Daewoong Pharmaceutical announced that it has presented a mathematical analysis of the internal action mechanism of its new anti-diabetic drug, Envlo, at an international conference, reinforcing the scientific foundation for its global expansion efforts.
On June 24, Daewoong Pharmaceutical revealed that during the ‘2025 Population Approach Group in Europe (PAGE)’ conference held in Greece from June 3 to 4, it showcased a poster featuring the results of population pharmacokinetic (PK) modeling research on Enblow, an SGLT-2 inhibitor-based diabetes medication.
The study was conducted in collaboration with the Department of Clinical Pharmacology at Seoul National University Hospital. It was based on clinical data from 446 Korean patients and involved building a mathematical model to predict how the drug is absorbed, distributed, and eliminated in the body. The model specifically accounts for various physiological variables such as patient age, meal status, liver and kidney function, enabling precise analysis of differences in drug action.
To accurately reflect Enblow’s distribution within the body, researchers adopted a three-compartment (3-compartment) model dividing the body into three virtual spaces. The analysis identified age as a factor significantly affecting drug clearance, and meal timing as a key influence on absorption time.
The model demonstrated high reliability and accuracy through various metrics, including goodness-of-fit analysis (GOF), residual analysis analyzing prediction errors, and visually predictive checks (VPC) based on simulations.
Professor Seung-Hwan Lee of Seoul National University Hospital noted, “This study provides a quantitative understanding of Envlo’s pharmacokinetics and lays the groundwork for designing individualized treatment strategies. It is expected to contribute significantly to precision medicine-based drug therapy.”
Building on these results, Daewoong Pharmaceutical plans to utilize this PK model for personalized dosage adjustments in specific patient groups such as the elderly and those with liver or kidney impairments. The company also aims to apply the findings toward expanding indications and developing combination therapies.
Sungsoo Park, CEO of Daewoong Pharmaceutical, stated, “The modeling built in collaboration with Seoul National University Hospital will serve as a core basis for enhancing Envlo’s competitiveness in the global market. We are committed to establishing a strategic pathway for global approval and transforming Envlo into a blockbuster new drug.”
Meanwhile, Envlo is a domestically developed, 36th New Drug of Korea, and is Korea’s first SGLT-2 inhibitor designed for type 2 diabetes treatment. Its high efficacy at low doses (0.3 mg) has been well documented, with ongoing research into its benefits for weight loss, blood pressure and lipid profile improvement, and insulin resistance reduction.
