Ministry of Health, Labour and Welfare (MHLW), with the Pharmaceuticals and Medical Devices Agency (PMDA) doing the scientific review and safety monitoring
Is Semaglutide legal in Japan?
The regulator has approved it as a medicine.
PMDA lists Ozempic (type 2 diabetes, 23 March 2018), Rybelsus tablets (29 June 2020), Wegovy (obesity, 27 March 2023) and the insulin icodec plus semaglutide combination Kyinsu (19 February 2026). Wegovy gained a second indication on 19 June 2026 for metabolic dysfunction-associated steatohepatitis with moderate or advanced fibrosis. The obesity indication is limited to people with hypertension, dyslipidaemia or type 2 diabetes 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 June 2026) restricts use to qualified facilities and says it must not be used for slimming or dieting. Ozempic, Rybelsus and Wegovy are on the NHI price list applicable from 13 August 2026.
Last verified 2026-09-29 · how we verify
Semaglutide elsewhere
Sources (5)
- 01Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026-09 · accessed 2026-09-29
- 02List of Approved Drugs, April 2004 to February 2026 (new drugs)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026 · accessed 2026-09-29
- 03Optimal Use Promotion Guideline: semaglutide (Wegovy), obesity (revised June 2026)Ministry of Health, Labour and Welfare (MHLW) · 2026-06 · accessed 2026-09-29
- 04NHI drug price list and generic drug information, applicable from 13 August 2026 (薬価基準収載品目リスト)Ministry of Health, Labour and Welfare (MHLW) · 2026-08-13 · accessed 2026-09-29
- 05Notice on proper use of GLP-1 receptor agonists and GIP/GLP-1 receptor agonists (医薬安発0616第16号)Ministry of Health, Labour and Welfare (MHLW) · 2026-06-16 · accessed 2026-09-29