Bremelanotide (PT-141): Identity, Evidence, and FDA Status

Reviewed on: August 27, 2026.

This page summarizes published research and official regulatory records. It does not provide medical advice or instructions for using any substance. A laboratory catalog material is not an FDA-approved drug and is not represented here as suitable for human or veterinary use.

Evidence state at a glance

Bremelanotide has direct receptor studies, animal research, and randomized human trials. The FDA-approved finished drug Vyleesi contains bremelanotide, but that approval is product-specific. It does not transfer to a laboratory material that shares the names bremelanotide or PT-141.

What are bremelanotide, PT-141, and Vyleesi?

PT-141 is the development name commonly associated with bremelanotide. Vyleesi is the brand name of a particular FDA-approved finished drug containing bremelanotide. These names overlap, but they are not interchangeable product-quality or regulatory claims.

The current Vyleesi label describes its active ingredient as bremelanotide acetate, a synthetic cyclic heptapeptide with an acetylated amino terminus and a free-acid carboxyl terminus. The label identifies it as a nonselective melanocortin-receptor agonist and states that the mechanism by which the approved drug improves the relevant symptoms is unknown.[1]

An approved finished drug is evaluated as a complete product, including its active ingredient, formulation, manufacturing controls, container system, and labeling. A catalog item named PT-141 or bremelanotide is not Vyleesi, a generic Vyleesi product, or clinically equivalent merely because the names appear similar. A meaningful identity comparison would require the complete sequence, stereochemistry, ring closure, terminal groups, counterion, molecular mass, impurity profile, and lot-level analytical record.

In-vitro evidence: receptor structure and signaling

A 2021 primary study resolved bremelanotide in a complex with the human melanocortin-4 receptor and paired structural work with cell-based signaling assays. The study helps explain how the peptide can be recognized by and activate this receptor.[4] It does not measure sexual desire, distress, cardiovascular outcomes, or any other patient-centered endpoint. It also does not establish that an independently manufactured catalog material has the identity or activity of the study material.

This distinction matters because receptor activation in an engineered cell system is mechanistic evidence. It is not, by itself, evidence of clinical effectiveness, safety, or product equivalence.

Animal evidence: selected behaviors changed, others did not

In ovariectomized, hormone-primed female rats, PT-141 altered selected solicitation and appetitive-behavior measures. The same experiment reported no change in lordosis, pacing, general locomotor activation, or conditioned sexual reward.[5] Those null findings are part of the result, not secondary details to omit.

The model uses species-specific behaviors under controlled hormonal conditions. It cannot reproduce human diagnostic criteria, distress, relationships, or quality of life. The paper also reported support from the compound’s developer and stock ownership by two authors, which should be considered when interpreting the findings.[5]

Observational-human evidence

No eligible observational-human study was included in this review. Open-label follow-up and postmarketing reports may contribute to safety surveillance, but they are not controlled effectiveness evidence and are not used here to expand the findings from randomized trials.

Interventional-human evidence

The strongest direct human evidence comes from the two RECONNECT Phase 3 trials, NCT02333071 and NCT02338960. These randomized, double-blind, placebo-controlled studies enrolled premenopausal women with acquired, generalized hypoactive sexual desire disorder. The pooled publication reported larger changes with bremelanotide than with placebo on the coprimary measures of sexual desire and distress related to low desire.[6]

The same report found no statistically significant between-group difference in the number of satisfying sexual events associated with study-drug use during the prespecified window.[6] That null endpoint is especially important because a broad statement that the trials improved every meaningful sexual outcome would be inaccurate.

An earlier randomized Phase 2 study evaluated bremelanotide in the same broad research area. Selected desire, distress, and event measures favored some study groups, but the work was a limited-duration development study with multiple outcomes and sponsor involvement.[7] A separate controlled study characterized transient blood-pressure increases and heart-rate reductions after bremelanotide exposure.[8] That study informs physiological safety characterization; it is not evidence of clinical benefit.

The current Vyleesi label summarizes clinically important risks observed in the development program, including transient blood-pressure and heart-rate effects, focal hyperpigmentation, and nausea.[1] Those label findings belong in an evidence review, but they should not be converted into self-use instructions.

Negative and null findings

The evidence does not support a uniformly positive account.

• The pivotal pooled report did not find a significant improvement over placebo in the prespecified satisfying-sexual-event measure associated with study-drug use.[6]
• The FDA review described the pivotal changes as statistically significant but modest; approval should not be rewritten as a dramatic or universal effect.[3]
• The approved label states that the mechanism responsible for improvement in the labeled symptoms is unknown.[1]
• Several behavioral outcomes in the rat study did not change.[5]
• Controlled cardiovascular research documented transient physiological changes rather than a benefit outcome.[8]
• No cited study shows that the clinical material is identical to a Serum Research catalog lot.

Current U.S. FDA status

Status checked August 27, 2026: FDA approved the finished Vyleesi drug under NDA 210557 in 2019.[2] Its current label defines a narrow indication in premenopausal women with acquired, generalized hypoactive sexual desire disorder that meets the label’s criteria. The label states that Vyleesi is not indicated for postmenopausal women, men, or enhancement of sexual performance.[1]

That approval is specific to Vyleesi. It does not approve bulk bremelanotide, a lyophilized laboratory vial, a compounded preparation, or any other material merely called PT-141 or bremelanotide. Serum Research catalog material must not be described as Vyleesi, generic Vyleesi, FDA approved, or clinically interchangeable with the approved drug.

What the evidence cannot establish

The randomized trials apply to their defined participants, endpoints, study periods, and finished clinical materials. The pivotal population was predominantly White and U.S.-based, and much of the development evidence was industry funded. These features limit generalization and should remain visible beside the findings.

Neither an FDA approval nor a published paper authenticates a third-party catalog vial. A shared name does not demonstrate the same molecular form, purity, impurities, formulation, stability, or manufacturing controls. This page therefore makes no claim that Serum Research catalog material reproduces the identity, performance, safety profile, or regulatory status of Vyleesi or any trial material.

Frequently asked questions

Is PT-141 another name for bremelanotide?

PT-141 is the development name commonly used for bremelanotide. The name relationship does not prove that two commercial materials share the same molecular form, formulation, purity, or quality.

Is a catalog PT-141 vial the same as Vyleesi?

No. Vyleesi is a specific FDA-approved finished prescription drug reviewed under NDA 210557. A catalog research material is not Vyleesi and does not inherit its approval, label, formulation, or clinical evidence.

Is bremelanotide FDA approved?

The finished Vyleesi drug is FDA approved for the population and indication defined in its label. That statement must not be broadened to other products or uses.

What did the pivotal trials find?

The pooled trials reported statistically significant differences from placebo on measures of desire and related distress. They did not find a statistically significant difference in the prespecified satisfying-sexual-event measure associated with study-drug use.

Does this page explain how to use bremelanotide?

No. This is an identity, evidence, and regulatory-status summary. It intentionally provides no preparation, administration, or self-use instructions.

Primary and official sources

1. DailyMed. Current Vyleesi prescribing information, set ID f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf. Official label
2. U.S. Food and Drug Administration. Vyleesi approval letter, NDA 210557, 2019. FDA approval letter
3. U.S. Food and Drug Administration. NDA 210557 multidisciplinary review. FDA review
4. Yu J, et al. Structural and signaling study of melanocortin receptors, 2021. PMID 34433901 · PMCID PMC8563965 · DOI 10.1038/s41422-021-00552-3
5. Pfaus JG, et al. PT-141 in a female-rat behavioral model, 2004. PMID 15226502 · PMCID PMC454387 · DOI 10.1073/pnas.0400491101
6. Kingsberg SA, et al. RECONNECT Phase 3 trials, 2019. PMID 31599840 · PMCID PMC6819021 · DOI 10.1097/AOG.0000000000003500 · NCT02333071 · NCT02338960
7. Clayton AH, et al. Randomized Phase 2 trial, 2016. PMID 27181790 · PMCID PMC5384512 · DOI 10.2217/whe-2016-0018 · NCT01382719
8. White WB, et al. Ambulatory cardiovascular-physiology study, 2017. PMID 27977473 · PMCID PMC5338879 · DOI 10.1097/HJH.0000000000001221