Is Tirzepatide legal in Japan?

PMDA lists Mounjaro (type 2 diabetes, 26 September 2022) and Zepbound (obesity, 27 December 2024). On 18 May 2026 Zepbound gained an indication for moderate or worse obstructive sleep apnoea with a BMI of 27 or more, and its obesity wording was updated. Under the 18 May 2026 wording, the obesity indication is limited to people with hypertension, dyslipidaemia or impaired glucose metabolism (type 2 diabetes, impaired glucose tolerance and similar) who did not respond enough to diet and exercise and who have a BMI of 35 or more, or 27 or more with two or more obesity-related conditions. MHLW's Optimal Use Promotion Guideline (revised May 2026) still asks that patients have a diagnosis of hypertension, dyslipidaemia or type 2 diabetes, limits use to qualified facilities, allows at most 72 weeks in a course, and excludes slimming or cosmetic use. Both brands are on the NHI price list applicable from 13 August 2026, with new Mounjaro prices marked from 1 August 2026.