Rhythm begins Japanese sales of IMCIVREE for acquired hypothalamic obesity

Rhythm Pharmaceuticals started selling IMCIVREE (setmelanotide) in Japan on Oct. 13, 2026, for acquired hypothalamic obesity. The launch came after Japan’s Ministry of Health, Labour and Welfare authorized the drug in August and added it to the National Health Insurance pricing system. Rhythm said this is the country’s first authorized treatment for the condition and estimates that 5,000 to 8,000 people in Japan may be affected.

The decision gives Rhythm access to Japan’s reimbursed medicines market for this indication and creates a new commercial opportunity. Rhythm’s estimate indicates a potential Japanese patient population of 5,000 to 8,000 people, though future uptake and revenue are not yet reported.

  • 1Rhythm began commercial sales of IMCIVREE in Japan on Oct. 13, 2026, after MHLW approval in August and placement on Japan’s National Health Insurance drug price list.
  • 2Rhythm estimates that 5,000 to 8,000 people in Japan live with acquired hypothalamic obesity.
  • 3The Phase 3 TRANSCEND study enrolled 142 patients, including 12 from a Japanese cohort and 10 additional supplemental patients.
  • 4TRANSCEND produced an 18.8% placebo-adjusted reduction in body mass index.

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