Daewon Pharmaceutical accelerates oral obesity drug development, achieving up to 3.14x higher drug exposure

Daewon Pharmaceutical is accelerating development of an oral treatment for diabetes and obesity using its proprietary drug delivery technology. A human pharmacokinetic study comparing the formulation against an existing oral semaglutide treatment showed drug exposure up to 3.14 times higher, confirming the potential of a next-generation oral treatment.

Daewon Pharmaceutical said Friday it will present two research findings on its oral semaglutide candidate DW5324 at the 2026 AAPS PharmSci 360 annual meeting of the American Association of Pharmaceutical Scientists, to be held in New Orleans from Sunday through Wednesday (local time).

The presentations will cover preclinical and human pharmacokinetic (PK) study results for semaglutide formulated using the company's proprietary oral drug delivery platform.

Daewon Pharmaceutical developed the platform — which uses a polymer-lipid complex — to improve drug absorption in the body. The technology is designed to protect the active ingredient in the gastrointestinal tract, control the timing of its release and enhance permeability through the gastrointestinal mucosa.

In a parallel artificial membrane permeability assay (PAMPA), the formulation showed up to six times greater permeability than the control. In animal studies using beagles, a single dose produced up to a 6.41-fold increase in drug exposure, as measured by area under the curve (AUC).

The absorption improvement was also confirmed in a human pharmacokinetic crossover study directly comparing the formulation against Rybelsus, the 14-milligram oral semaglutide treatment made by Novo Nordisk.

Across two studies involving 18 and 19 participants respectively, the Daewon Pharmaceutical formulation showed 1.90 to 3.14 times higher drug exposure than Rybelsus. Peak plasma concentration (Cmax) was also up to 2.9 times higher.

Daewon Pharmaceutical said it secured a differentiated drug delivery platform through its own formulation design without using SNAC, the absorption enhancer found in existing oral semaglutide products. The company plans to use this foundation to navigate patent barriers and expand its development of oral peptide drugs.

Oral treatments offer the advantage of self-administration compared with injectable drugs, but the low oral bioavailability of peptide compounds remains a key challenge in development. Daewon Pharmaceutical said it is focused on overcoming this technical limitation through its proprietary drug delivery technology.

Following the conference presentations, the company plans to optimize the formulation further and file an investigational new drug (IND) application for a domestic Phase 1 trial in 2027. It also intends to pursue technology transfer discussions with global pharmaceutical companies based on the accumulated research data.

"We will further optimize the formulation to meet global standards, make product development and global technology exports a tangible reality, and go on to expand the platform's application to a range of biopharmaceuticals — positioning ourselves as a game changer in the non-invasive drug delivery market," said Kim Ju-il, executive vice president and head of research and development at Daewon Pharmaceutical.