Daewon Pharmaceutical has demonstrated up to 3.14 times higher drug exposure in human studies for its novel oral diabetes and obesity treatment, which utilizes the company’s proprietary oral drug delivery platform, compared to existing therapies.
The company announced on Friday that it will present two research findings on its oral semaglutide DW5324 at the 2026 American Association of Pharmaceutical Scientists Annual Meeting (AAPS PharmSci 360), scheduled from October 25 to 28 in New Orleans.
DW5324 incorporates Daewon’s innovative oral drug delivery platform. This technology uses a polymer-lipid complex to shield peptide components from digestive enzymes and enhance absorption through the gastrointestinal mucosa.
Preclinical studies using the Parallel Artificial Membrane Permeability Assay (PAMPA) showed up to 6.00 times higher permeability compared to the control group. In animal trials with beagles, a single dose increased the area under the curve (AUC) by up to 6.41 times.
Notably, two human pharmacokinetic (PK) crossover studies comparing DW5324 with Novo Nordisk’s oral semaglutide Rybelsus (14 mg) yielded promising results. Studies involving 18 and 19 participants showed that the AUC of DW5324 was 1.90 to 3.14 times higher than Rybelsus, with maximum blood concentration (Cmax) increasing by up to 2.90 times.
This technology distinguishes itself by not using the absorption enhancer SNAC commonly found in existing oral semaglutide formulations. Daewon claims its unique non-SNAC formulation design could potentially overcome patent barriers associated with current technologies.
Founded in 1958, Daewon Pharmaceutical reported consolidated revenue of 605.4 billion KRW (approximately 456.8 million USD) last year, maintaining an 11% average annual growth rate over the past decade.
The company’s portfolio includes 12 pharmaceutical products with annual sales exceeding 10 billion KRW (approximately 7.5 million USD) each, including Pelubi, South Korea’s 12th domestically developed new drug, an anti-inflammatory analgesic, along with Codaewon and Coldaewon.
Last year, Daewon invested 54 billion KRW (approximately 40.7 million USD) in research and development (R&D), expanding its new drug development pipeline to include treatments for gastroesophageal reflux disease, uterine fibroids, and obesity.
Currently, Daewon exports its pharmaceuticals and products to 45 countries across Asia, Latin America, and the Middle East. The company is also pursuing global technology transfers leveraging its proprietary drug delivery platform.
Following the conference presentation, Daewon plans to optimize the formulation and file for a domestic Phase 1 clinical trial (IND) in 2027. The company will also initiate discussions with global pharmaceutical firms regarding potential platform technology transfers, based on its accumulated research data.
Kim Joo-il, Vice President and head of R&D at Daewon Pharmaceutical, stated that this breakthrough demonstrates the proprietary oral drug delivery platform’s potential to address both patent barriers and absorption limitations in peptide oral administration. It aims to optimize the formulation to meet global standards, pursue technology exports, and expand the platform’s application to various biopharmaceuticals.
