HK inno.N, formerly known as CJ Healthcare, said that the U.S. Food and Drug Administration has approved its phase 1 clinical trial of K-Cab (Ingredient: tegoprazan), a gastroesophageal reflux disease (GORD) treatment.
|HK inno.N's K-Cab, a treatment for the gastroesophageal reflux disease|
K-Cab became Korea's 30th novel drug in 2018. It is the first potassium-competitive acid blocker (P-CAB) to obtain the indication for erosive and non-erosive GORD in Korea. The company started marketing the drug in the domestic market in March last year.
While conventional treatments, such as proton pump inhibitors (PPI), need three to five days to show efficacy, P-CAB drugs suppress gastric acid secretion in just one hour, according to the company. P-CAB treatments also inhibit excessive secretion of gastric acid during night time, reducing chest pain and a sleep disorder, it said.
HK inno.N said it plans to evaluate the safety, tolerability, and pharmacokinetics of the drug on healthy American adults.
"K-Cap has created a new treatment trend as a new drug for the GORD in the local market. We expect the drug will show the potential of Korean drugs through successful research in the U.S.," a company official said.