| 2025-11-13 | Label | FDA label revised: Vyleesi (NDA210557) | Regulator FDA drug label register |
| 2025-03-10 | Trial | New trial registered: Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk | Trial register ClinicalTrials.gov |
| 2024-08-22 | Trial | New trial registered: A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity | Trial register ClinicalTrials.gov |
| 2024-08-09 | Results | Results posted: Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder | Trial register ClinicalTrials.gov |
| 2023-12-04 | Action | California Board of Pharmacy: board | Regulator California Board of Pharmacy |
| 2023-02-02 | Trial | New trial registered: A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease | Trial register ClinicalTrials.gov |
| 2022-04-27 | Recall | FDA recall, Class II: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Lack of Assurance of Sterility: deviations from Current Good Manu | Regulator FDA enforcement reports |
| 2021-06-29 | Trial | New trial registered: A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutan | Trial register ClinicalTrials.gov |
| 2021-03-25 | Federal Register | Federal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | Regulator Federal Register |
| 2021-01-28 | Results | Results posted: 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder | Trial register ClinicalTrials.gov |
| 2020-12-23 | Results | Results posted: 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder | Trial register ClinicalTrials.gov |
| 2020-08-20 | Federal Register | Federal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; VYLEESI | Regulator Federal Register |
| 2019-11-27 | Trial | New trial registered: Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder | Trial register ClinicalTrials.gov |
| 2019-06-04 | Trial | New trial registered: Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran | Trial register ClinicalTrials.gov |
| 2019-02-20 | Recall | FDA recall, Class II: Promise Pharmacy, LLC. Lack of sterility assurance. | Regulator FDA enforcement reports |
| 2015-01-15 | Trial | New trial registered: 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder | Trial register ClinicalTrials.gov |
| 2015-01-07 | Trial | New trial registered: 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder | Trial register ClinicalTrials.gov |
| 2014-04-14 | Results | Results posted: Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder | Trial register ClinicalTrials.gov |
| 2011-06-27 | Trial | New trial registered: Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder | Trial register ClinicalTrials.gov |
| 2007-01-22 | Trial | New trial registered: Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) | Trial register ClinicalTrials.gov |