Bremelanotide (PT-141)
How did an analogue developed for pigmentation lead research towards the central circuits of desire? Bremelanotide arose from an unexpected observation that became a full clinical programme.
- Research Use Only
- Molecule under study
- Living document
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- Current research state
- An FDA-approved molecule (Vyleesi®) for a specific indication; not approved by the EMA. PHL presents it as Research Use Only.
- Current clinical phase
- FDA approval (female HSDD) — earlier development for erectile dysfunction discontinued
- Last update
- 21 July 2026 · Reference fact sheet v1.0
- Living document
- Updated regularly as research progresses.
What is Bremelanotide (PT-141)?
Bremelanotide, known in research by the code PT-141, is a cyclic peptide of 7 amino acids and a synthetic analogue of α-MSH (α-Melanocyte Stimulating Hormone).
It is derived from Melanotan-II (MT-II): researchers sought a molecule that retained the observed effect on sexual desire without inducing the systemic pigmentation caused by MT-II.
After development for erectile dysfunction was discontinued for tolerability reasons (hypertension at high intranasal doses), it was successfully repositioned for female hypoactive sexual desire disorder, leading to FDA approval in 2019.
Names you may come across
This molecule may appear under several names in the scientific, clinical or technical literature. Here are the main designations you may come across.
International nonproprietary name (INN).
Development code widely used in the research literature.
Brand name of the medicinal product approved by the FDA in 2019.
Understanding it simply
Three simple reference points for understanding PT-141.
Action in the brain
Unlike erection treatments that act on blood vessels, PT-141 acts on the brain circuits of desire. It is therefore not a “Viagra equivalent”.
A derivative of Melanotan-II
PT-141 was designed from Melanotan-II with the aim of retaining the effect on sexual desire without causing systemic pigmentation.
A targeted approval
It is approved in the United States for a specific indication (hypoactive sexual desire disorder in premenopausal women), not as a universal “desire pill”.
What research shows today
Science advances step by step. We clearly distinguish what is firmly established from what remains under study.
- A cyclic heptapeptide derived from Melanotan-II, with the sequence Ac-Nle-cyclo(Asp-His-D-Phe-Arg-Trp-Lys)-OH. — established
- An agonist of the melanocortin receptors MC1R, MC3R, MC4R and MC5R, with a functional preference for MC4R in the central nervous system. — established
- A central (CNS) mechanism of action on the neural circuits of sexual desire — independent of the vascular mechanisms of erectile dysfunction. — established
- Demonstrated efficacy in hypoactive sexual desire disorder in premenopausal women (RECONNECT trials). — established
- Optimal positioning in other indications (male erectile dysfunction) was not pursued in clinical development. — ongoing
Published randomized phase 3 clinical trials (RECONNECT studies) in female hypoactive sexual desire disorder, which led to FDA approval in 2019 under the name Vyleesi®. No general approval beyond this indication.
What the research shows
- Well-characterized melanocortin pharmacology: MC1R/MC3R/MC4R/MC5R agonism with a functional preference for MC4R.
- A central mechanism affecting sexual desire demonstrated in preclinical models and clinical studies.
- RECONNECT trials (two randomized, placebo-controlled phase 3 trials) demonstrating a significant improvement in desire and associated distress in premenopausal women with HSDD.
- FDA approval in June 2019 on this basis.
What still remains to be studied
- Response varies between individuals — predictors of a good response remain to be defined.
- Clinical positioning relative to flibanserin (another HSDD medicine).
- Long-term effects of repeated use are poorly documented beyond the pivotal trials.
What we know today
Not all information carries the same weight of evidence. We therefore present it across three clearly distinct levels, from the most solid to the most indicative.
What scientific publications show
Scientific evidence- Publications converge on a central mechanism involving the melanocortin axis, distinct from vascular mechanisms.
- The RECONNECT trials demonstrated a statistically significant improvement on validated scales of sexual desire (FSFI) and distress (FSDS-DAO).
- The predominant tolerability profile is characterized by nausea, flushing and headache.
What some professionals report
Documented- US clinicians emphasize that it is an adjunctive treatment to be integrated into comprehensive management of desire disorders.
- European guidelines do not yet define its place in treatment, in the absence of EMA approval.
What the community reports
Field observations- Community reports often describe marked subjective effects on libido and a high rate of nausea.
- Individual observations do not replace clinical trials or medical recommendations.
The evidence is strong for the FDA-approved indication; it is weaker for all other reported uses.
How does Bremelanotide (PT-141) work?
PT-141 acts on melanocortin receptors, a family of receptors involved in several physiological functions, including sexual function.
- Melanocortin receptors (MC1R–MC5R)
- G protein-coupled receptors, of which MC4R is predominantly expressed in the central nervous system.
- Hypothalamus (paraventricular nucleus)
- Activation of the neural circuits of sexual desire via MC4R, independently of peripheral vascular pathways.
- Limbic system
- Modulation of the motivational and emotional components of desire.
- Vascular system
- An adverse effect involving a transient increase in blood pressure (the reason for the contraindication in uncontrolled hypertension).
Its action is central, which fundamentally distinguishes PT-141 from PDE5 inhibitors (sildenafil and related agents), which act peripherally on the vasculature.
Clinical trials timeline
A molecule under study progresses step by step. Here, simply, is where the research currently stands.
- Discovery· 1990sCompleted
Development from Melanotan-II
Palatin Technologies develops MT-II analogues to separate the effect on sexual desire from pigmentation.
- Phase 1-2· 2000sCompleted
Trials in erectile dysfunction
Intranasal development discontinued because of blood pressure elevations at high doses.
- Repurposing· Late 2000sCompleted
Female desire disorder (HSDD)
Clinical development is redirected toward female HSDD, with on-demand subcutaneous administration.
- Phase 3· 2016-2017Completed
RECONNECT studies
Two randomized, placebo-controlled trials demonstrate efficacy and tolerability in premenopausal women with HSDD.
- Approval· 2019Completed
FDA approval (Vyleesi®)
The FDA approves bremelanotide for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
Available analyses
No analytical document has been published for this molecule to date.
Open the analysis libraryFrequently asked questions
Is PT-141 an approved medicine?
Established: yes, in the United States (Vyleesi®, FDA approval in 2019) for a specific indication (HSDD in premenopausal women). It is not approved in Europe. PHL presents it as Research Use Only.
Is it a Viagra equivalent?
Established: no. Viagra® (sildenafil) acts peripherally on the vasculature. PT-141 acts centrally on the circuits of desire. The mechanisms and indications differ.
Does it work in men?
To be investigated: initial trials explored this possibility, but clinical development in men was discontinued. Current data primarily concern premenopausal women.
Does it cause pigmentation like Melanotan-II?
Established: the effect is much smaller because PT-141 was specifically designed to minimize it, with on-demand administration. Focal pigmentation has been reported with repeated use.
What adverse effects have been reported?
Established: nausea (common), flushing, headache and a transient rise in blood pressure. This is why it is contraindicated in uncontrolled hypertension.
Can it be combined with other treatments for sexual dysfunction?
To be investigated: combinations must be assessed by a healthcare professional. Clinical data on combination use are limited.
Scientific publications
A selection of reference publications on bremelanotide / PT-141 — melanocortin pharmacology, phase 3 RECONNECT trials and FDA approval. An evolving bibliography.
The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women
Pfaus J. et al. · CNS Spectrums · 2007
Glossary
- α-MSH
- α-Melanocyte Stimulating Hormone — a POMC-derived hormone and a natural agonist of melanocortin receptors.
- Melanocortin receptors (MCR)
- A family of 5 receptors (MC1R–MC5R) involved in pigmentation, energy balance, inflammation and sexual function.
- MC4R
- Melanocortin receptor type 4, primarily expressed in the central nervous system and involved in sexual desire and appetite.
- HSDD
- Hypoactive Sexual Desire Disorder — a clinical entity defined in psychiatric classifications.
- Melanotan-II
- An α-MSH analogue from which bremelanotide is derived, initially studied for pigmentation.
- FDA
- U.S. Food and Drug Administration — the US medicines regulatory agency.
Continue your discovery
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Reference fact sheet — version 1.0, updated on 21 July 2026. The full regulatory and scientific framework is gathered in the “Important information” box at the top of the fact sheet.