Rhythm Pharmaceuticals has received approval from Japan’s Ministry of Health, Labour and Welfare for IMCIVREE, or setmelanotide, to treat acquired hypothalamic obesity.
IMCIVREE is the first treatment approved in the country specifically for acquired hypothalamic obesity.
Rhythm expects to make IMCIVREE available in Japan before the end of 2026, subject to final pricing arrangements. This means the regulatory risk has been reduced, while pricing and commercial execution now become the main factors determining how quickly the Japanese opportunity can begin contributing to the business.
Rhythm estimates that around 5,000 to 8,000 people in Japan are living with acquired hypothalamic obesity.
Acquired hypothalamic obesity can occur following damage to the hypothalamus, including after surgery or treatment for certain tumours. The condition can lead to rapid and difficult-to-control weight gain because the hypothalamus plays a central role in regulating hunger, energy use and body weight.
IMCIVREE is designed to act on the melanocortin-4 receptor pathway, known as the MC4R pathway. Rhythm has built its development strategy around rare forms of obesity where disruption of this pathway contributes to severe hunger and weight gain.
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