HK Innoen Succeeds in Phase 3 Clinical Trial for Sixth Indication of New Drug K-Cab

Proven Preventive Effect Against Gastric and Duodenal Ulcers
During Long-Term Use of Non-Steroidal Anti-Inflammatory Drugs

HK Innoen has successfully completed Phase 3 clinical trials for the sixth indication of its new gastroesophageal reflux disease drug, K-Cab. This clinical trial was conducted to confirm the preventive effect of K-Cab against gastric and duodenal ulcers caused by long-term use of non-steroidal anti-inflammatory drugs (NSAIDs). HK Innoen plans to apply for approval of this new indication to the Ministry of Food and Drug Safety within this year.

On October 22, HK Innoen announced that it had recently completed Phase 3 clinical trials to add a new indication for K-Cab (active ingredient: tegoprazan).

HK Innoen Gastroesophageal Reflux Disease New Drug K-Cab Series. HK Innoen

This clinical trial was a randomized, double-blind, active-controlled study conducted at 33 medical institutions nationwide, involving a total of 392 patients. The purpose was to confirm the preventive effect of K-Cab against gastric and duodenal ulcers induced by long-term NSAID use.

In this study, patients taking NSAIDs long-term were administered 25 mg of K-Cab tablet (a potassium-competitive acid blocker, or P-CAB) and 15 mg of lansoprazole (a proton pump inhibitor, or PPI). The preventive effect and safety of 25 mg K-Cab compared to 15 mg lansoprazole for gastric and duodenal ulcers were evaluated.

According to the results of the primary efficacy endpoint, which was the incidence rate (%) of gastric and duodenal ulcers after 24 weeks, the group administered 25 mg K-Cab was proven to be non-inferior to the group administered 15 mg lansoprazole. In terms of safety, no drug-related adverse events of concern were observed.

NSAIDs are widely used to treat various types of pain and inflammatory diseases, such as headaches, muscle pain, and arthritis. However, long-term use can cause gastrointestinal side effects, including gastritis, gastric ulcers, and gastrointestinal bleeding, which is why they are often used in combination with gastroesophageal reflux disease treatments.

Based on the results of this clinical trial, HK Innoen plans to apply for approval of the sixth indication for K-Cab to the Ministry of Food and Drug Safety within this year.

K-Cab, the 30th new drug developed in South Korea, has held the top spot in outpatient prescriptions for peptic ulcer medications in the country since its launch in March 2019, thanks to its rapid onset of action and proven safety for long-term use over six months.

The domestic indications for K-Cab include: 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/or chronic atrophic gastritis, and maintenance therapy after treatment of erosive gastroesophageal reflux disease. With a total of five indications, K-Cab holds the most indications among P-CAB class gastroesophageal reflux disease treatments.

Currently, HK Innoen has signed technology transfer or finished product export contracts with 53 countries abroad, and the drug has been launched in 18 countries, including South Korea, China, and countries in Central and South America, further expanding its presence in the global market.

This content was produced with the assistance of AI translation services.