Onconic Therapeutics' Zacubo Enters Phase 3 Trial for Helicobacter pylori Eradication Therapy

[Financial News] Onconic Therapeutics' acid-suppressing drug Zacubo is seeking to expand its indications to include Helicobacter pylori eradication therapy.
Onconic Therapeutics announced on the 3rd that it had received approval from the Ministry of Food and Drug Safety for the investigational new drug application for a Phase 3 trial to secure an indication for Helicobacter pylori eradication therapy using Zacubo, the 37th domestically developed new drug and a P-CAB-class treatment whose active ingredient is Zastaprazan.
The trial is intended to expand Zacubo's current use in treating gastroesophageal reflux disease and gastric ulcers to include Helicobacter pylori eradication therapy. If the trial succeeds and the new indication is added, Zacubo could be used not only for acid-related diseases but also to eliminate Helicobacter pylori, a cause of conditions including gastric ulcers.
The trial will be conducted at 24 institutions in South Korea involving 414 Helicobacter pylori-positive patients. It will compare the efficacy and safety of triple therapy combining Zacubo, amoxicillin, and clarithromycin with the existing lansoprazole-based triple therapy.
Patients will receive the medications twice daily for two weeks. Helicobacter pylori eradication will be assessed at least four weeks after the end of treatment.
Helicobacter pylori is a major bacterium that causes gastritis and peptic ulcers and is also associated with the risk of developing gastric cancer. According to the Korean College of Helicobacter and Upper Gastrointestinal Research, the infection rate in South Korea is estimated at around 50%.
Recently, eradication therapy using P-CAB-class drugs instead of conventional proton pump inhibitors (PPIs) has also been expanding. P-CABs are considered advantageous because they suppress gastric acid more quickly and strongly, creating a gastric environment more suitable for antibiotics to work. In its revised 2025 treatment guidelines, the association also recommends P-CAB-based antibiotic combination therapy as a first-line eradication treatment option.
Development of Zacubo-based Helicobacter pylori eradication therapy is also underway overseas. In China, a Phase 3 trial began after the first patient received treatment in May through local partner Livzon Pharmaceutical.
The Chinese trial is evaluating quadruple therapy combining Zastaprazan, amoxicillin, clarithromycin, and bismuth in line with local treatment standards. Helicobacter pylori infection rates in China are also reportedly above 40%, and the company expects this to provide access to a substantial patient population.
An Onconic Therapeutics representative said, "The approval of this Phase 3 trial marks an important step toward expanding Zacubo's treatment scope to include Helicobacter pylori eradication therapy." The representative added, "We will pursue Phase 3 eradication therapy trials simultaneously in South Korea and China to secure additional indications and strengthen our competitiveness in the global market."
[email protected] Sang-hee Jung Reporter