CJ Healthcare said Tuesday that it has published a phase 3 clinical trial for K-CAB (Ingredient: tegoprazan), a gastroesophageal reflux disease (GORD) treatment, in an international journal.
|CJ Healthcare headquarters in Myeongdong, Seoul.|
K-CAB is Korea’s 30th novel drug, which won the license in July 2018. It became the first potassium-competitive acid blocker (P-CAB) to obtain the indication for erosive and non-erosive GORD in Korea.
While conventional treatments such as proton pump inhibitors (PPI) need three to five days to show efficacy, P-CAB drugs suppress gastric acid secretion within one hour after taking the medication. P-CAB treatments also suppress excessive secretion of gastric acid during night time, which could reduce chest pain and a sleep disorder, according to CJ HealthCare.
The phase 3 clinical trials compared the efficacy and safety of K-CAB with those of Esomeprazole, a proton-pump inhibitor system that is the most common treatment for patients suffering from GORD.
The company randomly assigned 302 patients diagnosed with GORD in the internal mammary gland with either 50 mg of tegoprazan, 100 mg of tegoprazan, or 40 mg of Esomeprazole for eight weeks.
“As the third phase clinical trial of K-CAB was listed in a prestigious foreign medical journal, the efficacy and safety of the product were recognized worldwide,” said Professor Lee Kwang-jae from Ajou University School of Medicine and the lead researcher for the trial.
Alimentary Pharmacology & Therapeutics published the results of the study.