HK inno.N

HK inno.N Presents Clinical Results of Novel GERD Drug ‘K-CAB’ for H. pylori Eradication at UEGW

Comparison of Dose-Specific Standard Triple Therapy with K-CAB and Lansoprazole for 14-Day H. pylori Eradication

K-CAB Achieves Over 80% Eradication Rates Across All Dose Groups, Demonstrating Superior Therapeutic Efficacy

K-CAB Highlights Potential as a PPI Replacement for First-Line H. pylori Eradication Therapy

Photo. The research team presents the clinical results of K-CAB for Helicobacter pylori eradication at the 2025 United European Gastroenterology Week (UEGW). 

HK inno.N unveiled the clinical trial results of “K-CAB (active ingredient: tegoprazan),” its novel drug for gastroesophageal reflux disease (GERD), demonstrating new possibilities to replace conventional proton pump inhibitors (PPIs) for Helicobacter pylori eradication. The findings were presented at the “2025 United European Gastroenterology Week (UEGW),” Europe’s largest gastroenterology conference, held in Berlin, Germany, from October 4 to 7 (local time).

The clinical trial involved 382 H. pylori-positive patients in Korea to evaluate the safety and efficacy of standard triple therapy including K-CAB tablets (tegoprazan), a drug of the P-CAB class, (tegoprazan, amoxicillin, and clarithromycin), compared to the conventional standard triple therapy with lansoprazole, a PPI-class drug, (lansoprazole, amoxicillin, and clarithromycin), administered for 14 days.

The clinical results revealed that the eradication rates in the K-CAB Tab. 50 mg and 100 mg treatment groups were 85.95% and 85.48%, respectively, surpassing the 78.74% eradication rate observed in the lansoprazole 30 mg treatment group, thereby demonstrating the non-inferiority of K-CAB (mITT analysis set). Notably, K-CAB achieved eradication rates exceeding 80% across all dose groups, reinforcing its potential as a first-line treatment for H. pylori eradication.

Currently, the standard triple therapy for H. pylori eradication involves a standard dose of a PPI drug combined with 1 g of amoxicillin and 500 mg of clarithromycin, administered twice daily. According to the “Revised Evidence-Based Guidelines for the Treatment of Helicobacter pylori Infection in Korea (2020),” an eradication rate of at least 80% is recommended for first-line treatment.

In addition to the Korean clinical trial results, findings from global, investigator-initiated clinical trials of K-CAB conducted in Latin America were also presented at the conference. As Latin America is one of the key overseas markets for K-CAB, HK inno.N plans to accelerate its market expansion based on accumulated local data.

“The clinical results underscore K-CAB’s capability to replace conventional PPI-based drugs as a first-line treatment for Helicobacter pylori eradication,” an HK inno.N representative commented. “We are committed to further research to strengthen K-CAB’s position in both domestic and global markets.”

K-CAB, Korea’s 30th novel drug, has achieved cumulative domestic prescription sales of KRW 810.1 billion since its launch in March 2019 through the first half of 2025. With features such as △ rapid action after administration and △ safety demonstrated even after long-term use for up to six months, K-CAB has ranked No. 1 in domestic outpatient prescription sales for peptic ulcer treatment. The drug is approved in Korea for five indications: △ erosive gastroesophageal reflux disease, △ non-erosive gastroesophageal reflux disease, △ gastric ulcer, △ antibiotic combination therapy to eradicate Helicobacter pylori in patients with peptic ulcer and/or chronic atrophic gastritis, and △ maintenance therapy after treatment of erosive gastroesophageal reflux disease. HK inno.N has entered into agreements for the export of technology or the finished product with 53 countries and has launched K-CAB in 18 countries, including South Korea, China, and Latin America, further expanding its global presence. (The End)

Reference Information

P-CAB (Potassium Competitive Acid Blocker / HK inno.N K-CAB (Tegoprazan))

P-CAB works by directly binding to the potassium ions of the proton pump, without requiring activation by gastric acid. This mechanism prevents the binding of potassium ions to the proton pump, thereby inhibiting gastric acid secretion.

As a result, P-CAB can be taken regardless of food intake, delivering rapid and potent gastric acid suppression from the first day of administration. Additionally, its long-lasting effects surpass PPIs in controlling nocturnal acid secretion.

PPI (Proton Pump Inhibitor / lansoprazole, etc.)

PPIs irreversibly inhibit the gastric proton pump (Hydrogen/Potassium Adenosine Triphosphatase; H+/K+-ATPase), which is responsible for the final step of gastric acid secretion.

PPIs are prodrugs that require activation by gastric acid before binding to the proton pump to inhibit gastric acid secretion. Consequently, they must be taken before meals, and their maximum effect is typically achieved after 3 to 5 days of consecutive administration.

UEGW: United European Gastroenterology Week

Source of the standard triple therapy for Helicobacter pylori eradication

Revised Evidence-Based Guidelines for the Treatment of Helicobacter pylori Infection in Korea (2020) (https://doi.org/10.3904/kjm.2021.96.3.160), published in The Korean Journal of Internal Medicine: Volume 96, Issue 3 (2021).

Title of the clinical trial in Korea

A Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan-Based Standard Triple Therapy for Helicobacter pylori Eradication

Titles of the investigator-initiated clinical trials in Latin America

- Near-Complete Eradication of Helicobacter pylori in a Latin American Cohort Using Limecycline–Tegoprazan-Based Quadruple Therapy: Overcoming Antibiotic Resistance in Real-World Settings

- Non-Inferiority Trial Comparing Tegoprazan and Esomeprazole for Helicobacter pylori Eradication in Treatment-Naive Latin American Patients

K-CAB has been launched in the following 18 markets (out of 54 entered markets including South Korea)

▲South Korea

▲China (Country to which technology has been exported)

▲Mongolia, Philippines, Mexico, Indonesia, Singapore, Peru, Chile, Colombia, Dominican Republic, Nicaragua, Honduras, Guatemala, El Salvador, Panama, India, and Malaysia (16 countries to which the finished product has been exported)