melanocortin receptor agonist
Bremelanotide
Answer
Bremelanotide is authorised or registered in the US: 1 of the 10 registers read. Highest trial phase: Phase 2. It has 10 registered trials, 1 of them running. Brand names on the FDA label register: Vyleesi.
RegulatorTrial register10 regulators' registers, read 2026-08-31 to 2026-10-03 · ClinicalTrials.gov, read 2026-10-03
Not medical, legal or regulatory advice.
10 trials by status
Trial registerClinicalTrials.gov · read 2026-10-03 · 4 trials have posted results
Trials first submitted per year
Trial registerClinicalTrials.gov first-submitted date, last 8 years · read 2026-10-03.
Status by jurisdiction
World map| Where | Status | Register | Read |
|---|---|---|---|
| United States | FDA-approved | FDA, openfda | 2026-10-03 |
| European Union | Not on the register | EMA, ema | 2026-08-31 |
| United Kingdom | Not on the register | MHRA, uk-mhra | 2026-09-03 |
| Canada | Not on the register | Health Canada, ca-dpd | 2026-09-03 |
| Australia | Status unknown | TGA, au-artg | not read |
| Switzerland | Not on the register | Swissmedic, ch-swissmedic | 2026-09-03 |
| Brazil | Not on the register | ANVISA, br-anvisa | 2026-09-03 |
| Serbia | Not on the register | ALIMS, rs-alims | 2026-09-03 |
| Singapore | Not on the register | HSA, sg-hsa | 2026-09-03 |
| Turkey | Not on the register | TITCK, tr-titck | 2026-09-03 |
An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.
Side effects
Trial registerCHANGE ALERTS
Get an email when this changes
One email when the status of Bremelanotide changes on the register. You confirm your address first.
ENFORCEMENT AND OFFICIAL ACTIONS
1 action by named authorities
Enforcement actions, board positions and payer rules that name Bremelanotide, quoted from the source document. These are not approval decisions. This list shows the actions found so far. It is not a complete list: no authority publishes one.
| US-CAenforcement | California Board of Pharmacy, 2023-12-04 Respondent maintains a YouTube.com channel/account, on which it posts videos advertising its products. On or about November 21, 2018, a pharmacist employed by Respondent gave a presentation about CJC-1295, Ipamorelin, PT-141, Bremelanotide, and BPC-157. Respondent posted this presentation to its YouTube.com channel. In this presentation, Respondent promotes the referenced drugs as being safe for use in humans and useful for a number of conditions and performing a number of functions, none of which have been proven by any scientific studies.California Board of Pharmacy, First Amended Accusation and First Amended Statement of Issues, Case Nos. 7160 and 7171, paragraph 54 |
|---|
REGISTERED TRIALS
10 trials, newest first
| NCT06867835 | Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk completed · register updated 2026-01-13 |
|---|---|
| NCT06565611 | A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity running, but no longer enrolling · register updated 2025-03-06 |
| NCT04943068 | A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and completed · register updated 2024-11-13 |
| NCT05709444 | A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease completed · register updated 2024-10-17 |
| NCT04179734 | Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder completed · register updated 2024-08-09 |
| NCT03973047 | Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With completed · register updated 2022-04-04 |
| NCT02333071 | 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder completed · register updated 2021-04-09 |
| NCT02338960 | 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder completed · register updated 2021-01-28 |
| NCT01382719 | Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder completed · register updated 2014-12-18 |
| NCT00425256 | Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) completed · register updated 2011-02-23 |
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New trials, approvals and enforcement actions. One email a week.