{"entity":{"id":"setmelanotide","kind":"drug","name":"Setmelanotide","aka":["RM-493"],"tldr":"Setmelanotide is a daily injection that switches back on the brain's fullness signal. Approved for rare genetic causes of obesity, it is being tested for the relentless weight gain that follows damage to the hypothalamus from craniopharyngioma surgery or radiotherapy.","summary":"Setmelanotide is Rhythm Pharmaceuticals' melanocortin-4 receptor agonist. The FDA approved it in 2020 for chronic weight management in obesity due to POMC, PCSK1 or LEPR deficiency, and later for Bardet-Biedl syndrome. It is injected under the skin once daily and reduces hunger and weight in patients whose hypothalamic satiety pathway is broken upstream of the receptor.\n\nHypothalamic obesity after craniopharyngioma is an acquired lesion of the same pathway and resists diet and conventional drugs. A phase 2 trial showed weight loss in patients with acquired hypothalamic obesity, and a phase 3 trial followed. The craniopharyngioma page names it, with GLP-1 agonists and oxytocin, among the treatments under study for hypothalamic obesity.","status":"approved","asOf":"2026-09-17","wikipedia":"https://en.wikipedia.org/wiki/Setmelanotide","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Setmelanotide"}],"tags":["subtype-drugs-wave"],"related":[],"cancers":["craniopharyngioma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["rhythm-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Imcivree","modality":"Subcutaneous melanocortin-4 receptor agonist","mechanism":"Activates the melanocortin-4 receptor downstream of the leptin-POMC pathway in the hypothalamus, restoring the satiety signal that is lost when the hypothalamus is damaged by a craniopharyngioma or its treatment.","approvals":[{"region":"US","year":2020,"indication":"Chronic weight management in obesity due to POMC, PCSK1 or LEPR deficiency"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/setmelanotide/","neighbours":{"cancer":[{"id":"craniopharyngioma","kind":"cancer","name":"Craniopharyngioma","route":"/cancers/craniopharyngioma/"}],"company":[{"id":"rhythm-pharmaceuticals","kind":"company","name":"Rhythm Pharmaceuticals","route":"/companies/rhythm-pharmaceuticals/"}]}}