Daewoong Pharmaceutical said on the 1st it launched P-CAB class gastrointestinal drug Pexuclu 20 mg (ingredient name fexuprazan hydrochloride), the first in Korea to be officially recognized for preventing peptic ulcers in patients who take nonsteroidal anti-inflammatory drugs (NSAIDs) long term.
The new product offers an option to prevent gastrointestinal disorders for patients who need to take NSAIDs for an extended period. Pexuclu quickly suppresses gastric acid secretion, and with once-daily dosing regardless of meals, its effects last a long time, making it highly convenient.
According to the company, its efficacy and safety were confirmed in a recent domestic multicenter phase 3 clinical study. The study enrolled 423 adults who take NSAIDs long term and compared Pexuclu 20 mg with the existing therapy lansoprazole 15 mg over 24 weeks. Endoscopic results showed gastric ulcer incidence rates of 1.16% and 2.76%, respectively, demonstrating that Pexuclu was not inferior to the existing drug. The incidence of adverse events also showed no significant difference between the two groups.
It was noted that concomitant use with anti-inflammatory analgesics maintained the drug's effect in a phase 1 study. In 111 healthy adults, coadministration with NSAIDs such as naproxen and meloxicam showed no changes in drug concentration or action, and no dose adjustment was necessary.
With this 20 mg launch, Pexuclu now comes in 40 mg, 20 mg and 10 mg, establishing the most diverse lineup among P-CABs. In addition to treating gastroesophageal reflux disease and acute and chronic gastritis, it expanded its efficacy to include prevention of NSAID-induced peptic ulcers. Daewoong Pharmaceutical is also conducting additional studies such as eradication of Helicobacter pylori.
Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, "We will expand indications through future clinical studies and continue research and development to bolster competitiveness in the global market."