Japan approves Rhythm’s Imcivree for hypothalamic obesity

Japan's Ministry of Health, Labour and Welfare has approved Rhythm Pharmaceuticals' Imcivree for the treatment of acquired hypothalamic obesity, the first therapy authorized in the country for this rare disease. Acquired hypothalamic obesity, marked by rapid weight gain following hypothalamus damage, affects an estimated 5,000 to 8,000 people in Japan.

The approval stems from data from the Phase 3 TRANSCEND trial, which included 142 patients, including 12 Japanese and 10 supplemental participants. Imcivree, a melanocortin-4 receptor agonist, showed an 18.8% reduction in BMI compared to placebo. The drug is already approved in the U.S. and EU for similar uses and is currently being prepared for launch in Japan by the end of 2026, pending final pricing.