DW5324 oral semaglutide reaches higher blood levels than Rybelsus in early Daewon tests

Daewon Pharmaceutical says its DW5324 oral semaglutide reached higher blood levels than Rybelsus, the approved Novo Nordisk tablet, in two small human pharmacokinetic studies. The South Korean company reported total exposure 1.90 to 3.14 times that of Rybelsus and is presenting the work at the AAPS PharmSci 360 meeting in New Orleans this week. These are company figures shown at a conference, not a peer reviewed paper. No weight, blood sugar or safety results were released, and a formal phase 1 filing in Korea is not planned until 2027.

What Daewon reported from the AAPS meeting

According to Korea Biomedical Review, Daewon described two crossover studies that set its formulation directly against Rybelsus. In a crossover design each participant takes both products in turn, so every person acts as their own control. The studies enrolled 18 and 19 participants, the company said. Area under the curve, a measure of total drug exposure over time, came in 1.90 to 3.14 times higher than with Rybelsus, and peak plasma concentration was up to 2.90 times higher. The company did not say which result came from which study, how many versions or amounts of DW5324 were tested, or whether the volunteers were healthy adults or patients. A range this wide may reflect more than one test arm rather than one fixed product.

The rest of the package is preclinical. In a parallel artificial membrane permeability assay, a lab test that estimates how easily a compound passes through a barrier, the formulation showed up to 6.00 times the permeability of a control, the company said. In a single dose study in beagles, exposure rose up to 6.41 times. The reported material does not name the control or the comparator in the dog work. Gains seen on membranes and in animals often shrink in people, and the human figures here sit at roughly half the beagle number. No protocol, trial registry entry or poster abstract was cited in the report, so every figure in this story rests on the developer's own account and has not been checked by outside reviewers.

How DW5324 stacks up against Rybelsus so far

Rybelsus is the natural yardstick because it is the approved oral form of semaglutide, the same GLP 1 receptor agonist that is also given by injection. Swallowing a peptide is hard. Stomach acid and gut enzymes break peptides down, and the gut wall lets few large molecules through, so only a small share of a swallowed dose usually reaches the blood. Daewon says its in house platform, built on a polymer and lipid complex, shields the peptide in the digestive tract, controls its release and helps it cross the gut lining. The company reported total exposure 1.90 to 3.14 times that of Rybelsus, but it released no data on weight, blood sugar, side effects or tolerability.

The company reported total exposure 1.90 to 3.14 times that of Rybelsus, but it released no data on weight, blood sugar, side effects or tolerability.

Higher exposure is not the same as a better medicine. The common side effects of GLP 1 drugs are digestive and tend to rise with dose, so a formulation that lifts blood levels could also bring more nausea unless the amount in each tablet is cut. Daewon has not said whether it aims for the same blood levels from less drug or for higher levels outright. Spread between people, a common concern with oral peptides, was not reported either. The contrast with Lilly's non peptide pill is useful here, and our orforglipron indirect comparison shows how that tablet is being measured against oral semaglutide. For DW5324 oral semaglutide, the data that matter next are dose finding, tolerability and variability results in people.

Oral peptide delivery and the patent question

Kim Joo-il, vice president and head of the research and development division at Daewon, said the presentation would show the platform "can solve both the patent barrier and the absorption rate limits of oral peptides at the same time." The patent point is commercial as much as scientific. A company that wants to sell an oral semaglutide product may need to avoid patents that cover existing formulations, not only the molecule itself, so a separate delivery system can be a route to market as well as a technical claim. Daewon did not say which patents it has in mind, in which countries, or whether it holds its own filings on the platform. Those details will decide how much the technology is worth to a partner in oral peptide delivery.

Daewon also said it plans licensing talks on the platform with global drug companies and wants to apply it to other biologic medicines. That is a stated plan, not a deal, and no partner has been named. South Korea already has a home grown GLP 1 product, and our efpeglenatide approval story describes how Hanmi reached the market after a domestic phase 3 trial. Daewon is taking a different route. It is not inventing a new molecule but trying to deliver a known one more efficiently. That approach could in theory lean on existing knowledge about semaglutide, but regulators have not said what evidence they would ask for, and the company has not described its intended indication or patient group.

Where DW5324 sits on the board and what comes next

We log DW5324 oral semaglutide at phase 1 with a flat signal and no stage move. People have already received the formulation, which is phase 1 type work, yet the company says its investigational new drug application for a phase 1 trial in Korea is planned for 2027. That suggests the studies shown at AAPS were exploratory, although the report does not say where they ran or under which approval. Daewon also said it will optimize the formulation further after the meeting, so the product that enters a formal trial may differ from the one behind these numbers. Our note on how we weigh stage moves explains why early steps like this one carry little weight on the board.

The checkpoints are concrete. First, a poster or abstract from AAPS PharmSci 360 with methods, amounts, fasting conditions and safety data would let outside scientists judge the exposure claims. Second, the Korean filing planned for 2027 should show the final formulation, the study design and the population. Third, any licensing agreement would show whether larger companies see value in the platform beyond semaglutide. Until those arrive, the frame stays narrow: two small studies, one comparator, one family of blood level measures, all reported by the developer. A strong pharmacokinetic signal is a reason to keep watching a program. It does not tell anyone whether the drug will control blood sugar or weight better than the tablet already on pharmacy shelves.

Conclusion

DW5324 oral semaglutide has an early and interesting exposure story, told so far only by Daewon. Two studies of 18 and 19 people point to higher blood levels than Rybelsus, while safety, efficacy and full methods remain unpublished. The formulation will change before a formal phase 1, now planned in Korea for 2027. This is research reporting, not medical advice.