Daewon Pharmaceutical succeeds in Phase 3 trial of new GERD drug, plans to seek marketing approval

[Financial News] Padoprazan (DW4421), a novel drug candidate being developed by Daewon Pharmaceutical to treat gastroesophageal reflux disease (GERD), met key endpoints in a Phase 3 clinical trial in South Korea. Having demonstrated noninferiority to existing treatments, the company plans to apply for marketing approval this year.
Daewon Pharmaceutical said on the 29th that padoprazan met the primary efficacy endpoint in a Phase 3 clinical trial involving 328 patients with erosive gastroesophageal reflux disease.
The trial was conducted at 22 medical institutions in South Korea and compared groups receiving 20 mg or 40 mg of padoprazan with a group receiving 40 mg of esomeprazole, an existing treatment in the proton pump inhibitor (PPI) class. In an endoscopic assessment of whether esophageal mucosal breaks had completely healed, both doses met the prespecified noninferiority criteria.
In a per-protocol analysis, the 95% confidence interval for the difference in efficacy rates versus the control group was -2.50% to 6.87% for the 40-mg padoprazan group and -3.90% to 6.58% for the 20-mg group. In both groups, the lower bound of the confidence interval was above the noninferiority threshold of -10%.
Safety was also found to be comparable to that of the control drug. Adverse drug reaction rates were 4.59% in the 40-mg padoprazan group, 3.74% in the 20-mg group, and 3.70% in the esomeprazole group. There were no statistically significant differences among the treatment groups, and no serious adverse events occurred.
After completing a detailed analysis, Daewon Pharmaceutical plans to submit the final clinical trial report to the Ministry of Food and Drug Safety and apply for marketing approval this year. A Phase 3 trial in patients with non-erosive gastroesophageal reflux disease (NERD) is also underway, and the company is preparing clinical trials to secure additional indications.
Padoprazan is a novel drug candidate in the potassium-competitive acid blocker (P-CAB) class. It suppresses gastric acid secretion through a mechanism different from that of conventional PPIs. As South Korea's P-CAB market grows, approval of padoprazan is expected to have an impact on the expansion of Daewon Pharmaceutical's GERD treatment business. According to UBIST, a pharmaceutical market research firm, outpatient prescription sales of P-CAB drugs in South Korea totaled 368.6 billion won in 2025, up about 29% from the previous year. Annual prescription sales are expected to exceed 400 billion won this year.

[email protected] Sang-hee Jung Reporter