HK InnoN K-Cap's Phase 3 clinical trial to add the 6th indication...Apply for permission from the Ministry of Food and Drug Safety within this year
Oct 22, 2025
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K-Cap's domestic indications are ▲ treatment of erosive gastroesophageal reflux disease ▲ treatment of non-erosive gastroesophageal reflux disease ▲ treatment of gastric ulcers ▲ combination antibiotic therapy for Helicobacter pylori eradication in patients with peptic ulcers and chronic atrophic gastritis ▲ maintenance therapy after treatment of erosive gastroesophageal reflux disease.
This clinical trial was conducted on a total of 392 patients at 33 testing institutions nationwide with random allocation, double blindfolding, and active drug control design to confirm the effect of preventing gastric and duodenal ulcers caused by long-term use of nonsteroidal anti-inflammatory drugs (Non-steroidal Anti-Inflamatory Drugs, hereinafter 'NSAIDs').
After administration of 25 mg of P-CAB-based K-cap tablets (component name Tegoprazan) and 15 mg of PPI-based lansoprazole in patients taking NSAIDs for a long time, we evaluated the effectiveness and safety of 25 mg of K-cap tablets compared to 15 mg of lansoprazole.
As a result of evaluating the incidence (%) of gastric and duodenal ulcers after 24 weeks, the primary effectiveness evaluation variable, the 25 mg K-cap tablet group demonstrated non-inferiority compared to the 15 mg lansoprazole group. In terms of safety, no adverse events related to drugs were observed.
NSAIDs are widely used drugs to treat various pain and inflammatory diseases such as headache, muscle pain, and arthritis. However, long-term use can cause gastrointestinal side effects such as gastritis, gastric ulcer, and gastric bleeding, so it is often used in combination with treatments for gastroesophageal reflux disease.
Based on the clinical results, HKINOEN plans to apply for K-Cap's 6th indication permission to the Ministry of Food and Drug Safety within this year.
This article was translated by Naver AI translator.
