Daewon Pharmaceutical (003220.KS) is accelerating its push into the digestive disease treatment market with Fadoprazan (DW-4421), a new drug candidate in the potassium-competitive acid blocker (P-CAB) class. The company's strategy is to differentiate the drug as a treatment patients can take comfortably over long periods, drawing on formulation technology it has built up developing incrementally modified drugs.
Daewon Pharmaceutical has completed patient enrollment for its Phase 3 trial of Fadoprazan in erosive gastroesophageal reflux disease (ERD) and is preparing to secure topline data, according to the pharmaceutical industry on the 22nd. A Phase 3 trial in non-erosive gastroesophageal reflux disease (NERD) is also under way at 29 medical institutions nationwide. The company plans to obtain Phase 3 topline results in November and submit a new drug application to the Ministry of Food and Drug Safety in December. ERD refers to cases in which an endoscopy shows the esophageal lining has actually eroded or been damaged. NERD refers to cases in which patients have symptoms such as heartburn but an endoscopy shows no clear damage to the lining.
Fadoprazan is a P-CAB new drug candidate that Daewon Pharmaceutical is developing as a next-generation growth driver. Annual prescription sales in the domestic P-CAB market have surpassed 370 billion won ($266 million). Daewon Pharmaceutical intends to set Fadoprazan apart as a treatment suited to dosing convenience and long-term administration.
The clearest example of that strategy is tablet miniaturization. In a recent clinical study of a smaller Fadoprazan formulation, the company confirmed equivalence with the existing formulation on key pharmacokinetic measures including peak blood concentration and absorption rate. The pill was made smaller while its behavior in the body was preserved.
Daewon Pharmaceutical has accumulated tablet miniaturization technology across a range of treatments. Uptava sustained-release tablets, a dyslipidemia treatment, cut volume by about 43% compared with the previous capsule. Tizifenone tablets, a treatment for hypertriglyceridemia, reduced tablet size to the smallest among products with the same ingredient and rose to the top of the market for that ingredient.
The approach also aligns with an environment in which more patients take multiple medications at once as the population ages. According to the Health Insurance Review and Assessment Service, the number of people treated for gastroesophageal reflux disease in Korea has passed 4.9 million a year, with patients in their 50s and those 60 and older accounting for about half. Older patients often take treatments for several chronic conditions together, so pill size and ease of dosing affect medication adherence.
Fadoprazan is also focused on dose selection designed for long-term use. In a Phase 2 trial in patients with erosive gastroesophageal reflux disease, Daewon Pharmaceutical confirmed healing of mucosal defects and good tolerability at both 20 mg and 40 mg.
Sustained acid suppression is another key development point. In treating gastroesophageal reflux disease, a central measure is how steadily gastric pH can be held above 4. Fadoprazan raised gastric pH above 4 quickly from the first dose and showed stable control of pH fluctuation over 24 hours.
Fadoprazan is seen as an example of Daewon Pharmaceutical's open innovation strategy. The company formally joined development in May 2024 by signing a joint development agreement for Fadoprazan with drug developer Unovia. In July of that year, the clinical trial sponsor changed from Unovia to Daewon Pharmaceutical, handing the company the lead on development. Daewon Pharmaceutical has since driven late-stage trials, formulation optimization and approval preparations to speed commercialization. Following gastroesophageal reflux disease, the company plans to expand indications to the prevention of peptic ulcers associated with nonsteroidal anti-inflammatory drug use and to Helicobacter pylori eradication therapy.
"Fadoprazan, the second new drug that will drive Daewon Pharmaceutical's future growth, has moved a step closer to commercialization as its Phase 3 trials proceed smoothly," said Baek In-hwan, president of Daewon Pharmaceutical. "Based on differentiated formulation competitiveness, we will lead the fast-growing P-CAB market and offer better treatment options to patients with digestive diseases."
