Rhythm launches IMCIVREE in Japan

• Rhythm Pharmaceuticals (NASDAQ:RYTM) launched IMCIVREE (setmelanotide) in Japan for patients with acquired hypothalamic obesity after national insurance price-list inclusion.
• The launch follows approval by Japan’s Ministry of Health, Labour and Welfare in August 2026 and orphan drug designation for the condition.
• Rhythm said approval was supported by Phase 3 TRANSCEND trial results showing an 18.8% placebo-adjusted reduction in body mass index.

Rhythm Pharmaceuticals (NASDAQ:RYTM) commercially launched IMCIVREE (setmelanotide) in Japan for patients with acquired hypothalamic obesity following its inclusion on the national insurance price list.

The treatment received approval from Japan’s Ministry of Health, Labour and Welfare in August 2026 after evaluation of clinical data from the Phase 3 TRANSCEND study.

The TRANSCEND trial enrolled 142 patients, including 12 participants from a Japanese cohort and 10 supplemental patients, and met its primary endpoint with a statistically significant placebo-adjusted BMI reduction of 18.8%.

Rhythm estimates approximately 5,000 to 8,000 people in Japan live with acquired hypothalamic obesity, a condition associated with disruption of hypothalamic function.

Rhythm Pharmaceuticals develops medicines for rare genetic and endocrine disorders, including treatments targeting pathways involved in appetite and energy regulation.