BOSTON — September 22, 2026
Rhythm Pharmaceuticals announced that Health Canada has approved IMCIVREE® (setmelanotide) for weight management in adult and pediatric patients 4 years of age and older with acquired hypothalamic obesity (HO). The approval makes IMCIVREE the first targeted therapy approved in Canada for acquired HO. IMCIVREE was previously approved in Canada for certain forms of genetically driven obesity, including obesity associated with Bardet-Biedl syndrome and genetically confirmed POMC, PCSK1 or LEPR deficiency.
IMCIVREE Targets MC4R Pathway in Acquired HO
IMCIVREE is a melanocortin-4 receptor (MC4R) agonist designed to address dysfunction in the MC4R pathway associated with acquired hypothalamic obesity. Acquired HO can develop following injury to the hypothalamus, including injury associated with hypothalamic-pituitary tumors and their treatment, and may result in accelerated and sustained weight gain, hyperphagia and reduced energy expenditure. The condition can also follow traumatic brain injury, stroke, infection or inflammation. Rhythm said the Canadian approval provides an additional treatment option for eligible adults and children with acquired HO, a rare condition with limited treatment options.
Phase 3 TRANSCEND Data Support Canadian Approval
Health Canada’s approval was supported by results from the pivotal Phase 3 TRANSCEND trial, which enrolled 142 patients with acquired hypothalamic obesity. The global study met its primary endpoint and demonstrated a statistically significant 18.8% placebo-adjusted reduction in body mass index (BMI) with setmelanotide. Results from the Phase 3 TRANSCEND study were also recently published in The New England Journal of Medicine. The trial data formed the clinical basis for evaluating setmelanotide as a targeted treatment for acquired HO associated with impaired MC4R pathway signaling.
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Rhythm Expands Access to IMCIVREE in Canada
Following the Health Canada approval, Rhythm plans to support access to IMCIVREE for eligible patients with acquired HO across Canada. The approval expands the geographic and age-specific availability of setmelanotide for hypothalamic obesity, complementing existing approvals in the United States, European Union and United Kingdom. Rhythm is also advancing a broader clinical development program for setmelanotide in additional rare diseases, alongside investigational MC4R agonists bivamelagon and RM-718 and preclinical small molecules targeting congenital hyperinsulinism. The company continues to focus its commercial and development activities on rare neuroendocrine diseases.
Source :Rhythm Pharmaceuticals, press release
