SUN-662 Exploring Adverse Drug Reactions Associated With Setmelanotide- A Pharmacovigilance Study

Abstract Disclosure: A. Sharma: None. J.P. Scarano Pereira: None. Setmelanotide is a melanocortin 4 receptor (MCR-4) agonist which was approved by U.S. Food and Drug Administration (FDA) in 2020 for weight management in patients above 6 years of age suffering from obesity due to genetic conditions such as Proopiomelanocortin (POMC) deficiency, Leptin receptor deficiency and Bardet-Biedl syndrome. It targets the melanocortin pathway in the hypothalamus, addressing the hyperphagia and weight management issues in these patients through its appetite-suppressant effects. While the drug has demonstrated promising therapeutic effects, pharmacovigilance is essential to assess its safety profile in real-word settings, particularly due to the rarity and complexity of the conditions it treats. In this study, we used the FDA Adverse Event Reporting System (FAERS) to analyze the reported adverse events for Setmelanotide from 2020 to 2024. The data was characterized based on reaction groups and age groups. Descriptive analysis was used to summarize these reports. A total of 93 cases were reported in this period and of these cases, 58 were reported by medical professionals while 33 cases were reported by patients themselves. The sex distribution revealed that 52 cases were reported in females while males accounted for 30 cases and sex was not specified for 11 cases. Most adverse reactions were reported in the age group of 18-64years (27cases) followed by 12-17years (24 cases) and a total of 18cases lacked an age specification. The most frequently noted adverse reactions included administration site reactions reported in 49 cases, followed by gastrointestinal reactions like nausea, vomiting, diarrhea reported in 41 cases. Skin effects including hyperpigmentation, discoloration was reported in 38 cases. Notably, there were no reported deaths related to Setmalanotide use during this period. Overall, Setmelanotide offers a generally favorable safety profile. Majority of the adverse events were mild and localized. These findings suggest that Setmelanotide continues to be a valuable treatment option for patients with rare genetic conditions associated with obesity. Further studies and post market surveillance is needed to assess the long-term effects of Setmelanotide especially with patients having comorbidities. Presentation: Sunday, July 13, 2025