Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorization to IMCIVREE® (setmelanotide) to treat patients living with acquired hypothalamic obesity (HO).

IMCIVREE, a melanocortin-4 receptor (MC4R) agonist which received orphan drug designation by the MHLW in March 2025, is the first therapy approved in Japan to treat acquired HO. Rhythm expects to launch IMCIVREE before the end of 2026, pending final pricing determination.

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