At a glance
- Bremelanotide (PT-141) is an FDA-approved drug, marketed as Vyleesi (first approval: June 21, 2019).
- PubMed lists 113 publications mentioning it, including 14 randomized controlled trials and 7 animal-only studies.
- ClinicalTrials.gov lists 10 registered studies testing it (1 active).
- FDA's adverse event system (FAERS) holds 1,005 reports mentioning it; 31 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA210557 | VYLEESI (AUTOINJECTOR) | Approved, marketed | June 21, 2019 | COSETTE |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Peptides in urology and sexual medicine: clinical effectiveness, dosing, indications, and safety: a narrative review.
- Comprehensive characterization of bremelanotide acetate and its degradants by LC-HRMS/MS and predicting epimerization through computational modelling.
- Goldilocks-Inspired Design of Mid-Size Macrocycles for Selective Targeting of Human Melanocortin Receptors.
- Clinical trial evidence on emerging pharmacological therapies for hypoactive sexual desire disorder in women: a systematic review and analysis of completed studies registered on ClinicalTrials.gov.
- Quantification of "Mercy Sex" in Heterosexual Women.
- Therapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives.
- FDA-Approved Drugs Containing D-Amino Acids: A Historical and Developmental Perspective.
- Therapeutic peptides in gerontology: mechanisms and applications for healthy aging.
- Should Bremelanotide Be Considered for the Treatment of Sexual Arousal and Desire Disorders in Men?
- Strategies for Treating Sexual Health Concerns After Breast and Gynecologic Cancer.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 10
- Active
- 1
- With posted results
- 4
Conditions studied
All 10 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 1,005
- Serious
- 31
- With death outcome
- 1
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.