| 2026-06-29 | Trial | New trial registered: Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity | Trial register ClinicalTrials.gov |
| 2026-05-29 | Results | Results posted: A Trial of Setmelanotide in Acquired Hypothalamic Obesity | Trial register ClinicalTrials.gov |
| 2026-04-22 | Federal Register | Federal Register rule: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System | Regulator Federal Register |
| 2026-04-01 | Label | FDA label revised: Imcivree (NDA213793) | Regulator FDA drug label register |
| 2026-03-27 | Trial | New trial registered: Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a) | Trial register ClinicalTrials.gov |
| 2025-05-31 | Results | Results posted: Long Term Extension Trial of Setmelanotide | Trial register ClinicalTrials.gov |
| 2025-01-13 | Trial | New trial registered: A Study of Setmelanotide in Patients With Prader-Willi Syndrome | Trial register ClinicalTrials.gov |
| 2025-01-07 | Trial | New trial registered: A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) | Trial register ClinicalTrials.gov |
| 2024-11-26 | Results | Results posted: Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway | Trial register ClinicalTrials.gov |
| 2024-10-24 | Results | Results posted: DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway | Trial register ClinicalTrials.gov |
| 2024-09-19 | Trial | New trial registered: Open-Label Extension Study of Setmelanotide | Trial register ClinicalTrials.gov |
| 2024-07-10 | Results | Results posted: Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity | Trial register ClinicalTrials.gov |
| 2024-05-03 | Results | Results posted: Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants | Trial register ClinicalTrials.gov |
| 2023-12-01 | Results | Results posted: Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Sev | Trial register ClinicalTrials.gov |
| 2023-09-21 | Results | Results posted: Open-Label Study of Setmelanotide in Hypothalamic Obesity | Trial register ClinicalTrials.gov |
| 2023-09-21 | Results | Results posted: Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity | Trial register ClinicalTrials.gov |
| 2023-08-18 | Results | Results posted: Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity | Trial register ClinicalTrials.gov |
| 2023-08-14 | Results | Results posted: Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants | Trial register ClinicalTrials.gov |
| 2023-08-07 | Results | Results posted: Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients | Trial register ClinicalTrials.gov |
| 2023-07-27 | Results | Results posted: Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome | Trial register ClinicalTrials.gov |
| 2023-05-23 | Results | Results posted: Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity | Trial register ClinicalTrials.gov |
| 2023-03-31 | Trial | New trial registered: Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity | Trial register ClinicalTrials.gov |
| 2023-03-20 | Trial | New trial registered: A Trial of Setmelanotide in Acquired Hypothalamic Obesity | Trial register ClinicalTrials.gov |
| 2022-08-03 | Federal Register | Federal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability | Regulator Federal Register |
| 2022-07-01 | Federal Register | Federal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; IMCIVREE | Regulator Federal Register |
| 2022-01-18 | Trial | New trial registered: Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway | Trial register ClinicalTrials.gov |
| 2022-01-11 | Trial | New trial registered: An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS) | Trial register ClinicalTrials.gov |
| 2021-10-26 | Trial | New trial registered: EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway | Trial register ClinicalTrials.gov |
| 2021-09-16 | Trial | New trial registered: Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants | Trial register ClinicalTrials.gov |
| 2021-07-19 | Trial | New trial registered: Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity | Trial register ClinicalTrials.gov |
| 2021-07-15 | Trial | New trial registered: DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway | Trial register ClinicalTrials.gov |
| 2021-01-26 | Trial | New trial registered: Open-Label Study of Setmelanotide in Hypothalamic Obesity | Trial register ClinicalTrials.gov |
| 2020-12-17 | Federal Register | Federal Register notice: Issuance of Priority Review Voucher; Rare Pediatric Disease Product | Regulator Federal Register |
| 2020-04-16 | Trial | New trial registered: A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment | Trial register ClinicalTrials.gov |
| 2018-11-19 | Trial | New trial registered: Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate | Trial register ClinicalTrials.gov |
| 2018-08-29 | Trial | New trial registered: Long Term Extension Trial of Setmelanotide | Trial register ClinicalTrials.gov |
| 2017-09-19 | Trial | New trial registered: Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity | Trial register ClinicalTrials.gov |
| 2017-08-25 | Trial | New trial registered: Setmelanotide in a Single Patient With Partial Lipodystrophy | Trial register ClinicalTrials.gov |
| 2017-01-06 | Trial | New trial registered: Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity | Trial register ClinicalTrials.gov |
| 2016-09-12 | Trial | New trial registered: Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity | Trial register ClinicalTrials.gov |
| 2015-05-29 | Trial | New trial registered: RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients | Trial register ClinicalTrials.gov |
| 2015-04-22 | Trial | New trial registered: Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers | Trial register ClinicalTrials.gov |
| 2014-12-08 | Trial | New trial registered: Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome | Trial register ClinicalTrials.gov |
| 2014-01-20 | Trial | New trial registered: Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients | Trial register ClinicalTrials.gov |
| 2013-05-22 | Trial | New trial registered: Effects of RM-493 on Energy Expenditure in Obese Individuals | Trial register ClinicalTrials.gov |
| 2012-12-13 | Trial | New trial registered: Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants | Trial register ClinicalTrials.gov |