Japan approves Zepbound for obesity disease with narrower eligibility than the US
Japan cleared tirzepatide for obesity in a narrower patient group than the US label covers, a reminder that approval terms for the same drug differ by country.
Japan's Ministry of Health, Labour and Welfare approved Zepbound (tirzepatide) on December 27, 2024, for the chronic disease of "obesity disease" with multiple factors, Eli Lilly Japan and Mitsubishi Tanabe Pharma Corporation announced [1]. The approval covers adults who also have hypertension, dyslipidemia or type 2 diabetes and who do not adequately respond to diet or exercise therapy [1].
Eligibility under the Japanese label is set by two BMI thresholds: a BMI of at least 27 kg/m² in the presence of at least two obesity-related health conditions, or a BMI of at least 35 kg/m² [1]. Japan defines obesity itself as a BMI of at least 25, and "obesity disease" as a BMI of at least 25 accompanied by at least one obesity-related disorder that medically requires weight reduction [1]. The announcement does not describe how the US label for Zepbound defines who can receive it, so the two sets of criteria cannot be compared from this statement alone.
Zepbound is a long-acting GIP and GLP-1 receptor dual agonist given once weekly by subcutaneous injection using the ATEOS single-use autoinjector [1]. Six dose strengths are approved — 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg — the same range used for Mounjaro, which contains the same compound and has been sold in Japan for type 2 diabetes since April 2023 [1].
The approval rests mainly on Study SURMOUNT-J, a phase 3, randomized, double-blind, placebo-controlled trial in Japanese adults [1]. At week 72, mean change in body weight from baseline was −17.8 percent in the tirzepatide 10 mg group (n = 71) and −22.7 percent in the 15 mg group (n = 76), compared with −1.7 percent on placebo (n = 75) [1]. The share of participants losing at least 5 percent of body weight was 94.4 percent at 10 mg and 96.1 percent at 15 mg, versus 20.0 percent on placebo [1]. All participants received counseling on diet and exercise from registered dietitians or equivalent staff throughout the study, and the trial excluded people with diabetes [1].
"With the current approval of Zepbound, we are very pleased to offer an innovative treatment option for people living with obesity disease in Japan," said Gary Miles, chief officer of the Diabetes and Growth Hormone Division at Eli Lilly Japan [1]. Yasutaka Kuragaki, head of the Japan Pharmaceutical Business Division at Mitsubishi Tanabe Pharma, said obesity is caused by multiple factors including genetic, physical, psychological and social factors, and that stigma remains a social problem [1].
The announcement cites an estimate of 28 million people living with obesity in Japan and says obesity disease has not been diagnosed or treated as actively as other chronic diseases there [1].
Why it matters for patients
Approval terms are country-specific. A patient who takes Zepbound or Mounjaro in the United States is covered by the US label, not the Japanese one, and this decision does not change US availability, US prescribing criteria or US insurance coverage. Coverage terms in Japan were not disclosed in the announcement [1].
The Japanese criteria show a regulator drawing a tighter line than a broad obesity diagnosis, requiring a specific coexisting condition in every case and, below a BMI of 35, two obesity-related health conditions [1]. For readers who follow GLP-1 news, headlines about foreign approvals may describe who can get the drug elsewhere rather than what applies at home.
The trial itself enrolled adults without diabetes, while the approved Japanese label includes people with type 2 diabetes among those who may qualify [1]. The announcement does not say what data support use in that group.
What happens next
Mitsubishi Tanabe Pharma is responsible for sales and distribution of Zepbound in Japan, with both companies jointly providing information, as they do for Mounjaro [1]. A launch date and price have not been disclosed [1]. Both companies said they will continue research and activities involving people affected by obesity disease [1].
In the United States, tirzepatide has been marketed for obesity under the name Zepbound since December 2023, according to the announcement [1].
Sources
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