<img src="https://healthylife7.com/wp-content/uploads/2026/08/image-189.jpg” alt=”Rhythm’s Imcivree becomes first approved therapy for acquired hypothalamic obesity in Japan”>
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorization to Imcivree (setmelanotide) for acquired hypothalamic obesity (HO), making it the first approved therapy for this indication in Japan. Boston-based Rhythm Pharmaceuticals (Nasdaq: RYTM) holds the rights directly and said it expects a commercial launch before the end of 2026, pending final pricing determination. Rhythm estimates 5,000 to 8,000 patients in Japan are living with acquired HO
Acquired HO arises from injury to the hypothalamus — most commonly following treatment of craniopharyngioma, astrocytoma, or other hypothalamic-pituitary tumors — and results in impaired melanocortin-4 receptor (MC4R) pathway signaling, driving accelerated and sustained weight gain. Setmelanotide is a synthetic cyclic peptide MC4R agonist that restores downstream satiety signaling by mimicking endogenous alpha-melanocyte-stimulating hormone, the production of which is reduced by hypothalamic injury.
The approval is supported by the Phase III TRANSCEND trial, which enrolled 142 patients with acquired HO, including a 12-patient Japanese cohort. The study met its primary endpoint, reporting a statistically significant placebo-adjusted reduction in body mass index of -18.8%. Results were published in The New England Journal of Medicine. The MHLW had granted setmelanotide orphan drug designation for this indication in March 2025
The European Commission approved Imcivree for the same indication based on the same TRANSCEND dataset, and the US FDA has previously authorized the drug for acquired HO as well as for genetic obesity caused by POMC, PCSK1, or LEPR deficiency and Bardet-Biedl syndrome. No other pharmacological therapy is approved for acquired HO in Japan or other major markets. Saniona’s tesomet (tesofensine/metoprolol) has reached Phase II development but has been voluntarily paused due to funding constraints, leaving setmelanotide without a near-term approved or late-stage competitor in the indication.
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