MFDS Approves Phase 3 Clinical Trial for New Drug Candidate 'DW4421' A P-CAB Class New Drug with Rapid Acid Suppression Focus on the Rapidly Growing Domestic P-CAB Market
Daewon Pharmaceutical announced on the 16th that the clinical phase 3 trial plan (IND, Investigational New Drug: approval procedure for new drug clinical trials) for its next-generation P-CAB (Potassium-Competitive Acid Blocker, a drug group that inhibits gastric acid production by competitively acting with potassium ions in the gastric acid secretion process) candidate 'DW4421' was approved by the Ministry of Food and Drug Safety on the 15th.
'DW4421' (active ingredient: Padoprazan) is a next-generation mechanism P-CAB formulation that rapidly and strongly inhibits gastric acid production by competitively binding with potassium ions to the proton pump (a protein enzyme that helps secrete gastric acid from gastric mucosal cells) at the final stage of gastric acid secretion.
This phase 3 clinical trial aims to evaluate the efficacy and safety profile of DW4421 in patients with erosive gastroesophageal reflux disease (erosive GERD: a condition where the esophageal mucosa is damaged by gastric acid). The study is designed as a randomized, double-blind, active-controlled, parallel, multicenter trial. In Korea, a total of 327 patients will participate across 22 institutions, including Incheon St. Mary's Hospital of The Catholic University of Korea.
Previously, Daewon Pharmaceutical successfully completed a phase 2 clinical trial (Phase 2: clinical stage to verify optimal dosage and initial efficacy) involving 147 patients with erosive GERD. In that trial, DW4421 demonstrated a higher treatment rate in all dosage groups compared to the active comparator (direct comparison target with existing treatments), with excellent tolerability and safety.
According to data from the pharmaceutical market research firm UBIST, domestic P-CAB prescription performance grew rapidly from KRW 30.4 billion in 2019 to KRW 144.9 billion in 2022, and in 2023, it increased by 46% year-on-year to KRW 211.7 billion, reaching KRW 279.2 billion in 2024, establishing itself as a high-growth therapeutic market.
Daewon Pharmaceutical aims to successfully complete this phase 3 trial to commercialize DW4421 and strengthen the competitiveness of domestic new drug technology. A company representative stated, "DW4421 is expected to provide an innovative treatment alternative for patients with gastroesophageal reflux disease. We aim to become a leading company in the domestic P-CAB market."
Kim Sang-jun
AI-translated with ChatGPT. Provided as is; original Korean text prevails.
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