Rhythm Pharmaceuticals, Inc. announced the commercial launch of Imcivree (setmelanotide) in Japan for the treatment of acquired hypothalamic obesity, following the drug’s inclusion on the country’s National Health Insurance (NHI) drug price list.
Acquired hypothalamic obesity (HO) is a rare condition resulting from injury or impairment of the hypothalamus, which regulates hunger and energy balance. The disorder can lead to accelerated, sustained weight gain and excessive hunger.
Japan’s Ministry of Health, Labour, and Welfare (MHLW) approved imcivree for acquired HO in August 2026. The company stated it is the first approved therapy for the condition in Japan.
Imcivree is a melanocortin-4 receptor (MCR4) agonist designed to address disruptions in the pathway involved in regulating hunger and body weight. Setmelanotide is approved in multiple markets for certain forms of rare obesity.
The Japanese approval was supported by results from the pivotal Phase 3 TRANSCEND trial, which enrolled 142 patients with acquired HO. The study included 12 patients from a Japanese cohort and 10 additional patients beyond the primary 120-patient cohort.
The global Phase 3 trial met its primary endpoint, demonstrating a statistically significant 18.8% placebo-adjusted reduction in body mass index (BMI).
Rhythm estimates that approximately 5,000 to 8,000 people in Japan are living with acquired HO.
Yann Mazabraud, Executive Vice President and Head of International at Rhythm, said, “This is a significant milestone in our global efforts to bring innovative therapies to patients with rare neuroendocrine diseases around the world.”