregnancy exposure registry, and a prescriber.

Outside the approval

Population: men and postmenopausal women, both named in the Limitations of Use.

Purpose: performance enhancement, also named in the Limitations of Use.

Product: anything labeled PT-141 that is not the approved product, which carries no approved specification and no label.

The point worth holding: a compound having an approved use somewhere is the weakest possible evidence about a different use, a different population, or a different vial.

The mechanism, and where the name PT-141 came from

The class: the label states bremelanotide is a melanocortin receptor agonist that nonselectively activates several subtypes in the order MC1R, MC4R, MC3R, MC5R, MC2R, and that at therapeutic levels binding to MC1R and MC4R is most relevant.

The origin: PT-141 was described in 2003 as a synthetic analogue of alpha-MSH acting at melanocortin receptors expressed mainly in the central nervous system (Molinoff, 2003). The early clinical work was in men with erectile dysfunction, by injection and by nasal spray (Diamond, 2004; Rosen, 2004).

Where that program went: the approval that arrived sixteen years later was for a different population and a different indication. The MC1R activity is also the reason skin pigmentation shows up in the warnings.

The honest bit: the approved label states, in section 12.1, that the mechanism by which the product improves HSDD in women is unknown.

The trials behind the approval

What the phase 3 program measured

The design: two identical 24-week randomized, double-blind, placebo-controlled trials, together named RECONNECT, registered as NCT02333071 and NCT02338960 (Kingsberg, 2019).

RECONNECT, the two co-primary endpoints

Measure	Study 301	Study 302
change in sexual desire score against placebo	+0.30, p<.001	+0.42, p<.001
change in distress related to low desire	-0.37, p<.001	-0.29, p=.005
randomized	1,267 women, 1,247 in the safety population, 1,202 in the modified intent-to-treat population
mean age	39 years

Both trials were funded by the developers. Both used the Female Sexual Function Index desire domain and one distress item as co-primary endpoints.

The effect size, plainly: statistically significant on both endpoints in both trials, and small in absolute terms. The approved label adds, in section 14, that there was no significant difference between the treatment groups in the change from baseline in the number of satisfying sexual events, a secondary endpoint.

Is PT-141 the same thing as Vyleesi?

Same molecule, different objects. PT-141 is the development code for bremelanotide; Vyleesi is the approved drug product built from it, which means a defined strength, a defined solution, a device, a specification, a batch record and a label. A vial sold under the code name shares the chemistry and none of the rest.

Why that distinction is the whole article: the approval is the paperwork, not the peptide. Strip the paperwork and what is left is an unapproved substance with a familiar name.

Is bremelanotide approved for men?

No. The label's Limitations of Use say the product is not indicated for HSDD in postmenopausal women or in men, and is not indicated to enhance sexual performance. That is the approved text, printed in section 1.

The irony in the history: the original clinical program was in men with erectile dysfunction, and it did not produce an approval. The approval that eventually arrived excluded them by name.

Is PT-141 legal to buy?

In the United States bremelanotide is a prescription drug. The approved product carries the "Rx only" legend on its label, and a drug that requires a prescription is not lawfully sold over a counter or a checkout page, whatever the listing calls it.

The approved product is not the only lawful pathway: section 503A of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 353a, exempts a compounded drug product from three parts of the statute when it is compounded for an identified individual patient on a valid prescription order by a licensed pharmacist or licensed physician, and when the rest of that section's requirements are met. That is a conditional route, and it is still a prescription route. It is not a route to a checkout page.

Correction, 29 July 2026: an earlier version of this page said we had found no warning letter naming bremelanotide. That was wrong. FDA wrote to Tailor Made Compounding LLC on 1 April 2020 listing "Bremelanotide (PT-141)" among the substances the firm compounded with, and to Promise Pharmacy LLC on 29 July 2019 over an injectable bremelanotide product measured at 114.3 percent of the amount stated on its label. Both letters were retrieved and read on 29 July 2026, HTTP 200.

Is bremelanotide on the WADA Prohibited List?

Not by name. Three search terms, bremelanotide, PT-141 and melanocortin, return nothing in the official text of the 2026 Prohibited List. That is a finding about the printed names only: the list's category definitions reach substances it does not spell out, so an athlete's own anti-doping organization is the body that can answer the question this heading asks.

Why the answer is a verified negative: the compound is approved for human therapeutic use, so the S0 non-approved substances class, which covers drugs with no current approval by any governmental regulatory health authority, does not apply to it on its face.

What the approved record leaves unanswered

Four gaps, three of them printed on the label itself:

Duration of effect. The approved label states it is unknown and that the optimal window has not been fully characterized.
Mechanism. The approved label states in section 12.1 that the mechanism by which the product improves HSDD in women is unknown.
Pregnancy. The label states the pregnancies observed in trials were too few to determine risk, and that animal reproduction work reported fetal harm at exposures at least 16 times the highest exposure the label allows, measured by area under the curve.
Anything outside the label population. The phase 3 program enrolled premenopausal women aged 19 to 56. No other group has an equivalent published dataset.

The safety picture, from the label

What the approved text reports: nausea in 40 percent of treated patients, needing anti-emetic therapy in 13 percent and ending participation for 8 percent; flushing in 20.3 percent; injection site reactions in 13.2 percent; headache in 11.3 percent. A transient blood pressure rise and heart rate drop after each dose, with the product contraindicated in uncontrolled hypertension or known cardiovascular disease. Focal hyperpigmentation of face, gums and breasts, more likely in people with darker skin, and not confirmed to resolve in everyone after stopping. Overall, 18 percent of treated patients discontinued for adverse reactions against 2 percent on placebo. Whether any of that applies to one person is a question for a prescriber with their history.

How this page is sourced

The label is the spine: every section number and figure quoted above was read in the approved prescribing information itself, revised March 2024, not in a summary of it. The trial figures come from the published phase 3 report.

Ten sources: one approved label, one agency approval letter, two agency warning letters, one section of the United States Code, one international standard checked for a negative, and four papers with DOIs and PubMed IDs.

The standard: the full sourcing and citation-verification standard for this site, including who checks a page before it ships, lives on the methodology page.

Last reviewed: 29 July 2026.

1
VYLEESI (bremelanotide injection), for subcutaneous use. Full prescribing information, initial U.S. approval 2019, revised 3/2024, labeler Cosette Pharmaceuticals, Inc. Sections 1, 2.1, 3, 4, 5.1, 5.2, 5.3, 6.1, 8.1, 12.1 and 14. This page previously cited the 2/2021 revision under an earlier set id; every figure quoted above was re-read in the current label on 31 July 2026 and each one still appears there unchanged, including the 18 percent against 2 percent discontinuation rate, which the current label prints in section 6.1. DailyMed SPL published 18 November 2025, retrieved 31 July 2026, HTTP 200. DailyMed, VYLEESI prescribing information, set id f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf.
2
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. NDA 210557 approval letter, Vyleesi (bremelanotide) subcutaneous injection, electronically signed 21 June 2019. Accessed 29 July 2026. accessdata.fda.gov, NDA 210557 approval letter.
3
Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials. Obstet Gynecol. 2019;134(5):899-908. doi:10.1097/AOG.0000000000003500. PMID 31599840.
4
Molinoff PB, Shadiack AM, Earle D, Diamond LE, Quon CY. PT-141: a melanocortin agonist for the treatment of sexual dysfunction. Ann N Y Acad Sci. 2003;994:96-102. doi:10.1111/j.1749-6632.2003.tb03167.x. PMID 12851303.
5
Diamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB. 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;16(1):51-59. doi:10.1038/sj.ijir.3901139. PMID 14963471.
6
Rosen RC, Diamond LE, Earle DC, Shadiack AM, Molinoff PB. 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;16(2):135-142. doi:10.1038/sj.ijir.3901200. PMID 14999221.
7
World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026, searched for bremelanotide, PT-141 and melanocortin with no match; section S0 read for scope. Effective 1 January 2026. Accessed 27 July 2026. Re-checked 31 July 2026: an automated request for the list PDF returned HTTP 202 with an empty body, which is a bot challenge rather than a missing document, so this source could not be re-retrieved by script on that date. wada-ama.org, 2026 Prohibited List.
8
U.S. Food and Drug Administration. Warning letter to Tailor Made Compounding LLC, reference 594743, 1 April 2020, naming "Bremelanotide (PT-141)" in a list of substances the firm compounded drug products with, in a discussion of the conditions of section 503A. Retrieved 29 July 2026, HTTP 200. fda.gov warning letter 594743.
9
U.S. Food and Drug Administration. Warning letter to Promise Pharmacy, LLC, reference 587148, 29 July 2019, reporting that a distributed injectable bremelanotide product was determined to have 114.3 percent of the amount of bremelanotide stated on its label. Retrieved 29 July 2026, HTTP 200. fda.gov warning letter 587148.
10
United States Code, title 21, section 353a, Pharmacy compounding, 2023 edition, subsection (a), read for the conditions under which sections 351(a)(2)(B), 352(f)(1) and 355 do not apply to a compounded drug product. Retrieved 29 July 2026, HTTP 200. govinfo.gov, 21 U.S.C. 353a.

Around this page: five neighboring pages on classification, on labels, and on what a vial can be shown to hold.

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Is ostarine a steroid: what happens when a drug reaches phase 2 and stops, in statutory terms.
What a lyophilized peptide is: why an approved injectable arrives as a solution here and as a powder elsewhere.
How to read a COA: the document that stands in for a specification when there is no approved product.
What a syringe unit is: the arithmetic layer, for the pages where the numbers do the work.

One label a week: the approved text, pulled apart and posted to The Decadewise briefing.

The disclaimer

Every page is reviewed by medical professionals before it ships, and written with longtime biohackers who were doing this before it was a trend. Reviewed still does not mean prescribed: nothing here is medical advice. It is research, trial data, and reported use, with the numbers intact so you can check them. For decisions about your body, see a doctor who can look at your labs.