November 18, 2025 — Leads & Copy — HLS Therapeutics Inc. (TSX: HLS) has received Health Canada approval for NILEMDO® (bempedoic acid) for reducing LDL-cholesterol in Canadian patients.
The approval is for patients who need additional LDL-cholesterol reduction and is supported by data from the CLEAR Outcomes trial involving nearly 14,000 patients. The data demonstrated a reduction in cardiovascular risk. The commercial launch is expected in the second quarter of 2026. This approval strengthens HLS’s position as a leading Canadian cardiovascular company.
NILEMDO, also known as NEXLETOL® in the U.S., is a once-daily oral therapy. It reduces LDL-C and the risk of major cardiovascular events in adults needing additional LDL-C lowering due to an inability to reach target levels with available therapies or statin intolerance.
Cardiovascular disease is the second leading cause of death in Canada, with many high-risk patients unable to achieve guideline-recommended LDL-C targets. Internal company estimates suggest that over half a million Canadians could benefit from bempedoic acid.
Dr. George Thanassoulis, a cardiology professor at McGill University and co-lead author of the Canadian Cardiovascular Society Lipid Guidelines, noted that many Canadians cannot reach their LDL-C targets even with recommended treatments. He stated that NILEMDO represents an important new option for these patients, including those who cannot tolerate statins, providing a greater opportunity to reduce cardiovascular risk and improve patient outcomes.
The CLEAR Outcomes trial, which included nearly 14,000 patients, demonstrated a significant reduction in major adverse cardiovascular events (MACE) in patients unable to take statin therapy. NILEMDO offers a novel oral pathway for LDL-C lowering and is less likely to cause muscle-related side effects that limit statin adherence. It can be used alone or with other LDL-lowering therapies, such as statins, ezetimibe, and PCSK9 inhibitors.
Craig Millian, CEO of HLS Therapeutics, stated that the approval is a major milestone for HLS and Canadians managing their cardiovascular health. He believes NILEMDO strengthens their cardiovascular portfolio and positions HLS as a leader in novel oral CV medicines in Canada, along with Vascepa®. The launch is planned for Q2 2026, and NILEMDO is expected to play a significant role in their future growth, helping more Canadians reach their LDL-C goals and reduce cardiovascular risk.
NILEMDO will be added to Health Canada’s Register of Innovative Drugs and will benefit from eight years of data protection from its November 17, 2025, approval, providing market exclusivity until 2040 through existing and pending patents.
HLS also received a Notice of Non-Compliance (NON) from Health Canada for NEXLIZET®, indicating deficiencies in the new drug submission following initial review. Health Canada did not raise concerns about the clinical data, efficacy, or safety but requested further clarification and additional data on CMC (chemistry, manufacture, and controls) and biopharmaceutics matters.
Millian added that HLS is working with Esperion to address the regulatory requirements for NEXLIZET and aims to respond to Health Canada as quickly as possible. NEXLIZET is currently approved and marketed in the U.S., Europe, and other global markets.
HLS Therapeutics Inc. was formed in 2015 and focuses on acquiring and commercializing late-stage development, commercial stage promoted, and established branded pharmaceutical products in North America, targeting the central nervous system and cardiovascular therapeutic areas.
Contact: Craig Millian, CEO of HLS Therapeutics.
Source: HLS Therapeutics Inc.
