Health Canada
Is Setmelanotide legal in Canada?
Approved, restrictedApproved as Imcivree for weight management in acquired hypothalamic obesity, BBS and specific genetic deficiencies
Approved, but with limits on who can get it or how.
Health Canada authorised Rhythm Pharmaceuticals' Imcivree (marketed since 2023-07-12). The monograph revised 2026-09-18 covers weight management in ages 4 and up with acquired hypothalamic obesity, and in ages 6 and up with obesity from Bardet-Biedl syndrome or from genetically confirmed POMC, PCSK1 or LEPR deficiency. It says setmelanotide is not indicated for other types of obesity, including general obesity.
Last verified 2026-09-29 · how we verify
Setmelanotide elsewhere
Sources (3)
- 01Drug Product Database: IMCIVREE product recordHealth Canada (Drug Product Database) · 2026-09 · accessed 2026-09-29
- 02Product Monograph: IMCIVREE (setmelanotide injection)Rhythm Pharmaceuticals / Q&C Services · 2026-09-18 · accessed 2026-09-29
- 03Drug Product Database API: active-ingredient search for setmelanotideHealth Canada (Drug Product Database) · 2026-09-29 · accessed 2026-09-29