Ministry of Health, Labour and Welfare (MHLW), with the Pharmaceuticals and Medical Devices Agency (PMDA) doing the scientific review and safety monitoring
Is Setmelanotide legal in Japan?
Approved, restrictedApproved on 24 August 2026 as Imcivree, only for acquired hypothalamic obesity; not yet on the NHI price list
Approved, but with limits on who can get it or how.
MHLW approved Rhythm Pharmaceuticals' Imcivree (setmelanotide) on 24 August 2026 as a new active ingredient for acquired hypothalamic obesity, with orphan drug designation. PMDA's package-insert database now shows a package insert and review report for it. The approval covers that one indication only, and it does not extend to other forms of obesity. The product does not appear in the NHI price list applicable from 13 August 2026, which predates the approval.
Last verified 2026-09-29 · how we verify
Setmelanotide elsewhere
Sources (3)
- 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
- 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