Onconic Therapeutics Applies for New Drug Approval for Gastroesophageal Reflux Disease

P-CAB Class New Drug 'Jastaprajan'
Aiming for Launch Next Year

Onconic Therapeutics announced on the 7th that it has submitted a New Drug Application (NDA) for the domestic launch of the gastroesophageal reflux disease (GERD) new drug 'Jastaprazan' to the Ministry of Food and Drug Safety.

Exterior view of Onconic Therapeutics Research Institute.
[Photo by Onconic Therapeutics]

Jastaprazan is a GERD new drug candidate developed by Onconic Therapeutics, belonging to the potassium-competitive acid blocker (P-CAB) class, which reversibly inhibits the proton pumps that secrete gastric acid. It offers advantages such as faster onset of action compared to existing proton pump inhibitor (PPI) products and can be taken regardless of meals.

This new drug application was based on the results of a Phase 3 clinical trial conducted at 28 medical institutions in Korea involving 298 GERD patients. The clinical trial compared the efficacy and safety of Jastaprazan 20 mg and Esomeprazole 40 mg administered for 4 and 8 weeks in patients with erosive esophagitis. The study was conducted using objective methods such as randomized allocation and double-blinding to demonstrate non-inferiority to the PPI-class Esomeprazole. According to the company, the clinical results confirmed Jastaprazan’s superior mucosal defect healing effect and safety.

Onconic Therapeutics expects to launch the new drug in 2024 if the review process proceeds smoothly. A representative from Onconic Therapeutics stated, "P-CAB formulations are next-generation drugs that improve on the shortcomings of existing PPI formulations, and the domestic market landscape is already changing. Although we are a startup focused on new drug research and development, it is very meaningful that we have proven our new drug development capabilities through successful clinical results and are now able to challenge new drug approval."

Onconic Therapeutics plans to expand its global market entry, including the United States and Europe, along with additional indications for Jastaprazan currently underway.

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