Onconic Therapeutics Adds Orally Disintegrating Tablet Formulation to P-CAB Drug 'Jakubo'

Second in the World to Develop a P-CAB Orally Disintegrating Tablet

Onconic Therapeutics is expected to see accelerated growth as a new orally disintegrating tablet (ODT) formulation has been added to its P-CAB (potassium-competitive acid blocker) new drug, Jakubo.

On October 31, Onconic Therapeutics announced that it had received domestic New Drug Application (NDA) approval from the Ministry of Food and Drug Safety for the ODT formulation of Jakubo (active ingredient: Zastaprazan), a P-CAB new drug for gastroesophageal reflux disease.

The Jakubo ODT is a new formulation of the 37th new drug Jakubo, which Onconic Therapeutics received approval for and launched in April last year. Aimed at enhancing patient convenience, the company applied for product approval in April this year and obtained approval in about six months.

The ODT formulation is designed to dissolve quickly in the mouth without water, making it ideal for elderly patients who have difficulty swallowing tablets due to impaired esophageal motility, or in situations where immediate administration is needed. Notably, while mint flavor is commonly used in ODTs, it can cause heartburn in patients with gastroesophageal reflux disease. Therefore, an orange flavor was used to improve medication compliance.

With this approval, Onconic Therapeutics has become the second company in the world to offer an ODT formulation among P-CAB treatments for gastroesophageal reflux disease. Having demonstrated rapid development and technical excellence, the company expects this approval to further strengthen Jakubo's global competitiveness.

Jakubo is currently available in 26 countries worldwide. In particular, in China, which is the largest market for gastroesophageal reflux disease, Phase 3 clinical trials have been completed and a product approval application was submitted in August.

A representative from Onconic Therapeutics stated, "With the approval of the ODT formulation, our product lineup is expanding, and we expect Jakubo's growth to accelerate further. Diversifying formulations is a meaningful achievement, as it allows us to provide more tailored treatment options for patients. We will continue to prove our competitiveness in the global P-CAB market, which is valued at 40 trillion won, and leverage our experience in growing Jakubo into a blockbuster to speed up the development of our subsequent pipeline."

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