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news.Takeda Pharmaceutical (Takeda) has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare for an acid secretion inhibitor, TAK-438 (generic name: Vonoprazan Fumarate).
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Discovered by Takeda, TAK-438 belongs to a new class of inhibitors called potassium-competitive acid blockers (P-CABs) that show strong and sustainable acid secretion inhibitory effects as well as demonstrate efficacy in early termination by inhibiting the binding of potassium ion (K+) to H+, K+-ATPase (proton pump) in the final step of gastric acid secretion in gastric parietal cells.
The company has also carried out Phase III clinical trials for TAK-438 in Japan for indications such as erosive esophagitis, gastric ulcer, duodenal ulcer, and H. pylori eradication.
In the trial, TAK-438 showed efficacy and has a favorable profile for safety and tolerability.
The new drug application was based on favorable results obtained from these trials.
Currently, proton pump inhibitors (PPIs) are widely prescribed as first-line therapy for the treatment of acid-related diseases in Japan.
The company said that PPIs do not always provide sufficient therapeutic efficacy, and the acid secretion inhibitory effects of PPIs may differ among individuals, because of the protein CYP2C19, which has gene polymorphisms that are involved in metabolism.
TAK-438 inhibits proton pumps without the need for activation by acid and the compound is distributed at high concentrations into the stomach, the target organ, thereby exerting a nearly maximum inhibitory effect from the first dose and remaining effective for 24 hours.
Unlike PPIs, TAK-438 is not primarily metabolized by CYP2C19 which has gene polymorphisms, the company said.
Takeda general manager of Pharmaceutical Development Division Nancy Joseph-Ridge said the company is pleased to submit the NDA for TAK-438, which would represent a new treatment option for patients with acid-related diseases that require inhibition of acid secretion.
"Takeda aims to achieve better treatment outcomes in the field of gastrointestinal diseases and will work hard to meet the medical needs of more patients," Joseph-Ridge said.
Image: Takeda Midosuji Building, headquarters of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o