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Rhythm Pharmaceuticals

Rhythm Pharmaceuticals

Biopharmaceutical Company

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FDA expands treatment options for obesity with rare and mainstream drug approvals

New Capabilities

Expanding Imcivree into its largest indication yet while developing next-generation MC4R agonists

For patients who gained severe, uncontrollable weight after brain tumor surgery—often as children—there has never been an approved medication. That changed on March 19, 2026, when the Food and Drug Administration (FDA) approved Imcivree (setmelanotide) for acquired hypothalamic obesity, a condition affecting roughly 10,000 Americans whose damaged hypothalamus makes diet and exercise essentially useless. In clinical trials, patients lost 18.4% more body mass than those on placebo over one year.

Updated 2 hours ago