Fexuclue (fexuprazan) / Daewoong Pharma - LARVOL DELTA

OPTIMIZING FEXUPRAZAN TREATMENT DURATION FOR ENDOSCOPIC SUBMUCOSAL DISSECTION–INDUCED ARTIFICIAL GASTRIC ULCERS: A MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED TRIAL (UEGW 2026) - "Fexuprazan led to faster and more complete healing of ESD-induced gastric ulcers than esomeprazole, with a comparable safety profile, suggesting that effective healing can be achieved within approximately 6 weeks in most cases."

Clinical • Gastric Cancer • Peptic Ulcer • Solid Tumor

PRESCRIPTION OF FIRST-LINE EMPIRICAL TREATMENTS FOR HELICOBACTER PYLORI INFECTION OUTSIDE EUROPE: RESULTS OF 15,000 CASES FROM THE WORLD-WIDE REGISTRY ON H. PYLORI MANAGEMENT (WORLDHPREG) (UEGW 2026) - "Other regimens included triple therapy with PPI-amoxicillin-levofloxacin (9.1%) and dual therapy with PPI-amoxicillin (8.1%). The WorldHpReg demonstrates marked regional heterogeneity in first-line H. pylori therapies, with predominance of standard triple therapy with PPI-amoxicillin-clarithromycin and limited use of quadruple regimens, highlighting the need for local treatment protocols to improve eradication rates."

Clinical • Dyspepsia • Gastroenterology • Infectious Disease

Randomized controlled trial comparing 7-day fexuprazan-based and 14-day rabeprazole-based triple therapies for Helicobacter pylori eradication. (PubMed, Medicine (Baltimore)) - "Seven-day fexuprazan-based triple therapy demonstrated eradication efficacy comparable with that of 14-day rabeprazole-based therapy in treatment-naïve Korean patients with H. pylori infection. The fexuprazan-based regimen showed a similar safety profile and comparable incidence of adverse events with that of the rabeprazole-based regimen."

Clinical • Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease

Potassium-Competitive Acid Blockers as a New Frontier in Acid-Related Disorders and the Role of South Korean Pharmacological Innovation. (PubMed, Pharmaceuticals (Basel)) - "We analyze the clinical and structural developments of indigenous Korean agents, specifically tegoprazan and fexuprazan, the latter of which features an optimized 9-h elimination half-life engineered to mitigate nocturnal acid breakthrough. A critical evaluation of recent clinical evidence is provided, including the most recent 2024 prospective Phase III data, which demonstrate that 14-day P-CAB-based triple therapy achieves significantly improved eradication rates in high-clarithromycin-resistance environments. Furthermore, we explore the emerging 2025 trend toward personalized, on-demand maintenance therapy and address critical long-term safety considerations, including the duration-dependent risk of metachronous gastric cancer identified in recent multicenter longitudinal studies. Ultimately, the South Korean clinical framework is providing the foundational evidence for a global transition toward P-CAB-centered treatment algorithms, redefining the standards of care in..."

Journal • Review • Gastric Cancer • Gastroenterology • Gastroesophageal Reflux Disease • Infectious Disease • Oncology • Solid Tumor • CYP2C19

Efficacy of Fexuprazan-based Concomitant Therapy for Helicobacter pylori Infection. (PubMed, Digestion) - "Ten-day fexuprazan-based concomitant therapy showed favorable efficacy and tolerability as first-line treatment for H. pylori eradication. As this is the first clinical study to evaluate fexuprazan for H. pylori eradication, further comparative studies are needed to confirm these findings."

Journal • Infectious Disease

A Phase III Clinical Trial and Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients With Healed Erosive Esophagitis (clinicaltrials.gov) - P3 | N=420 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P3 trial • Gastrointestinal Disorder

Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer (clinicaltrials.gov) - P3 | N=384 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P3 trial • Peptic Ulcer

Potassium-competitive Acid Blockers in Gastroesophageal Reflux Disease and Functional Dyspepsia: A Korean Expert Review With Original Meta-analyses. (PubMed, J Neurogastroenterol Motil) - "This narrative review incorporating original meta-analyses summarizes the latest evidence from randomized controlled trials and meta-analyses, emphasizing the efficacy, safety, and clinical applications of P-CABs such as vonoprazan, tegoprazan, fexuprazan, keverprazan, and zastaprazan. Limited clinical and real-world data indicate that second-generation P-CABs do not exhibit significant hepatotoxicity, however, long-term hypergastrinemia and mucosal changes warrant further surveillance. This review highlights the evolving role of P-CABs in gastroesophageal reflux disease and FD and emphasizes the need for further research to refine their clinical positioning, optimize therapeutic strategies, and evaluate long-term safety outcomes."

Clinical • Journal • Review • Dyspepsia • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

Discovery of highly selective and potent CYP1B1 inhibitors for overcoming paclitaxel resistance in A549/Taxol cells. (PubMed, Eur J Med Chem) - "Our research group previously identified W-1, a key intermediate of Fexuprazan, as an inhibitor of CYP1B1 (IC50 = 0.16 μM). In the A549/Taxol drug-resistant cell model, C27 significantly enhanced the inhibitory effect of paclitaxel on the proliferation of resistant cells and effectively inhibited tumor cell migration and invasion. Pharmacokinetic studies revealed that C27 displayed good plasma stability and liver microsomal stability, with observable systemic exposure following both oral and intravenous administration in mice."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CYP1B1

Pharmacological safety and real-world efficacy of the potassium-competitive acid blocker fexuprazan in cardiovascular patients receiving antithrombotic therapy: a prospective cohort study (FEXGARD). (PubMed, Front Pharmacol) - "Subgroup analyses revealed no significant differences between users of antiplatelet agents, warfarin, and non-vitamin K antagonist oral anticoagulants (NOACs). This study provides clinical data on the safety and tolerability of fexuprazan in a high-risk cardiovascular population under long-term antithrombotic therapy. Elderly patients exhibited a greater increase in gastrin levels, warranting closer monitoring and further investigation."

Journal • Real-world evidence • Cardiovascular • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • GAST

Daewoong Pharmaceutical…that it has received approval from the Ministry of Food and Drug Safety (MFDS) for a phase 3 investigational new drug (IND) application evaluating Fexuclue Tab 40 mg (fexuprazan hydrochloride) for the treatment of gastric ulcers (Korea Biomedical Review) - "The phase 3 study will enroll 384 patients with gastric ulcers in a multinational, multicenter, randomized, double-blind, active-controlled, parallel-group trial."

New P3 trial • Gastrointestinal Disorder

Real-World Data on the Efficacy and Safety of Fexuprazan in Patients with Gastroesophageal Reflux Disease: Interim Analysis of Post-Marketing Surveillance. (PubMed, Gut Liver) - "Fexuprazan demonstrated consistent efficacy with a favorable safety profile in the real-world management of GERD, including in older patients. These interim results support the use of fexuprazan as a safe and effective treatment option, including in older patients."

Journal • P4 data • Real-world evidence • Gastroenterology • Gastroesophageal Reflux Disease

Efficacy and Safety of Fexuprazan-Based Modified High-Dose Dual Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial. (PubMed, Helicobacter) - "Fexuprazan-based m-HDDT with bismuth was non-inferior to PPI-based STT for H. pylori eradication and demonstrated comparable safety and excellent compliance. This clarithromycin-sparing regimen can be considered an alternative treatment option in regions with high macrolide resistance."

Clinical • Journal • Infectious Disease

Comparative efficacy and safety of fexuprazan versus esomeprazole in gastroesophageal reflux disease: a systematic review and meta-analysis. (PubMed, Front Med (Lausanne)) - "No statistically significant difference in the incidence of TEAEs or ADRs was observed between treatments, suggesting a comparable safety profile. https://www.crd.york.ac.uk/PROSPERO/view/CRD420261286108."

Journal • Retrospective data • Review • Gastroenterology • Gastroesophageal Reflux Disease

Comparison of the anti-inflammatory effects of esomeprazole and fexuprazan in lipopolysaccharide-stimulated RAW 264.7 macrophages. (PubMed, BMC Pharmacol Toxicol) - "These results suggest that FEXU has a superior anti-inflammatory effect relative to that of ESO, indicating its potential as an anti-inflammatory agent."

Journal • Inflammation • MAPK8 • MRC1

Daewoong Pharmaceutical announced Monday that it received approval from the Ministry of Food and Drug Safety for a new indication of its gastroesophageal reflux disease (GERD) therapy, Fexuclue (fexuprazan hydrochloride) 40 mg, for use in combination with antibiotics to eradicate Helicobacter pylori. (Korea Biomedical Review) - "Approval was granted based on results from a domestic, multicenter phase 3 clinical trial conducted from February 2024 to April 2025."

Korea approval • Gastroesophageal Reflux Disease

Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice (clinicaltrials.gov) - P=N/A | N=7000 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New trial • Real-world evidence • Gastroenterology • Peptic Ulcer

Daewoong Pharmaceutical Obtains Indonesian Approval for 'Fexuclu 40mg' [Google translation] (HIT News)

Approval • Gastroesophageal Reflux Disease

Study to Evaluate the Efficacy and Safety of Fexuprazan in Prevention of NSAIDs Induced Peptic Ulcer (clinicaltrials.gov) - P4 | N=360 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P4 trial • Gastroenterology • Peptic Ulcer

Fexuprazan for upper gastrointestinal protection in patients with ischemic stroke and gastroesophageal reflux disease (GERD) receiving antithrombotic therapy: A preliminary prospective single-arm observational Study. (PubMed, PLoS One) - "This preliminary prospective single-arm study using a structured symptom-based assessment suggests that fexuprazan may be associated with symptom relief in patients with AIS and GERD receiving antithrombotic therapy. However, due to the small sample size and lack of a control group, these findings should be interpreted as hypothesis-generating and warrant further confirmation in larger, controlled trials."

Journal • Observational data • Cardiovascular • Gastroenterology • Gastroesophageal Reflux Disease • Ischemic stroke

FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) (clinicaltrials.gov) - P=N/A | N=1000 | Not yet recruiting | Sponsor: Ewha Womans University Mokdong Hospital

HEOR • New trial • Atrial Fibrillation • Cardiovascular • Gastroenterology • Hematological Disorders

Total Synthesis of Fexuprazan. (PubMed, Org Lett) - "Selective C5-decarboxylation and conversion of the C4-carboxylic acid moiety into an N-methylaminomethyl group delivered fexuprazan. Notably, most intermediates, as well as the final product, were isolated by simple recrystallization, and the target compound was obtained on a gram scale, underscoring the practicality of this route."

Journal

SAINT-FEXUDAPT: Randomized Active-Controlled Trial Evaluating Fexuprazan (Fexuclue Tab) for Prevention Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy After Coronary Intervention (clinicaltrials.gov) - P=N/A | N=400 | Recruiting | Sponsor: SUK MIN SEO

New trial • Cardiovascular • Gastroenterology

Potassium-competitive Acid Blockers Versus Proton Pump Inhibitors for Erosive Esophagitis: A Systematic Review and Network Meta-analysis. (PubMed, J Neurogastroenterol Motil) - "Nineteen studies evaluating 5 P-CABs (vonoprazan, tegoprazan, keverprazan, fexuprazan, and zastaprazan) and 2 PPIs (lansoprazole and esomeprazole) were included. P-CABs, especially vonoprazan, showed superior efficacy compared to PPIs in both the initial and maintenance treatment of EE. These findings support the use of P-CABs as a potent and reliable first-line option for EE management, particularly in high-risk populations, with acceptable safety outcomes."

Clinical • Journal • Retrospective data • Review • Gastrointestinal Disorder

Retraction: Fexuprazan safeguards the esophagus from hydrochloric acid-induced damage by suppressing NLRP1/Caspase-1/GSDMD pyroptotic pathway. (PubMed, Front Immunol) - "[This retracts the article DOI: 10.3389/fimmu.2024.1410904.]."

Journal • NLRP1