Daewon Pharmaceutical improves absorption of oral semaglutide... plans clinical trial in 2027

[Financial News] Daewon Pharmaceutical confirmed higher drug exposure than existing treatments in a human pharmacokinetic study of oral semaglutide using its proprietary drug-delivery technology. It plans to seek to file an IND for a Phase 1 clinical trial in Korea next year and explore global technology exports.
Daewon Pharmaceutical announced on the 23rd that it will present two sets of findings from preclinical and human pharmacokinetic (PK) studies of its oral semaglutide candidate, DW5324, at the 2026 Annual Meeting of the American Association of Pharmaceutical Scientists (AAPS PharmSci 360), to be held in New Orleans, United States, from the 25th to the 28th (local time).
According to Daewon Pharmaceutical, a formulation using its proprietary oral drug-delivery platform showed permeability up to six times higher than the control in a parallel artificial membrane permeability assay (PAMPA). Animal studies in beagles also found that a single dose increased drug exposure in the body (AUC) by up to 6.41 times.
Differences were also seen in two human pharmacokinetic crossover studies comparing the formulation with Novo Nordisk's Rybelsus, an existing oral semaglutide product. In studies involving 18 and 19 participants, respectively, the AUC for the DW5324-based formulation was 1.90 to 3.14 times that for 14 mg of Rybelsus. Peak blood concentration (Cmax) also increased by up to 2.90 times.
Semaglutide is a peptide drug used to treat diabetes and obesity. When taken orally, it can be easily broken down in the gastrointestinal tract and has low absorption, posing a limitation. Technologies that help the drug be absorbed into the body are therefore important for oral formulations.
Daewon Pharmaceutical developed a platform that uses polymer and lipid complexes to protect peptides from the digestive environment and regulate release timing and the efficiency of penetration through the gastrointestinal mucosa. In particular, it applied a formulation design that does not rely on SNAC, the absorption enhancer used in Rybelsus. The company plans to use this approach to address related patent barriers and expand the technology's applications to other biopharmaceuticals.
After this presentation, the company plans to further optimize the formulation and file an IND for a Phase 1 clinical trial in Korea in 2027. It will also pursue discussions with global pharmaceutical companies on licensing the platform technology, based on accumulated clinical data.
A Daewon Pharmaceutical official said, "We will further optimize the formulation of our oral drug-delivery platform to advance product development and pursue global technology exports, and expand its applications to a range of biopharmaceuticals."

[email protected] Jeong Sang-hui Reporter