Published in the International Journal DDDT

Onconic Therapeutics has obtained clinical evidence that its gastroesophageal reflux disease (GERD) treatment Zaqbo (active ingredient: zastaprazan citrate) can be used with dyslipidemia medications. The findings are expected to serve as a reference for co-prescribing in clinical settings, where many patients take both acid-suppressing drugs and cardiovascular medications.

Graph comparing changes in blood drug concentrations over time following administration of Zaqbo (zastaprazan) and atorvastatin alone and in combination. From top: blood concentration changes for zastaprazan (A), atorvastatin (B), and 2-hydroxyatorvastatin (C), an active metabolite of atorvastatin. Onconic Therapeutics

Graph comparing changes in blood drug concentrations over time following administration of Zaqbo (zastaprazan) and atorvastatin alone and in combination. From top: blood concentration changes for zastaprazan (A), atorvastatin (B), and 2-hydroxyatorvastatin (C), an active metabolite of atorvastatin. Onconic Therapeutics

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On October 21, Onconic Therapeutics said that when Zaqbo and the dyslipidemia medication atorvastatin were administered together, atorvastatin's peak plasma concentration and total exposure in the body were 98% and 103% of the levels seen with atorvastatin alone, respectively. This means Zaqbo had no meaningful effect on atorvastatin exposure in the body. The findings were published in the international journal Drug Design, Development and Therapy (DDDT).


The study was conducted by a research team led by Professor Shin Wonseok of the Department of Clinical Pharmacology at CHA University Bundang CHA Hospital, and involved 24 healthy Korean adults. The researchers compared blood concentrations after administering atorvastatin 40 mg, Zaqbo 20 mg, and then the two drugs in combination, each once daily for five days. They assessed interactions in both directions under steady-state conditions, in which drug concentrations in the body had stabilized, as in an actual prescribing setting.


Concentrations of atorvastatin's active metabolite did not increase, and Zaqbo's total exposure in the body also remained similar to that seen when taken alone. Most adverse events were mild, and all resolved. There were no serious adverse events or withdrawals due to adverse events.


In the paper, the researchers said, "These results suggest that atorvastatin dose adjustment is not necessary under the conditions of this study." They added, "Given that different interaction profiles with atorvastatin have been reported among existing potassium-competitive acid blockers (P-CABs), interactions between P-CABs and statins may vary according to the properties of individual drugs rather than being a shared class effect."



An Onconic Therapeutics official said, "Many patients with gastroesophageal reflux disease also take several medications for chronic conditions such as dyslipidemia." The official added, "This study is significant because it provides pharmacokinetic evidence that healthcare professionals can refer to when co-prescribing two drugs that are commonly prescribed in Korea."


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