What Is PT-141 (Bremelanotide) Used For? Approved Uses, Per the Label

PT-141 is the development code for bremelanotide, a prescription medicine approved in the United States. It is a melanocortin receptor agonist peptide supplied as a single use autoinjector and marketed under the brand name Vyleesi. This page describes only what the current US prescribing information lists as an approved use, the trial program behind that approval, and the regulatory history of the indication. This page is for educational purposes only and is not medical advice; consult a licensed physician or other qualified clinician about any personal health question, including whether a prescription medicine is appropriate.

The short answer: one approved indication

The US label for bremelanotide injection carries a single indication. It describes the product as indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Hypoactive sexual desire disorder is defined in the labeling as low sexual desire that causes marked distress or interpersonal difficulty and that is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.

The label narrows that definition further with two qualifiers that appear in the indication itself:

• Acquired, meaning the low desire developed in a person who previously had no problem with sexual desire.
• Generalized, meaning the low desire is not limited to certain types of stimulation, situations, or partners.

Those two words are part of the indication, not commentary on it. A person whose low desire has been lifelong, or whose low desire occurs only in specific situations, falls outside the wording of the approved indication as written.

Limitations of use stated in the label

The prescribing information includes a limitations of use section. As worded there, bremelanotide is not indicated for the treatment of HSDD in postmenopausal women or in men, and it is not indicated to enhance sexual performance. These statements sit directly under the indication in the label and are part of how the approved use is defined.

US label versions on DailyMed: Vyleesi (bremelanotide) injection, prescribing information revised March 2024 (DailyMed). The current label for the specific product governs.

Regulatory history of the indication

Bremelanotide was first developed under the code PT-141 by Palatin Technologies, which studied the peptide as a melanocortin receptor agonist for sexual dysfunction. An earlier intranasal formulation was evaluated in clinical development before the program moved to a subcutaneous autoinjector presentation, which is the form that reached the US market.

The US Food and Drug Administration approved bremelanotide injection in June 2019 for acquired, generalized hypoactive sexual desire disorder in premenopausal women. The product was launched in the United States by AMAG Pharmaceuticals under a licence from Palatin Technologies, and US commercial rights were later transferred to Cosette Pharmaceuticals. The indication itself has not been broadened since approval: the label still carries the same single indication and the same limitations of use. Availability and approval status outside the United States are set by each national or regional regulator and differ from the US position.

A second approved product in the same therapeutic space, flibanserin, is a daily oral medicine rather than a peptide, and it carries its own separately worded indication. The existence of a second approved option for HSDD does not change the wording of the bremelanotide indication, and the two products are not interchangeable in label terms.

The pivotal trial program behind the indication

Approval rested on two identically designed phase 3 studies in premenopausal women with acquired, generalized HSDD, known in the program as the RECONNECT studies. Both were randomized, double blind and placebo controlled, with a core treatment period followed by an open label extension. The co-primary endpoints were change in the desire domain of the Female Sexual Function Index and change in the item of the Female Sexual Distress Scale that measures distress about low sexual desire.

Quantitative results from those two trials are reported in the prescribing information and in the published trial reports. This page does not restate effect sizes, response rates, or dosing figures, because those numbers are outside the scope of the sources cited below. A prescribing clinician has direct access to the full label and can explain what the trial results mean for a specific person.

How the mechanism has been described in the literature

Bremelanotide acts at melanocortin receptors rather than on the vascular pathways targeted by phosphodiesterase type 5 inhibitors. Preclinical work supported interest in that pathway for sexual behaviour: in a 2004 study in the Proceedings of the National Academy of Sciences, researchers reported that a melanocortin receptor agonist selectively facilitated sexual solicitation behaviour in female rats, an effect the authors distinguished from general changes in locomotor activity (PMID 15226502). That animal work describes a behavioural mechanism in rodents and does not establish a human use; the human use is defined by the label.

Interest in centrally acting agents for sexual dysfunction predates the approval. A 2003 German language review of erectile dysfunction therapy surveyed the treatment landscape and the agents then under development alongside established options (PMID 14569381). More recently, a 2025 narrative review in Expert Opinion on Pharmacotherapy examined peptide and amino acid based approaches studied for erectile dysfunction and outlined future research directions in that field (PMID 40069591). Reviews of this kind map a research field; they do not create or extend an approved indication.

Bremelanotide also appears in broader surveys of therapeutic peptides. A 2026 review in the International Journal of Molecular Sciences covered therapeutic peptides used in aesthetic, metabolic and endocrine conditions and discussed their effects, safety considerations, clinical applications and future perspectives (PMID 42123471). That review situates approved peptide medicines within a much larger group of peptides, most of which have no approved indication at all.

A short note on uses that are not approved

Material labelled PT-141 also circulates outside the regulated prescription supply chain, including compounded preparations, and it is sometimes discussed in connection with sexual function in men. None of those are approved uses. The only indication in the US prescribing information is the one stated above. Compounded preparations are not FDA approved products and have not undergone the review that produced the labeled indication. Reviews that discuss peptides in the context of erectile dysfunction describe an area of investigation rather than an approved use (PMID 40069591).

Adverse Events: What Studies Report

The adverse reactions section of the US prescribing information for bremelanotide lists nausea as the most frequently reported adverse reaction in the phase 3 trials, along with flushing, injection site reactions, headache and vomiting. The label also describes transient increases in blood pressure with decreases in heart rate after administration, which is why the labeling addresses use in people with cardiovascular disease and uncontrolled hypertension. Focal darkening of the skin, gums or face has also been described in the labeling. These are label facts drawn from the trial safety database rather than independent findings restated from the sources cited on this page.

Broader peptide literature has also addressed safety as a general theme: the 2026 International Journal of Molecular Sciences review examined the effects, safety and clinical applications of therapeutic peptides across several condition areas (PMID 42123471), and the 2025 narrative review of peptides studied for erectile dysfunction likewise discussed current applications alongside their limitations (PMID 40069591). In the rodent literature, the study of melanocortin agonism in female rats reported behavioural effects rather than a clinical safety profile (PMID 15226502). A clinician with access to a full medical history is the appropriate person to weigh warnings, contraindications and interactions for an individual.

Reading the label question accurately

Three distinctions make the approved use easier to interpret:

1. Indication versus mechanism. Melanocortin receptor activity explains how the peptide is thought to act; it does not define what the product is approved to treat.
2. Indication versus research interest. Published reviews of peptides in sexual medicine describe ongoing investigation (PMID 14569381), and investigation is not approval.
3. Product versus substance. The approved indication attaches to a specific FDA approved injection product with a specific label, not to any material bearing the name PT-141.

Questions a prescribing clinician can answer

• Whether a given pattern of low sexual desire meets the acquired and generalized criteria in the indication.
• Whether another medical condition, medication or relationship factor better explains the symptom.
• How the warnings, contraindications and interactions in the current label apply to a particular medical history.
• What the trial endpoints measured and what size of change was observed in the pivotal studies.
• What monitoring, if any, the label describes.

Further background on the peptide, including its development history and the research literature, is collected on the PT-141 learn page.

References

• Selective facilitation of sexual solicitation in the female rat by a melanocortin receptor agonist (Proceedings of the National Academy of Sciences of the United States of America, 2004)
• [Therapy of erectile dysfunction in 2005] (Der Urologe. Ausg. A, 2003)
• Intravenous peptides and amino acids for erectile dysfunction: a narrative review of current applications and future directions (Expert Opinion on Pharmacotherapy, 2025)
• Therapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives (International Journal of Molecular Sciences, 2026)