Onconic Therapeutics has checked off a critical milestone in its push to expand Jaqbo, hitting bioequivalence targets for an orally disintegrating tablet (ODT) formulation of the acid reflux med.
The Jeil Pharma subsidiary said Wednesday that the new ODT version of zestaprazan citrate met Korea’s 80–125 percent bioequivalence range for both Area Under the Curve (AUC) to time and maximum concentration in a phase 1 crossover trial, putting it on track for a domestic label expansion and teeing up global commercialization efforts.
With the bioequivalence bar cleared, Onconic is now positioned as the only second drugmaker globally—after local rival HK inno.N—to bring a P-CAB-based ODT to market.
Onconic Therapeutics has achieved bioequivalence for its orally disintegrating tablet formulation of Jaqbo (zestaprazan).
Onconic Therapeutics has achieved bioequivalence for its orally disintegrating tablet formulation of Jaqbo (zestaprazan).
The reformulation isn’t just about convenience. Standard mint-flavored ODTs can aggravate GERD symptoms, according to Onconic. So the biotech reworked the pill with a smoother, orange-flavored profile and smaller size to improve patient comfort and boost adherence—a calculated move in Korea, which led the global peptic ulcer drug market with over 175 billion won in annual prescriptions last year alone.
Conducted at H+ Yangji Hospital in Seoul, the six-arm, three-period trial enrolled 54 healthy adults and compared three versions of Jaqbo: ODT taken without water, a conventional tablet taken with 150 mL of water, and a reference drug. Plasma levels were tracked over 36 hours across 20 time points. The trial wrapped on April 2 and will support Onconic’s new drug application to the Ministry of Food and Drug Safety.
Jaqbo was approved last year as Korea’s 37th novel drug and hit the domestic market in October. A phase 3 trial for a gastric ulcer indication was completed in January, and Onconic has submitted for a label expansion based on those data. Outside Korea, the company is using the domestic approval package to seek clinical trial exemptions and accelerate registration in Southeast Asia, Mexico, and South America.
The ODT formulation is part of a broader global push. In 2023, Onconic handed Greater China rights to Chinese pharma Livzon in a deal worth up to $127.5 million. The company is now advancing zestaprazan in parallel trials, with a phase 3 underway for the oral version and a phase 1 for the injectable.
Beyond acid reflux, Onconic is also building out its oncology pipeline. The company recently snagged an FDA orphan drug designation for Nesuparib, a synthetic lethality-based PARP inhibitor in development for gastric and gastroesophageal junction cancers.
Related articles
Jeil Pharmaceutical names founder’s grandson as co-CEO
Onconic Therapeutics claims additional milestone payment from Chinese partner for GERD drug technology transfer
Onconic Therapeutics’ nesuparib scores FDA orphan drug designation for gastric cancer
New GERD drug Jaqbo wins grand prize in the Korean New Drug Development Award
Takeda’s market exit and return of vonoprazan raise stakes in Korea’s drug pricing battle
Onconic Therapeutics seeks new gastric ulcer indication approval for its P-CAB drug
Jeil Pharm's Jaqbo falls short in Korea’s booming P-CAB market with weak 1st-month sales
Onconic Therapeutics passes preliminary Kosdaq IPO review
Kim Ji-hye jkim404@docdocdoc.co.kr
See Other Articles
Copyright © KBR Unauthorized reproduction, redistribution prohibited