K-New Drug Fexuprazan Shows Rapid Symptom Relief and Proven Safety in Indonesian patients
(Jakarta, April 24th, 2025)
Fexuprazan, a new treatment for gastroesophageal reflux disease (GERD) developed in South Korea by Daewoong Pharmaceutical, showed promising results in a study conducted on Indonesian patients.
The study confirmed Fexuprazan’s rapid action and reliable safety, offering a novel treeatment option for GERD patients in Indonesia.
Fexuprazan is a next-generation treatment for gastrointestinal diseases belonging to the P-CAB (Potassium-Competitive Acid Blocker) class, and it is recognized as the 34th novel drug developed in Korea. It was specifically designed to overcome the limitations of conventional PPI (Proton Pump Inhibitor) therapies.
Fexuprazan acts quickly to suppress gastric acid secretion, helping patients experience symptom relief from the early stages of treatment. It can be taken regardless of meal timing, which improves medication adherence. Its long-lasting efficacy also allows for once-daily dosing, providing convenience and consistent symptom control. In addition, Fexuprazan carries a low risk of drug-drug interactions, making it a safer option for patients with comorbidities who are taking multiple medications.
Interest in P-CAB drugs is rising among doctors in Indonesia, as patients often need faster relief and fewer food restrictions. In this context, Fexuprazan could help improve the daily comfort and quality of life of GERD patients.
A doctor-led clinical study, known as an Investigator-Initiated Trial (IIT), was carried out in Indonesia with 134 GERD patients. The study conducted at three sites in Jakarta—University Indonesia Hospital, Islam Cempaka Putih Hospital, and Menteng Mitra Afia Hospital.
According to the Investigator-Initiated Trial (IIT) conducted in Indonesia, Fexuprazan achieved the target outcome for heartburn control within four weeks, aligning with the recommended treatment duration stated in the Indonesian GERD clinical practice guideline, thereby validating its clinical effectiveness in real-world Indonesian patients.
The study assessed heartburn, chest pain, gastric acid reflux, and nausea symptoms using a self-reported questionnaire (GERD-Q, 0–18 points). While both groups showed meaningful symptom improvement at four and eight weeks, the Fexuprazan group stood out during the early treatment phase by providing faster relief and enhanced patient comfort.
In terms of nausea, Fexuprazan also demonstrated faster symptom relief. While the Esomeprazole group showed improvement starting at week 8, patients in the Fexuprazan group reported significant improvement as early as seven days after administration.
Based on the day to reach complete response that assessed based on the diary of subjects, Fexuprazan 40 mg demonstrated a faster complete response for the disappearance of heartburn and acid reflux symptoms compared to Esomeprazole 40 mg. Patients in the Fexuprazan group achieved complete symptom relief in an average of 15 days, which is approximately five days earlier than the Esomeprazole group, who reached complete response in an average of 20 days.
Furthermore, in quality-of-life assessments among GERD patients, the Fexuprazan group demonstrated greater improvement within the first seven days of treatment compared to the control group. This early symptom relief is particularly meaningful, as it directly contributes to better sleep, enhanced physical comfort, and improved daily functioning—offering substantial real-world benefits to patients.
Fexuprazan’s safety was also confirmed in this study. There were no statistically significant differences between the Fexuprazan and Esomeprazole groups regarding the incidence of treatment-emergent adverse events (TEAEs) or adverse drug reactions (ADRs) during the trial period. Moreover, no serious adverse events (SAEs) or deaths were reported.
Prof. Dr. dr. Ari Fahrial Syam, Chairman of the Indonesian Society of Gastroenterology and the study’s lead investigator, said: “Fexuprazan provided faster relief from heartburn and reflux symptoms for Indonesian patients. It will be a valuable new treatment option for GERD in Indonesia.”
This study is expected to support the update of Indonesia’s GERD treatment guidelines and the future approval of Fexuprazan in the local market. Daewoong Pharmaceutical also plans to study Fexuprazan in treating functional dyspepsia or other gastric acid related condition in indonesia.
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