Daewoong Pharmaceutical's New Drug 'Pexuclu' Receives Approval for Gastritis Indication

The Only Domestic P-CAB Formulation

[Asia Economy Reporter Lee Gwanju] Daewoong Pharmaceutical announced on the 22nd that Pexuclu 10mg (active ingredient: fexuprazan hydrochloride), a P-CAB class drug, has been approved by the Ministry of Food and Drug Safety as the first in Korea for the indication of 'improvement of gastric mucosal lesions in acute and chronic gastritis.'

Within one month of its official launch in Korea, Pexuclu secured two indications: ▲treatment of erosive gastroesophageal reflux disease (40mg) and ▲improvement of gastric mucosal lesions in acute and chronic gastritis (10mg). The prescription for the gastritis indication is expected to begin in December this year.

The Phase 3 clinical trial to evaluate the efficacy and safety of Pexuclu for the gastritis indication was conducted at 24 hospitals nationwide from May 2020 to August last year, targeting patients with acute or chronic gastritis. The subjects were 300 adult men and women aged between 19 and under 75 years, who received either 20mg tablets once daily or 10mg tablets twice daily for two weeks to assess efficacy and safety compared to placebo.

Clinical results confirmed the therapeutic effect on gastritis by demonstrating superiority over placebo in the efficacy evaluation indicator, ‘effective rate of gastric mucosal erosion on upper gastrointestinal endoscopy,’ for both 20mg once daily and 10mg twice daily regimens. Safety evaluation showed no statistically significant differences between groups in the incidence of adverse reactions and drug-related adverse reactions, and no serious adverse reactions or drug-related adverse reactions occurred.

Daewoong Pharmaceutical is additionally conducting a Phase 3 clinical trial to add indications for maintenance therapy after treatment of erosive gastroesophageal reflux disease and prevention of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs), and plans to start clinical trials for Helicobacter eradication therapy. The company is also preparing to expand the lineup by developing oral disintegrating tablets and intravenous (IV) formulations for improved dosing convenience.

Lee Changjae, CEO of Daewoong Pharmaceutical, stated, “Starting with securing the gastritis indication, we plan to focus on strengthening Pexuclu’s product competitiveness through continuous addition of follow-up indications and development of various formulations,” and “Pexuclu will establish itself as a blockbuster therapeutic based on its strong efficacy, expanded indications, and Daewoong Pharmaceutical’s differentiated four-step verification marketing strategy and operational sales system.”

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