Onconick Therapeutics (476060.KQ) is launching a maintenance therapy clinical trial for its gastroesophageal reflux disease (GERD) treatment Jaqbo, aiming to extend prescription duration. The strategy seeks to move beyond acute-phase treatment to encompass relapse management, securing a foundation for long-term prescriptions.
Onconick Therapeutics said Thursday it filed an Investigational New Drug (IND) application for a Phase 3 clinical trial with the Ministry of Food and Drug Safety (MFDS) to obtain a "maintenance therapy after treatment of erosive GERD" indication for Jaqbo (ingredient name: zastaprazan).
The trial aims to secure a maintenance therapy indication that suppresses symptom recurrence after treatment. GERD is a representative chronic relapsing disease, with symptoms recurring in a significant number of patients once treatment is discontinued. Major treatment guidelines have emphasized the need for long-term maintenance therapy for this reason.
The trial is designed based on a low dose of 10mg, half the existing treatment dose of 20mg. The core objective is to evaluate efficacy and safety in a long-term administration setting of up to six months. Upon completion, Jaqbo will expand its scope from short-term symptom treatment to post-treatment relapse management.
Jaqbo, Korea's 37th domestically developed new drug, received approval as an erosive GERD treatment in 2024 and added a gastric ulcer indication in 2025. Phase 3 trials are currently underway for nonsteroidal anti-inflammatory drug (NSAID)-induced ulcer prevention and non-erosive reflux disease (NERD) indications, respectively. The company also launched an orally disintegrating tablet (ODT) formulation in January this year, enhancing medication convenience.
Onconick Therapeutics is rapidly executing a "lineup strategy" by simultaneously expanding Jaqbo's indications and formulations. The company's R&D-centered organizational structure is cited as a strength, enabling fast decision-making on follow-up trials and indication expansion.
Global expansion is also materializing. Chinese partner Livzon filed a marketing authorization application for Jaqbo with China's National Medical Products Administration (NMPA) in August last year, and Onconick Therapeutics received a milestone payment accordingly. The move targets China's GERD market, estimated at approximately 6 trillion won ($4.4 billion).
The maintenance therapy trial is also considered significant in that it can generate data applicable to global regulatory approval and commercialization processes, beyond domestic indication expansion. "The maintenance therapy trial is an opportunity to significantly expand Jaqbo's market in terms of prescription duration and dosage," an Onconick Therapeutics official said. "Based on our domestic commercialization experience, we will enhance global scalability and accelerate the development of follow-up oncology pipelines."