Daewoong Pharmaceutical Launches 'Pexuclu 20mg'... Prevents Gastric Ulcers in Long-term NSAID Users

Targeting the Global Gastrointestinal Therapeutics Market

On December 1, Daewoong Pharmaceutical announced the domestic launch of 'Pexuclu 20mg (active ingredient: fexuprazan hydrochloride),' a P-CAB class gastrointestinal medication. This is the first drug in Korea to be officially recognized for its efficacy in preventing peptic ulcers (lesions in the stomach and upper duodenum) that may occur in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) long-term.

Pexuclu 20mg. Daewoong Pharmaceutical

With the official recognition of Pexuclu 20mg’s efficacy in the 'prevention of NSAID-induced ulcers,' it has become the first P-CAB class product in Korea to enter this field. This marks a significant change, as it broadens the scope of use for new drugs developed with domestic technology. Given that anti-inflammatory analgesics are widely used worldwide, this is also expected to strengthen Pexuclu’s global competitiveness.

The newly launched Pexuclu 20mg offers a new preventive option for patients concerned about gastrointestinal issues while taking anti-inflammatory analgesics for extended periods. The product significantly enhances patient convenience by rapidly suppressing gastric acid secretion, allowing administration regardless of meals, and maintaining long-lasting effects with just once-daily dosing.

The efficacy and safety of Pexuclu 20mg were confirmed in a recently published domestic multicenter Phase 3 clinical trial (Gut Liver, 2025). In this study, 423 adults who needed continuous NSAID therapy were administered either fexuprazan 20mg or the existing treatment lansoprazole 15mg for 24 weeks. The incidence of endoscopically confirmed gastric ulcers was 1.16% and 2.76%, respectively, demonstrating that Pexuclu met the non-inferiority criteria compared to the existing drug. The incidence of adverse events was also similar between the two groups.

With the launch of the 20mg dose, Pexuclu now offers a full range of 40mg, 20mg, and 10mg formulations, making it the P-CAB class product with the most diverse lineup. In addition to its existing indications for erosive reflux esophagitis and acute and chronic gastritis, its efficacy has now been expanded to include the prevention of NSAID-induced peptic ulcers.

Lee Changjae, CEO of Daewoong Pharmaceutical, stated, "Pexuclu 20mg is the first product in Korea to be approved for the prevention of ulcers in patients taking anti-inflammatory analgesics, and it is highly meaningful in that it offers a new treatment alternative for patients." He added, "We will continue to expand indications based on robust clinical research and pursue research and development to enhance our competitiveness in the global market."

This content was produced with the assistance of AI translation services.