Fexuclue (fexuprazan) / Daewoong Pharma - LARVOL DELTA

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

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

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

Efficacy and Safety of Fexuprazan Versus Esomeprazole for Gastroesophageal Reflux Disease-Related Chronic Cough: A Randomized, Double-Blind, Active-Controlled Exploratory Trial. (PubMed, Lung) - "These findings support the potential of P-CABs as a promising alternative to PPIs for patients with chronic cough requiring acid-suppressive therapy."

Clinical • Journal • Chronic Cough • Cough • Gastroenterology • Gastroesophageal Reflux Disease • Pulmonary Disease • Respiratory Diseases

Daewoong launches Fexuclu for gastritis treatment, secures health insurance coverage [Google translate] (Chosun Biz) - "Daewoong Pharmaceutical announced on the 2nd that it has officially launched its domestically developed 34th new drug, 'Fexuclu' (active ingredient: Fexuprazan hydrochloride), which has also obtained health insurance coverage for gastritis. The company explained that this expanded coverage provides fast and effective treatment options to about 5 million patients with gastritis at a cost of 30%."

Launch • Reimbursement • Gastrointestinal Disorder

Among the three P-CAB drugs, ‘Fexuclue’ has the highest ‘price competitiveness’ [Google translation] (HIT News) - "Among the three domestically produced new P-CAB drugs for gastroesophageal reflux disease, the second to be released, Daewoong Pharmaceutical's 'Fexuclue (ingredient: Fexuprazan)', has the lowest upper limit...According to the relevant industry on the 20th, Daewoong Pharmaceutical will lower the upper limit from 939 won to 901 won through negotiations on the linkage between usage and drug price. The change will be effective from March 1st...In the case of K-Cap, the first P-CAB formulation, the upper limit is maintained at 1,300 won. This is because a refund contract has been signed."

Reimbursement • Gastroesophageal Reflux Disease

Daewoong Pharm marks record-breaking performance driven by new drugs and global expansion plan (Korea Biomedical Review) - "Fexuclu, Korea's 34th homegrown new drug, surpassed 1 trillion won in global and domestic cumulative sales within just three years of launch, earning blockbuster status...Envlo, Korea’s 36th new drug, achieved annual sales exceeding 10 billion won for the first time last year, solidifying its presence in the SGLT-2 inhibitor market with strong blood sugar-lowering effects...Ursosan, a drug that treats liver diseases such as primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related cholestasis, generated 96.2 billion won in revenue and is expected to reach the 1 trillion won milestone this year....In 2024, Nabota recorded 186.4 billion won in sales, marking 27 percent compared to the previous year. Export sales accounted for approximately 84 percent of the total revenue."

Sales • Gastroesophageal Reflux Disease • Migraine • Overactive Bladder • Primary Biliary Cholangitis • Type 2 Diabetes Mellitus

Preference for On-Demand Fexuprazan Therapy in Gastroesophageal Reflux Disease: A Prospective Cohort Study. (PubMed, J Pers Med) - "Approximately 68% of the patients preferred on-demand therapy as a maintenance treatment. Based on the patient's preference for maintenance therapy, symptom control did not differ between continuous and on-demand therapy."

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet (clinicaltrials.gov) - P=N/A | N=9846 | Completed | Sponsor: Daewoong Pharmaceutical Co. LTD. | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastroesophageal Reflux Disease

Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab (clinicaltrials.gov) - P=N/A | N=10067 | Completed | Sponsor: Daewoong Pharmaceutical Co. LTD. | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastroesophageal Reflux Disease

A Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab (clinicaltrials.gov) - P=N/A | N=2874 | Active, not recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD. | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Jul 2025

Enrollment closed • Trial completion date • Gastroenterology • Gastroesophageal Reflux Disease

Fexuprazan safeguards the esophagus from hydrochloric acid-induced damage by suppressing NLRP1/Caspase-1/GSDMD pyroptotic pathway. (PubMed, Front Immunol) - "Esomeprazole, a representative PPI, and three currently marketed P-CABs (vonoprazan, tegoprazan, and fexuprazan) were used for pretreatment. Our findings reveal that all p-CABs exhibit anti-inflammatory properties, while fexuprazan inhibits inflammation and pyroptosis of esophageal cells caused by the gastric acid. Therefore, it is presumed to have additional benefits in gastroesophageal reflux disease in addition to suppressing gastric acid secretion."

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Inflammation • ANXA5 • CXCL8 • IL1B • IL6 • NLRP1 • TNFA

Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: Daewoong Pharmaceutical Co. LTD.

New P3 trial • Infectious Disease

Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients with Erosive Esophagitis. (PubMed, J Neurogastroenterol Motil) - "The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing."

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

The role of P-CABs in GERD. (PubMed, Am J Gastroenterol) - "However, some P-CABs including vonoprazan, tegoprazan and fexuprazan have been available in other countries since at least 2014. Relevant results are reviewed and inferences drawn for their use in the US. Lastly, consideration is given to additional, potential uses of P-CABs in the broader spectrum of GERD and some suggestions made for future research initiatives."

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder