Korea United Pharm to launch fixed-dose lipid-lowering combo

Korea United Pharm is expanding its cardiovascular drug portfolio with the upcoming Aug. 1 launch of Pitaric, a fixed-dose combination therapy approved to treat mixed dyslipidemia.

The Ministry of Food and Drug Safety approved the therapy on May 29. Pitaric combines pitavastatin calcium 2 mg with fenofibric acid 110 mg and is indicated for patients with elevated triglycerides and low HDL cholesterol despite controlled LDL levels.

According to the company, the capsule uses Korea United’s proprietary EH (EnHanced Bioavailability) technology to boost fenofibric acid absorption, allowing for therapeutic effect even at the lowest dose approved domestically. 

Because fenofibric acid is already in its active form, it does not require metabolic conversion and can be taken regardless of meals.

Korea United added that it applied an enteric coating that delays drug release until it reaches the intestine, aiming to reduce the gastrointestinal side effects often seen with dyslipidemia medications. 

The formulation also includes alkalinizing and solubilizing agents to enhance drug solubility and minimize patient-to-patient variability in absorption.

Both active pharmaceutical ingredients are synthesized and manufactured in-house, giving Korea United full vertical control over the product’s supply chain. The company said this ensures production stability and consistent quality.