日本語 
Rhythm Pharmaceuticals is now selling IM CIVREE in Japan. The drug contains setmelanotide, which helps patients who have acquired obesity. The launch is possible because the medicine was added to Japan’s National Health Insurance price list. IM CIVREE is now the approved treatment for this type of obesity. Acquired hypothalamic obesity can happen when the hypothalamus, a part of the brain that controls hunger, energy and weight is damaged.
The launch comes after the Ministry of Health Labour and Welfare approved the drug in August 2026. Rhythm Pharmaceuticals estimates that about 5,000 to 8,000 people in Japan have acquired obesity. Rhythm Pharmaceuticals had also earned orphan drug status for setmelanotide for this condition.
Addressing a Rare Form of Obesity
Acquired obesity is not the same as regular obesity. It can arise when the hypothalamus is injured or damaged. This damage often occurs after treatment for brain tumours or other diseases that affect that area.
When the hypothalamus is damaged hunger signals and the body’s energy use can become upset. The result is hunger and quick weight gain. These changes make it very hard for patients to keep their weight under control.
IM CIVREE works by activating the melanocortin‑4 receptor or MC4R pathway. This pathway helps regulate hunger and energy balance. Setmelanotide, which is, in IM CIVREE targets this pathway to fix the problems that cause acquired hypothalamic obesity.
The Japanese launch expands the choices to patients who had no approved medicine for this condition before. Still whether a patient can use IM CIVREE and how well it will work depends on medical evaluation and the official prescribing information, for the drug.
Phase 3 Trial Supported Japanese Approval
Japan’s regulatory approval was supported by results from the Phase 3 TRANSCEND trial. The global study included 142 patients with acquired obesity. This group had 12 patients from Japan and 10 additional participants outside the 120-patient pivotal cohort.
Rhythm said the study reached its endpoint. It showed a significant 18.8% placebo-adjusted reduction in body mass index (BMI). This means the treatment group had a drop in BMI compared to the placebo group. The number reflects the difference between groups. Does not mean every patient lost the same amount of weight.
The results offer proof that the treatment can help people with acquired hypothalamic obesity. Clinical studies are still key, to understanding both the benefits and risks. As the medicine becomes available in Japan doctors and healthcare professionals will have to assess how best to use it. They will need to monitor patients and take into account each person’s medical history and condition following the approved product information.
National Health Insurance Listing Enables Commercial Availability
The commercial launch followed IMCIVREE’s addition to Japan’s National Health Insurance drug price list. This step establishes the medicine’s listed price within the country’s public health insurance system and supports its introduction into routine healthcare channels.
The development also shows how Japan’s regulatory and reimbursement processes play a role in getting treatments for rare diseases into the hands of patients. Marketing authorization means a medicine can be sold for its approved use.. Pricing and reimbursement are just as important because they determine whether patients can actually get the medicine in practice.
Rhythm said it has been growing its team in Japan to get ready for the launch. The company’s international operations will help support its work to make the medicine available to patients and to healthcare providers across the country.
How many patients end up getting the treatment will depend on how many’re diagnosed, whether they meet clinical criteria how much healthcare professionals know about the condition and how well the medicine fits into Japan’s healthcare system. The company estimates that between 5,000 and 8,000 people, in Japan have the condition. That number is the potential patient population, not the number expected to actually receive treatment.
A Wider Step in Rare-Disease Treatment
The Japanese launch is a part of Rhythm Pharmaceuticals’ efforts focused on rare neuroendocrine diseases. The company is working on treatments that focus on the pathways that control hunger and body weight.
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For people with acquired obesity the arrival of an approved therapy offers a new way to deal with a condition that brings big and lasting weight-related problems. The effect of this treatment in Japan will depend on how it works in medical settings and how well doctors can find patients who need it.
This launch also shows a trend in medicine toward treatments that are made for specific causes of disease instead of looking at obesity as one single issue. As targeted medicines become available for clearly defined groups of patients making the right diagnosis having strong medical proof and arranging access will stay very important.
Now that IMCIVREE is available, in Japan the next step will be to start using it in medical settings and keep checking how well patients do when they take the treatment.
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