A team of esteemed Indonesian Key Opinion Leaders (KOLs), led by renowned gastroenterologist Prof. Dr. dr. Ari Fahrial Syam, SpPD-KGEH, will initiate a groundbreaking trial for Fexuprazan aimed to evaluate symptom relief and safety in Indonesian patients with Gastroesophageal Reflux Disease (GERD). This investigator-initiated trial (IIT), supported by Daewoong Pharmaceutical, represents a significant stride toward innovative GERD treatment solutions in Indonesia.
Fexuprazan, the 34th novel drug in South Korea developed by Daewoong Pharmaceutical, is a Potassium-Competitive Acid Blocker (PCAB) that offers rapid relief from the first dose, eliminating the need for acid-mediated activation required by Proton Pump Inhibitors (PPIs). This feature addresses common limitations of PPIs, such as delayed onset of action and incomplete acid suppression. Recent Phase 3 clinical trials in South Korea, have shown that Fexuprazan is more effective than esomeprazole, with more patients experiencing symptom relief within the first few days of treatment. Moreover, Fexuprazan's extended half-life of 9 hours supports improved control of nocturnal symptoms, which is critical for patient comfort and recovery.
This IIT received its IND on July 23 and will take place at three prominent locations in Jakarta: Rumah Sakit Universitas Indonesia (RSUI), Rumah Sakit Islam Cempaka Putih (RSI Cempaka Putih), and Rumah Sakit Menteng Mitra Afia (RSMMA). These sites were selected to ensure a broad and diverse Indonesia patient representation, crucial for comprehensive data on Fexuprazan’s efficacy across various demographics.
Compared to existing therapies, Fexuprazan is believed to significantly improve symptom (ex. Heartburn etc.) control and enhance patient quality of life. This trial underscores the commitment of Indonesian KOLs to address unmet medical needs through innovative research, with Daewoong providing support in the form of resources and expertise.
Prof. Dr. dr. Ari Fahrial Syam, SpPD-KGEH, head of the clinical trial, stated, "The insights from this trial will not only redefine GERD treatment in Indonesia but also set a benchmark for patient care standards nationwide. This research, deeply rooted in local needs, aims to elevate healthcare practices and ensure that our community benefits directly from these global advancements in medicine."
Seongsoo Park, CEO of Daewoong Pharmaceutical, added, "Our collaboration with Indonesian researchers not only propels medical innovation but also addresses the specific health needs of the Indonesian population. We are committed to enhancing patient care through groundbreaking treatments like Fexuprazan."
This initiative highlights the leadership of Indonesian researchers in global medical research and underscores Daewoong Pharmaceutical’s role in fostering innovative approaches to healthcare. The collaboration aims to improve treatment outcomes and enhance the quality of healthcare for GERD patients both in Indonesia and globally.
As of July 2024, Fexuprazan has either entered or is about to enter the markets in 30 countries, including Korea, the Philippines, Mexico, Ecuador, and Chile. Market applications have been submitted in 11 countries, including China, Brazil, and Saudi Arabia. Including 14 countries such as India and the UAE, where license agreement has been executed, Fexuprazan is poised to enter a total of 30 countries.
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[Profile of Prof. Dr. dr. Ari F Syam, Sp.PD-KGEH]
- Direct past president of the Indonesian Society for Digestive Endoscopy (2016-2019, 2019-2023)
- President of Indonesian Gastroenterologist Society (2023- current) Founder of Indonesian Gastroenterology Foundation
- Dean of Universitas Indonesia, Faculty of Medicine (2017 - 2025)
- Recently ranked among the top 500 researchers in SINTA (Indonesian Science and Technology Index), (2020)
