Daewoong Pharmaceutical said it has secured health insurance reimbursement for its novel drug Fexuclue (ingredient: fexuprazan) for the treatment of gastritis and has launched a 10mg tablet formulation to meet growing demand.

The expanded reimbursement is expected to benefit nearly five million gastritis patients annually by providing faster and more effective treatment options at a more affordable cost.

Fexuclue, Korea’s 34th locally developed novel drug, is a next-generation treatment for acid-related gastrointestinal diseases belonging to the P-CAB (potassium-competitive acid blocker) class. It was developed to overcome the limitations of conventional proton pump inhibitors (PPIs), offering rapid onset of action and effective symptom relief from the early stages of treatment.

Unlike PPIs, Fexuclue can be taken regardless of meal timing, improving patient compliance. Its long-lasting acid suppression also allows for once-daily dosing. It also poses a lower risk of drug-drug interactions, making it a safer choice for patients with comorbidities.

“With this reimbursement, Fexuclue is positioned to shift the paradigm of gastritis treatment—from acute to chronic cases—by overcoming the limits of existing therapies,” the company said. Under the new scheme, patients will only need to pay 30 percent of the drug’s cost.

Fexuclue earned its gastritis indication following a successful phase 3 trial in 2022, which demonstrated both efficacy in improving gastric mucosal lesions and safety in treating acute and chronic gastritis.

“Just as second-generation PPIs replaced H2 blockers, third-generation P-CABs like Fexuclue are expected to replace PPIs, with Fexuclue leading the transition,” Professor Kim Gwang-ha of the Department of Gastroenterology at Pusan National University Hospital said.

Since its launch, Fexuclue has rapidly gained traction in Korea’s gastroesophageal reflux disease (GERD) market, surpassing 100 billion won ($68.2 million) in annual sales last year, driven by its superior efficacy and patient-friendly profile.

Daewoong now aims to position Fexuclue as a blockbuster treatment with over 150 billion won in annual sales, leveraging the gastritis indication to further boost its presence in the digestive health sector.

In addition to its approved indications—erosive GERD and acute/chronic gastritis—Fexuclue is currently being studied for a broad range of new indications, including NSAID-induced ulcer prevention, Helicobacter pylori eradication, and non-erosive reflux disease (NERD).

“The reimbursement approval marks meaningful progress in improving the quality of life for Korea’s 5 million gastritis patients,” Daewoong CEO Lee Chang-jae said. “We will continue to pursue patient-centric R&D and expand Fexuclue’s global competitiveness as a next-generation GI treatment.”