Rhythm Pharmaceuticals launches IMCIVREE in Japan for hypothalamic obesity

Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) has launched IMCIVREE (setmelanotide) in Japan for the treatment of acquired hypothalamic obesity (HO), following the drug's inclusion on Japan's National Health Insurance drug price list.

The commercial launch follows approval by Japan's Ministry of Health, Labour and Welfare in August 2026. According to the company, IMCIVREE is the first approved therapy in Japan for acquired HO. Rhythm estimates that approximately 5,000 to 8,000 people in Japan are living with the condition.

The approval was supported by data from the Phase 3 TRANSCEND trial, which enrolled 142 patients with acquired HO, including 12 patients from a Japanese cohort. The trial met its primary endpoint, showing an 18.8% placebo-adjusted reduction in body mass index.

Setmelanotide has also received orphan drug designation from the MHLW for the treatment of acquired hypothalamic obesity.

"This launch marks an important advancement for people living with acquired HO in Japan where there were no approved therapies for this disease until now," said Yann Mazabraud, Executive Vice President and Head of International at Rhythm.

IMCIVREE is already approved in the United States, the European Union, and the United Kingdom for acquired HO and certain rare genetic forms of obesity. The information in this article is based on a statement issued by Rhythm Pharmaceuticals.

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