Ministry of Health, Labour and Welfare (MHLW), with the Pharmaceuticals and Medical Devices Agency (PMDA) doing the scientific review and safety monitoring
Is Dulaglutide legal in Japan?
ApprovedApproved for type 2 diabetes as Trulicity, on the NHI price list; not approved for obesity
The regulator has approved it as a medicine.
PMDA lists Trulicity (dulaglutide) as a new active ingredient for type 2 diabetes, approved on 3 July 2015, with an additional dose form and strength approved on 24 June 2024. PMDA's package-insert database shows an updated Trulicity package insert dated 15 September 2026. Trulicity is on the NHI price list applicable from 13 August 2026. No obesity indication for dulaglutide appears in the approval lists.
Last verified 2026-09-29 · how we verify
Dulaglutide elsewhere
Sources (3)
- 01List of Approved Drugs, April 2004 to February 2026 (new drugs)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026 · accessed 2026-09-29
- 02Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026-09-29 · accessed 2026-09-29
- 03NHI 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