What kind of medicine does olezarsen belong to? In which countries is it currently available?

Olezarsen is an antisense oligonucleotide (ASO). Its main mechanism of action is to target and inhibit the expression of APOC3 gene, thereby significantly reducing triglyceride levels in the blood. APOC3 is an apolipoprotein closely related to lipid metabolism. Inhibiting its expression can accelerate the decomposition of triglycerides and improve dyslipidemia. The drug is currently mainly used to treat severe hypertriglyceridemia such as familial chylomicronemia syndrome (FCS). It is a cutting-edge precision targeted lipid-lowering treatment.

Olezasen was developed byIonis Pharmaceuticals and is one of the masterpieces of next-generation antisense nucleic acid technology. Compared with traditional lipid-lowering drugs (such as fibrates, statins, fish oils, etc.), the mechanism of Olezasen is more targeted and is especially suitable for patients who have poor response to conventional drugs or have severe lipid metabolism disorders. It offers new options to address complications such as the risk of pancreatitis and atherosclerosis associated with extremely high triglycerides.

In terms of marketing progress, as of 2025, Olezasen has not yet been approved for marketing in mainland China, but it has entered the clinical application stage or submitted marketing applications in some countries and regions. At the end of 2023, the US FDA has granted it "breakthrough therapy" designation for the treatment of FCS, and it has been approved for marketing at the beginning of 2024 for patients with specific types of hypertriglyceridemia. The European Medicines Agency (EMA) is also advancing the relevant review procedures and is expected to complete marketing approval in some European countries soon.

In addition to the United States, Olezacen has also launched early access plans or compassionate use mechanisms in Canada, Australia, and some developed countries in the Asia-Pacific region, especially for patients with rare hereditary hypertriglyceridemia. Globally, the drug is gradually expanding into countries where it is listed and is expected to cover more markets in the next few years, especially in countries and regions with a heavy burden of lipid metabolism diseases. For Chinese patients, if they currently need to use Olezasen, they still need to rely on overseas drug purchase channels or obtain it through cross-border medical institutions.

Reference materials:https://www.drugs.com/