Daewoong Pharmaceuticals said on Monday that its potassium-competitive acid blockers (P-CAB)-based drug, Fexuclue (ingredient name: Fexuprazan hydrochloride), received an adaptation certificate for improving gastric mucosal lesions of acute and chronic gastritis.

As a result, Fexuclue has secured two indications within a month of its official launch in Korea -- treatment of erosive gastroesophageal reflux disease (40 mg), acute gastritis, and improvement of chronic gastritis gastric mucosal lesions (10 mg). The gastritis indication is expected to be added in December this year.

Daewoong conducted phase 3 clinical trials from May 2020 to August 2021 to evaluate the effectiveness and safety of Fexuclue related to gastritis for patients with acute or chronic gastritis at 24 hospitals in Korea.

The treatment effect of gastritis proved superior to placebo at 40.6 percent vs. 57.8 percent for the 20mg tablet.

Researchers also confirmed it as a safe drug because no significant adverse reactions occurred.

It is difficult to secure the superiority of the test drug in gastritis clinical trials as there are many cases where the natural healing rate is high in the case of mild erosion or impossible to cure even when treated. Thus, few existing gastritis treatments demonstrated superiority over placebo groups in phase 3 clinical trials.

The company said that clinical process strategies such as strengthening researcher networking, producing endoscopy guides, and continuous case study analysis have made this additional indication possible.

According to market surveyor UBIST, the domestic gastritis treatment market is worth about 350 billion won ($261 million). Gastritis is a common disease where inflammatory cells infiltrate the gastric mucosa. Most gastritis treatments suppress factors causing mucosal damage or enhance factors that defend mucosa, including antacids, histamine-2 receptor antagonists (H2RA), and proton pump inhibitors (PPI).

"Fexuclue is the only P-CAB drug in Korea to secure indications for gastritis treatment, bringing the company closer to the goal of developing a 'best-in-class' gastroesophageal reflux treatment.” Daewoong Pharmaceutical co-CEO Lee Chang-jae said.

Lee added that Fexuclue would establish itself as a blockbuster treatment based on the strength of the drug's efficacy, expanded indications, and Daewoong’s differentiated four-stage marketing strategy.