Fexuclue (fexuprazan) / Daewoong Pharma - LARVOL DELTA

Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori (clinicaltrials.gov) - P3 | N=461 | Completed | Sponsor: Daewoong Pharmaceutical Co. LTD. | Recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Apr 2025 | Trial primary completion date: Jan 2026 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

Second Generation Potassium-Competitive Acid Blockers Match Proton Pump Inhibitors in Healing and Safety for Erosive Esophagitis: A Systematic Review and Meta-Analysis of Four Double-Blind, Randomized Controlled Trials (ACG 2025) - "Second-generation potassium-competitive acid blockers (P-CABs)—notably Tegoprazan and Fexuprazan—provide faster, meal-independent and more durable pH elevation than the first-in-class agent Vonoprazan. Four double-blind RCTs comprising 1,085 patients with erosive oesophagitis (PPI = 543; P-CAB = 542) met eligibility. The efficacy endpoint showed Endoscopic healing at 4 weeks was achieved in 83 % of PPI-treated vs 87 % of P-CAB–treated participants (421/505 vs 448/514; RR 0.96, 95 % CI 0.91–1.01; I² = 0 %), and at 8 weeks in 93 % vs 95 % (478/512 vs 490/518; RR 0.99, 95 % CI 0.96–1.02; I² = 0 %). The Safety endpoint showed treatment-emergent adverse events occurred in 31 % of PPI and 28 % of P-CAB recipients (171/543 vs 156/549; RR 1.11, 95 % CI 0.93–1.32; I² = 0 %)."

Retrospective data • Review • Gastrointestinal Disorder

Four-Week Healing Rates of Erosive Esophagitis: A Network Meta-Analysis of P-CABs versus PPIs (ACG 2025) - "Twelve trials involving 4,263 patients evaluated 4-week healing rates in erosive esophagitis. Treatments included vonoprazan (32.8%), tegoprazan (9.1%), fexuprazan (5.9%), keverprazan (2.5%), zastaprazan (3.1%), linaprazan (4.2%), and PPIs (42.5%). Most patients (73.2%) had LA grade A or B esophagitis, while 26.8% had grade C or D. Only zastaprazan 20 mg demonstrated a statistically significant improvement in the overall healing rate compared to PPIs (OR: 2.75, 95% CI: 1.06 to 7.13)."

Retrospective data • Gastrointestinal Disorder

Potassium-Competitive Acid Blockers Versus Proton Pump Inhibitors in Patients With Grade C and D Erosive Esophagitis: A Meta-Analysis (ACG 2025) - "Six RCTs involving 2,836 patients (1,433 receiving PCABs and 1,403 receiving PPIs) were included from 1,208 citations. The studies evaluated Vonoprazan, Zastaprazan, and Fexuprazan (PCABs), and Lansoprazole and Esomeprazole (PPIs). In the subgroup analysis of four studies comparing vonoprazan 20 mg with lansoprazole 30 mg, vonoprazan demonstrated significantly higher healing rates at both 4 and 8 weeks: RR 1.12 (95% CI: 1.03 – 1.21, p = 0.005) at 4 weeks, and RR 1.12 (95% CI: 1.01 – 1.24, p = 0.005) at 8 weeks."

Retrospective data • Gastrointestinal Disorder

Mapping a Global Decade of Potassium-Competitive Acid Blockers Use: Geographic and Temporal Disparities in Scientific Productions (ACG 2025) - "Introduction: Potassium-competitive acid blockers (P-CABs), including vonoprazan, tegoprazan, and fexuprazan, have emerged as potent alternatives to proton pump inhibitors for acid-related disorders, particularly GERD and H. pylori eradication. A total of 670 P-CAB–related documents were published across 206 sources, with an annual growth rate of 13.53%. Research output rose steeply after 2014, correlating with the introduction of vonoprazan. Japan led all countries with 242 publications, followed by China (158), South Korea (100), and the USA (54)."

Clinical • Gastroesophageal Reflux Disease

PRESCRIPTION OF FIRST-LINE EMPIRICAL TREATMENTS FOR HELICOBACTER PYLORI INFECTION OUTSIDE EUROPE: RESULTS OF 10,000 CASES FROM THE WORLD-WIDE REGISTRY ON H. PYLORI MANAGEMENT (WORLDHPREG) (UEGW 2025) - "Most treatments lasted 14 days (86%), with PPIs prescribed at either low-dose (20 mg omeprazole equivalent b.i.d.) in 42% of cases or high-dose (80 mg omeprazole equivalent b.i.d.) in 36% of cases. Vonoprazan, tegoprazan and fexuprazan were prescribed in 5%, 2% and 1.3% of cases.Table 1. Most frequent first-line empirical treatments worldwide.CountryLATAMBrazilAfricaASEANAustraliaCanadaEgyptIndiaJordanPakistanSaudi ArabiaTreatment(a)N..."

Clinical • Dyspepsia • Gastroenterology • Infectious Disease

EVALUATION OF POTASSIUM-COMPETITIVE ACID BLOCKERS VERSUS PROTON PUMP INHIBITORS IN EROSIVE ESOPHAGITIS: A NETWORK META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS [WITHDRAWN] (UEGW 2025) - "The P-CABs included in these studies were vonoprazan, keverprazan, zastaprazan, tegoprazan, and fexuprazan, while the PPIs used were lansoprazole 30 mg and esomeprazole 40 mg. Most P-CABs demonstrated similar efficacy to PPIs. However, vonoprazan, particularly at a dose of 20 mg, showed superior healing and endoscopic remission compared to PPIs in patients with erosive esophagitis. However, larger trials are needed to confirm this superiority."

Retrospective data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Solid Tumor

Fexuprazan for the Prevention of Nonsteroidal Anti-Inflammatory Drug-Induced Peptic Ulcer: A New Player in the Gastroprotection Landscape. (PubMed, Gut Liver) - No abstract available

Journal • Gastroenterology • Peptic Ulcer

A Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab (clinicaltrials.gov) - P=N/A | N=2852 | Completed | Sponsor: Daewoong Pharmaceutical Co. LTD. | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastroesophageal Reflux Disease

Comparison of Fexuprazan and Esomeprazole for the Control of Nocturnal Gastroesophageal Reflux Symptoms: A Randomized, Crossover Study. (PubMed, J Neurogastroenterol Motil) - "Fexuprazan was more effective than esomeprazole in controlling nocturnal reflux symptom, particularly in patients with severe symptoms. Fexuprazan may offer a therapeutic advantage for patients with severe and persistent nocturnal reflux despite PPI therapy."

Journal • CNS Disorders • Gastroenterology • Gastroesophageal Reflux Disease • Sleep Disorder

Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis (clinicaltrials.gov) - P=N/A | N=12000 | Recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder

Recurrent fexuprazan-induced liver injury following unintentional re-exposure. (PubMed, Br J Clin Pharmacol) - "This report highlights a rare but reproducible adverse drug reaction to fexuprazan and emphasizes the importance of thorough drug history and postmarketing surveillance. To our knowledge, this is the first report of recurrent fexuprazan-induced liver injury confirmed by unintentional re-exposure."

Journal • Fatigue • Gastroenterology • Gastroesophageal Reflux Disease • Hepatology • Inflammation • Liver Failure

Fexuprazan mitigates NSAID-induced small intestinal injury by restoring intestinal barrier integrity in mice. (PubMed, Biomed Pharmacother) - "Fexuprazan demonstrated protective effects against NSAID-induced small intestinal injury, while esomeprazole did not. Its ability to preserve intestinal barrier integrity, modulate inflammatory responses, and restore gut microbiota composition highlights its therapeutic potential in NSAID-induced enteropathy."

Journal • Preclinical • Inflammation • ATG12 • ATG5 • BECN1 • CLDN1 • IL1B • IL6 • TJP1 • TNFA

Clinical pharmacokinetics of potassium competitive acid blockers: a systematic review and meta-analysis. (PubMed, Front Pharmacol) - "The search terms included "Potassium competitive acid blockers" or "P-CABs" or "revaprazan" or "vonoprazan" or "tegoprazan" or "fexuprazan" or "keverprazan" or "zastaprazan" and "pharmacokinetics"...Meta-analysis and qualitative studies indicated that clarithromycin significantly increased vonoprazan and tegoprazan exposure [geometric mean ratio (GMR) (90% confidence interval (CI))] of AUC and Cmax: 1.565 (1.443, 1.687) and 1.538 (1.454, 1.621) for vonoprazan, 2.624 (2.513, 2.735) and 1.876 (1.771, 1.981) for tegoprazan, respectively...It is important to select the appropriate P-CABs by considering the degree of influence on CYP enzymes, the dosage form, and food interactions. Studies on the interaction between P-CABs and antibiotics used to treat H. pylori infections, such as metronidazole, tetracycline, levofloxacin, or rifabutin, as well as non-vitamin K antagonist oral..."

Journal • PK/PD data • Retrospective data • Review • Infectious Disease • CYP2C19

Comparing the Efficacy and Safety of Fexuprazan and Lansoprazole for the Prevention of Nonsteroidal Anti-inflammatory Drug-Induced Peptic Ulcer. (PubMed, Gut Liver) - P3 | "Patients with musculoskeletal disease requiring long-term treatment with celecoxib, naproxen, or meloxicam were randomized to receive either fexuprazan 20 mg/day (n=212) or lansoprazole 15 mg/day (n=211) for 24 weeks. There were low rates of adverse drug reactions in the fexuprazan and lansoprazole groups (8.57% vs 4.78%, respectively p=0.12). Given its non-inferiority to lansoprazole and similar safety profile, fexuprazan is a promising alternative for the prevention of NSAID-induced PUs (ClinicalTrials.gov identifier NCT04784910)."

Journal • Gastroenterology • Gastrointestinal Disorder • Musculoskeletal Diseases • Peptic Ulcer

Comparing Proton Pump Inhibitors and Emerging Acid-Suppressive Therapies in Gastroesophageal Reflux Disease: A Systematic Review. (PubMed, Cureus) - "These studies examined the effectiveness of newer agents such as potassium-competitive acid blockers (P-CABs), including vonoprazan, fexuprazan, and tegoprazan, as well as the use of mucosal protective agents and varied PPI administration strategies (on-demand vs. continuous). On-demand PPI use showed similar outcomes to continuous use, suggesting it may be a viable option for certain patient populations. Overall, the review supports the growing role of individualized and alternative pharmacologic approaches in the effective management of GERD."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease • GAST

Advances in Gastroesophageal Reflux Disease Management: Exploring the Role of Potassium-Competitive Acid Blockers and Novel Therapies. (PubMed, Pharmaceuticals (Basel)) - "Emerging treatment options include potassium-competitive acid blockers (PCABs) like vonoprazan, which offer more potent and sustained inhibition of gastric acid secretion compared to traditional PPIs. Additionally, prokinetic agents such as itopride have gained attention due to their potential to improve GERD symptoms by enhancing gastrointestinal motility and accelerating gastric emptying. This article reviews the mechanisms of action, clinical efficacy, and potential of these novel therapeutic approaches in improving patient outcomes in GERD management. With the growing prevalence of PPI resistance and side effects, a personalized, multifaceted approach to treatment is becoming increasingly necessary to optimize care for patients with GERD."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Pain

Restoration of intestinal barrier function by fexuprazan, a potassium-competitive acid blocker, in Caco-2 cells and its higher gastrointestinal distribution in rats. (PubMed, Biomed Pharmacother) - "Treatment with fexuprazan, esomeprazole, tegoprazan, and vonoprazan significantly increased TEER values in a 3 % DSS-induced ulcerative colitis Caco-2 cells in a concentration-dependent manner. Fexuprazan showed a particularly high distribution in the liver and gastrointestinal tract in rats following oral administration of 2 mg/kg fexuprazan, which appears to be a positive characteristic of fexuprazan's effect on ulcerative colitis and gastric acid-related diseases although in vivo therapeutic efficacy of fexuprazan for ulcerative colitis requires further validation in both animal and human. In conclusion, fexuprazan can potentially restore intestinal barrier function by increasing the expression of tight junction genes and by strengthening the cell membrane integrity in DSS-induced colitis model."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CLDN1 • MUC1 • OCLN • TJP1

ANTI-INFLAMMATORY AND ANTIOXIDANT EFFECTS OF FEXUPRAZAN IN HELICOBATER PYLORI CAGA-INDUCED GASTRIC INFLAMMATION (DDW 2025) - "Materials and AGS human gastric carcinoma cells were infected with a CagA-positive H. pylori strain and then treated with 30 μg/mL fexuprazan and esomeprazole (control). Fexuprazan demonstrated anti-inflammatory and anti-oxidant effects in CagA-positive H. pylori -infected gastric epithelial cells. These findings suggest that fexuprazan offers a potential application in managing H. pylori -induced gastritis and other inflammatory gastric conditions."

Gastric Cancer • Gastrointestinal Disorder • Infectious Disease • Inflammation • Oncology • Solid Tumor • CXCL8 • NQO1 • TNFA

FEXUPRAZAN, A NOVEL POTASSIUM-COMPETITIVE ACID BLOCKER VS. ESOMEPRAZOLE IN INDIAN PATIENTS WITH EROSIVE ESOPHAGITIS: A PHASE 3, MULTICENTRE, RANDOMIZED, ACTIVE-CONTROLLED STUDY (DDW 2025) - No abstract available

Clinical • P3 data • Gastrointestinal Disorder

COMPARATIVE EFFECTIVENESS OF FEXUPRAZAN AND ESOMEPRAZOLE IN THE MANAGEMENT OF NOCTURNAL ACID BREAKTHROUGH. (DDW 2025) - "Conclusion Fexuprazan demonstrated superior efficacy in reducing the severity of NAB compared to esomeprazole. Both fexuprazan and esomeprazole alleviated NAB symptoms, and the symptoms remained improved even during the on-demand period after 4 weeks of treatment."

HEOR • CNS Disorders • Gastroesophageal Reflux Disease • Sleep Disorder

NORMAL VALUES FOR AMBULATORY 24-HOUR PH-IMPEDANCE MONITORING "ON" POTASSIUM-COMPETITIVE ACID BLOCKERS (PCABS). (DDW 2025) - "AIM To assess the impact of a standard daily dose of tegoprazan (TEGO) and fexuprazan (FEXU) over one week on 24-hour reflux parameters measured through pH-imp, and to establish normal reference values for 'on-therapy' PCAB treatment. Both TEGO and FEXU significantly reduced acid reflux episodes and the percentage of time with esophageal pH 4. These findings highlight the potential of pH-imp as a diagnostic tool for refractory GERD under PCAB therapy."

Gastroesophageal Reflux Disease

EFFICACY AND SAFETY OF FEXUPRAZAN IN PREVENTION OF NSAIDS-INDUCED PEPTIC ULCER COMPARED WITH LANSOPRAZOLE: RANDOMIZED, DOUBLE-BLIND, PHASE III TRIAL (DDW 2025) - P3 | "Patients diagnosed with a musculoskeletal disease requiring prolonged treatment with celecoxib, naproxen, or meloxicam were randomized to receive fexuprazan 20 mg/day (n=212) or lansoprazole 15 mg/day (n=211) for 24 weeks. Given its non-inferiority to lansoprazole and similar safety profile, fexuprazan appears a promising alternative to the latter drug in the prevention of NSAID-induced PUs. [ClinicalTrials.gov: NCT04784910]"

Clinical • P3 data • Gastroenterology • Musculoskeletal Diseases • Peptic Ulcer

FEXUPRAZAN: A MECHANISTICALLY ADVANCED P-CAB WITH REDUCED ALZHEIMER'S RISK (DDW 2025) - "Proton pump inhibitors (PPIs), such as omeprazole and esomeprazole, are widely used to manage acid-related disorders but have been linked to an increased risk of Alzheimer's disease (AD). Clinically, Fexuprazan achieves faster and more sustained acid suppression, reducing the variability of metabolism seen with PPIs and addressing concerns related to prolonged use. These findings underscore Fexuprazan's capacity to redefine acid-related disorder management, balancing efficacy with an improved safety profile, and mitigating potential long-term neurological risks associated with PPI therapy."

Metastases • Alzheimer's Disease • CNS Disorders • CHAT

Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis (clinicaltrials.gov) - P=N/A | N=12000 | Not yet recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New trial • Gastrointestinal Disorder