Onconic Therapeutics' Zacube Begins Phase 3 Trial for Helicobacter Eradication Therapy

Phase 3 IND Approved by MFDS
P-CAB Recommended as First-Line Eradication Therapy
Quadruple Therapy Under Evaluation in China

Zacube, which has been showing an upward trend in the domestic gastrointestinal ulcer treatment market, has established a new foothold for additional indication expansion.

On September 3, Onconic Therapeutics announced that it received approval from the Ministry of Food and Drug Safety for a phase 3 clinical trial plan (IND) to obtain a new indication for eradication therapy of Helicobacter pylori for its P-CAB class treatment, ‘Zacube’ (ingredient name: Zastaprazan), which is the 37th domestically developed new drug.

This clinical trial is intended to expand Zacube's indications beyond gastroesophageal reflux disease and gastric ulcer to include eradication therapy for Helicobacter pylori. If the clinical trial is successful and the indication is added, Zacube’s scope of prescription will extend from managing gastric acid-related diseases to eradication therapy targeting the underlying bacterium.

The clinical trial will enroll 414 Helicobacter pylori-positive patients and take place at 24 institutions within Korea. The study will compare the efficacy and safety of Zacube-based triple therapy (Zacube, amoxicillin, and clarithromycin) with the conventional lansoprazole-based triple therapy. Patients will receive medication twice daily for two weeks, and eradication will be confirmed at least four weeks after discontinuation of the therapy.

Helicobacter pylori is a major causative bacterium of gastritis and peptic ulcer, and is also associated with an increased risk of gastric cancer. According to the "2025 Revised Clinical Practice Guidelines for Evidence-Based Diagnosis and Treatment of Helicobacter pylori in Korean Patients" by the Korean Society of Upper Gastrointestinal Diseases & Helicobacter pylori, the infection rate of Helicobacter pylori in Korea is reported to be around 50%.

In particular, these guidelines recommend P-CAB-based combination antibiotic therapy as a first-line eradication treatment that can replace conventional PPI-based therapy. Accordingly, the center of eradication therapy is expected to shift from conventional PPIs to P-CABs.

The development of eradication therapy for Zacube is also underway overseas. In China, partner company Livzon Pharmaceutical began enrolling patients and administering the first dose in May for a phase 3 trial. Livzon is evaluating a quadruple therapy regimen using Zastaprazan (Zacube), amoxicillin, clarithromycin, and bismuth in line with China's standard therapy. While a triple therapy is being evaluated in Korea, a quadruple therapy matching the local standard is under investigation in China, and the strategy is to strengthen Zacube’s competitiveness in the global Helicobacter pylori eradication market, where the potential patient pool is large.

Currently, Zacube is approved for erosive gastroesophageal reflux disease and gastric ulcer. Phase 3 clinical trials are ongoing for expanded indications, including Helicobacter pylori eradication therapy, non-erosive gastroesophageal reflux disease, maintenance therapy after treating erosive gastroesophageal reflux disease, and prevention of NSAID-induced peptic ulcers.

An official from Onconic Therapeutics said, “This phase 3 approval is an important step for Zacube to expand its treatment area from conventional gastric acid-related diseases into the large Helicobacter pylori eradication market,” adding, “As we are simultaneously conducting phase 3 eradication therapy trials in Korea and China, we will continue to expand Zacube's indications and strengthen its competitiveness in the global eradication therapy market.”

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