Daewoong Pharmaceutical Indonesia

Daewoong Advances GERD Treatment Innovation in Indonesia through Fexuprazan IIT Study

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August 14, 2025

- Daewoong completed a local Fexuprazan trial in Indonesia, led by Prof. Ari, showing faster symptom relief and better adherence than Esomeprazole.

- Fexuprazan has expanded into over 30 countries including Indonesia, aiming to reach 100 global markets by 2027.

- The study supports Daewoong’s goal to position Indonesia as a clinical trial hub and expand access to advanced GERD therapies.

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(Jakarta, August 15th 2025)

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Daewoong held a Media Education Day to announce that a locally led Investigator-Initiated Trial (IIT) for the treatment of Gastroesophageal Reflux Disease (GERD) had been successfully conducted in Indonesia, spearheaded by Prof. Dr. Ari Fahrial Syam, SpPD-KGEH. This clinical trial marks a significant milestone in generating Indonesia-specific clinical data while opening a major opportunity for the adoption of Fexuprazan, a next-generation treatment from the Potassium-Competitive Acid Blocker (P-CAB) class.

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According to a global study published by Scarpignato et al. in the Annals of the New York Academy of Sciences (2020), approximately 1 in 4 people worldwide suffer from GERD, with prevalence steadily increasing across all regions.

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Meanwhile, the 2022 GERD Management Consensus issued by the Indonesian Society of Gastroenterology estimates that GERD affects 9.35% of the general population in Indonesia, based on validated data from the GERD-Q clinical questionnaire. This underscores the significant public health burden posed by the disease at a national level.

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Despite the widespread use of proton pump inhibitors (PPIs), many patients fail to achieve optimal therapeutic outcomes. The Fexuprazan IIT was initiated to address this unmet clinical need.

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“Our study demonstrates that Fexuprazan is not only therapeutically comparable to PPI therapy but also delivers faster symptom relief, better nausea control, and enhanced quality of life as early as the first week. Clinical data further confirm its favorable safety profile, with no serious adverse events reported and high patient compliance due to its convenient, once-daily, time-independent dosing,” said Prof. Ari during Daewoong Pharmaceutical’s Media Education Day.

Prof. Dr. dr. Ari Fahrial Syam, Sp.PD-KGEH (Chairman of PB PGI and Lead Researcher of the Fexuprazan IIT), presented the effects of Fexuprazan on stomach acid levels during Daewoong's Media Education Day, held on Thursday, August 14, 2025, in Jakarta.

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The study involved 134 adult patients across three major hospitals in Jakarta—RSUI, RSI Cempaka Putih, and RS Menteng Mitra Afia—comparing Fexuprazan 40mg with Esomeprazole 40mg. Results showed that patients receiving Fexuprazan reached symptom-free status from heartburn and regurgitation in an average of 15 days, significantly faster than the 20 days observed with Esomeprazole. Moreover, patient adherence was exceptionally high, supported by the convenience of once-daily dosing without meal-time restrictions.

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As a P-CAB molecule, Fexuprazan offers a more rapid and convenient solution for GERD patients, particularly those with suboptimal response to PPI-based therapies.

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“This study also represents a strategic value-add in strengthening Indonesia’s local clinical research capabilities,” added dr. Stella Melisa, Chief Medical Officer of Daewoong Pharmaceutical Indonesia. “Collaborating with local investigators allows us to generate real-world evidence tailored to the Indonesian population and support data-driven therapeutic decisions going forward,” she concluded.

Dr. Stella Melisa (Chief Medical Officer of Daewoong Pharmaceutical Indonesia) explained that Fexuprazan offers five key therapeutic benefits through the P-CAB (Potassium-Competitive Acid Blocker) mechanism, addressing unmet needs in PPI-based therapies, during Daewoong's Media Education Day on Thursday, August 14, 2025, in Jakarta.

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◆Fexuprazan on the Global Stage

Developed in South Korea, Fexuprazan has received clinical approval in multiple markets including South Korea, India, Mexico, Chile, Ecuador, Panama, and the Philippines. It has entered 30 countries through product launches in 6 countries, marketing approvals in 2 additional countries, NDA submissions in 16 countries, and export partnerships in 6 countries, with primary indications in gastrointestinal disorders.

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As part of its global expansion roadmap, Daewoong aims to extend access to Fexuprazan across 100 countries by 2027, addressing the need for faster-acting and more practical acid suppression therapies worldwide.

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Multiple global Phase III clinical trials have confirmed that Fexuprazan is non-inferior to PPIs (e.g., esomeprazole) in healing erosive esophagitis, with added advantages in rapid onset and nocturnal acid control. Recommendations for the use of P-CAB have been issued in various countries, including South Korea, Thailand, Japan, the United States, the European Union, China, Indonesia, Mexico, and Brazil.

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◆Expanding Access to Innovative Therapy in Indonesia

This local IIT reinforces Daewoong’s long-term commitment to supporting independent research collaboration and establishing Indonesia as a clinical trial hub in Southeast Asia. The local validation of Fexuprazan’s effectiveness is expected to accelerate its registration process and facilitate faster patient access to modern GERD therapy.

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The study also contributes to building a stronger foundation of locally relevant scientific evidence, addressing a key gap in the adoption of novel therapies in Indonesia’s national healthcare system.

Mr. Baik In Hyun (Head of Business, Daewoong Pharmaceutical Indonesia) shared the company’s vision to become the number one pharmaceutical company in Indonesia by 2030, during Daewoong's Media Education Day on August 14, 2025.

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- The study supports Daewoong’s goal to position Indonesia as a clinical trial hub and expand access to advanced GERD therapies.

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