Health Canada has granted approval for NILEMDO (bempedoic acid) to reduce LDL-cholesterol in Canadians at risk of cardiovascular disease, marking a significant regulatory milestone for Esperion Therapeutics and its Canadian partner HLS Therapeutics Inc. The commercial launch is anticipated for the second quarter of 2026.
Addressing Critical Medical Need in Canada
The approval comes at a crucial time for Canadian healthcare, as cardiovascular disease represents a substantial public health burden. According to Government of Canada data, approximately one in 12 Canadian adults aged 20 and over—representing 2.6 million people—are living with diagnosed heart disease. The condition stands as the second leading cause of death in Canada, with approximately 14 Canadian adults aged 20 and over dying every hour due to diagnosed heart disease.
"This approval marks another important milestone in our global strategy to expand access to bempedoic acid products for patients who urgently need better options to manage their LDL-C and reduce cardiovascular risk," said Sheldon Koenig, President and CEO of Esperion. "We remain deeply committed to delivering innovative therapies that address unmet medical needs and improve outcomes for patients around the world."
Non-Statin Alternative for Cholesterol Management
NILEMDO represents part of Esperion's portfolio of oral, once-daily, non-statin medicines designed for patients at risk for cardiovascular disease who struggle with elevated low-density lipoprotein cholesterol (LDL-C). These medications are distinguished as the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines in this therapeutic category.
The therapeutic approach is supported by robust clinical evidence from the CLEAR Cardiovascular Outcomes Trial, which included nearly 14,000 patients. This substantial clinical program provides the foundation for the drug's efficacy and safety profile in cardiovascular risk reduction.
Partnership and Commercial Strategy
The Canadian approval was achieved through Esperion's partnership with HLS Therapeutics Inc., which holds development and commercialization rights for both NILEMDO (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) in Canada. This collaboration represents part of Esperion's broader international expansion strategy through strategic partnerships and collaborations.
Pipeline Development and Future Prospects
Beyond the current approval, Esperion continues advancing its next-generation program focused on developing ATP citrate lyase inhibitors (ACLYi). The company leverages new insights into the structure and function of ACLYi to enable rational drug design, with the goal of developing highly potent and specific inhibitors with allosteric mechanisms.
The Canadian approval of NILEMDO reinforces Esperion's evolution into a leading global biopharmaceutical company through commercial execution, international partnerships, and advancement of its pre-clinical pipeline, providing additional treatment options for patients with cardiovascular disease risk factors.
