Bremelanotide / PT-141

Human evidence can mean a controlled clinical study, an observational study, a safety or exposure report, or evidence from a particular finished formulation. Those are different kinds of information.

Human evidence in specific contexts. Human studies are available in defined contexts, but the evidence remains product-, population-, route-, or outcome-specific.

Preclinical means research in cells, tissues, or animals rather than in people. It can help researchers form a hypothesis, but it cannot establish a human benefit or a complete human safety profile.

Nonclinical melanocortin-receptor pharmacology and toxicology supported development. These findings do not establish outcomes in populations outside the label.[1]

Preclinical findings do not establish outcomes in people.

Risk information may describe the compound, a finished product, a route, a population, or product-quality concerns. The cited material does not replace a current product label or an individual professional assessment.

This section is about the United States only. Status applies to a product, formulation, route, population, and use—not to a name in the abstract. A status shown here is not a recommendation or a statement about another country.

• Source/status dateNov 18, 2025

  FDA-approved medicine

  Bremelanotide is FDA approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women under the full labeled criteria and limitations.

  Specific product form or route is not separately published in this status record.

  Open source context

The date above is the date attached to the published status record or source context. It is not necessarily the original approval date.

These prompts help organise a conversation with a qualified professional. They do not create a treatment recommendation, dose, or protocol.

• EvidenceWhich human evidence applies to the exact product, form, route, and use being discussed?
• What remains uncertainWhat is known, and what remains uncertain for this specific context?
• RisksWhich important warnings, common effects, and product-quality concerns should be discussed?
• U.S. statusWhat does the U.S. status cover, and what does it not cover?

Related means that the profiles share a topic, pathway, product context, or research question. It does not mean that they are equivalent.

• EstradiolBoth may appear in sexual-health research, but their mechanisms and labeled populations differ.

PeptideGrid review date: Jul 22, 2026. Sources support the specific sections that cite them. Publication does not imply endorsement, equivalence, or individual suitability.

1. 1

   VYLEESI prescribing information

   DailyMed. VYLEESI (bremelanotide) prescribing information. Revised November 2025.

   National Library of Medicine / Cosette Pharmaceuticals · Published Nov 18, 2025 · Accessed Jul 22, 2026 · Prescribing information

   Open source