Daewoong Pharmaceutical announced on Friday that its self-developed gastroesophageal reflux disease treatment, Fexucluee 40 mg (active ingredient: fexuprazan), has received regulatory approval in Indonesia.
The approved indication is for the treatment of erosive gastroesophageal reflux disease. Daewoong aims to aggressively expand Fexuclue’s prescription base in response to the growing number of gastroesophageal reflux disease (GERD) patients and increasing treatment demand in the Indonesian market.
In 2025, local healthcare professionals in Indonesia confirmed Fexuclue’s rapid onset of action and treatment efficacy for Indonesian patients through investigator-initiated clinical trials.
Furthermore, Daewoong recently submitted a clinical trial application (IND) to South Korea’s Ministry of Food and Drug Safety for a multinational Phase 3 study. This trial, jointly conducted in South Korea and Indonesia, aims to expand Fexuclue’s indication to include gastric ulcer treatment.
Currently, proton pump inhibitors (PPIs), the first-line treatment for GERD in Indonesia, face criticism for their slow onset of action – taking several days to achieve maximum effect – and inconvenient dosing requirements, as they must be taken before meals.
Moreover, structural limitations have raised ongoing concerns about PPIs’ short half-life, making it challenging to control nighttime acid secretion.
In contrast, Fexuclue offers rapid symptom relief from the start of treatment through its fast and stable gastric acid suppression mechanism, with effects that last considerably longer.
Fexuclue has now entered 30 countries globally, including South Korea. It has secured regulatory approval in 16 nations, among them South Korea, Indonesia, China, Mexico, and India, and is currently marketed in six countries.
Park Seong-soo, Chief Executive Officer (CEO) of Daewoong Pharmaceutical, stated that gaining approval in Indonesia, a key player and benchmark in the Southeast Asian pharmaceutical market, marks a significant milestone in Fexuclue’s global expansion. Leveraging the extensive regulatory experience and differentiated clinical data, it will continue to drive Fexuclue’s international growth.