Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for patients with acquired hypothalamic obesity

Rhythm Pharmaceuticals

19 March 2026 - Rhythm Pharmaceuticals today announced that the US FDA has approved an expanded indication for Imcivree (setmelanotide) to treat patients living with acquired hypothalamic obesity.

The approval is supported by the positive pivotal Phase 3 TRANSCEND trial of setmelanotide in 142 patients with acquired hypothalamic obesity.

Read Rhythm Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration