Fexuclue (fexuprazan) / Daewoong Pharma - LARVOL DELTA

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

ANTI-INFLAMMATORY AND ANTIOXIDANT EFFECTS OF FEXUPRAZAN IN HELICOBATER PYLORI CAGA-INDUCED GASTRIC INFLAMMATION (DDW 2025) - No abstract available

Inflammation

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) - No abstract available

HEOR • 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) - No abstract available

Clinical • P3 data • Gastroenterology • Peptic Ulcer

FEXUPRAZAN: A MECHANISTICALLY ADVANCED P-CAB WITH REDUCED ALZHEIMER'S RISK (DDW 2025) - No abstract available

Metastases • Alzheimer's Disease • CNS Disorders

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

EFFICACY AND SAFETY OF FEXUPRAZAN IN PATIENTS WITH EROSIVE ESOPHAGITIS AND MODERATE SEVERITY OF MAJOR SYMPTOMS: POOLED ANALYSIS OF TWO RANDOMIZED CONTROL TRIALS IN SOUTH KOREA AND CHINA (UEGW 2024) - P3 | "The efficacy of fexuprazan in treating EE was not inferior to that of esomeprazole in Asian populations. In subjects with at least a moderate severity of major symptoms, symptom relief in the fexuprazan group was higher in the first 3 days, regardless of full-day or nighttime. In terms of safety, serum gastrin level was tolerable in both groups, and no serious adverse events occurred in the fexuprazan group."

Retrospective data • Gastrointestinal Disorder • GAST

Network meta-analysis of comparing different dosages of potassium-competitive acid blocker with proton pump inhibitor in acid related disorders. (PubMed, Clin Transl Gastroenterol) - "K30 may be the most effective dosage for increasing the healing rate of gastric/duodenal ulcers. For erosive esophagitis, V40 and T50 may be the preferred dosages."

Journal • Retrospective data • Gastrointestinal Disorder • Peptic Ulcer

Scalable Synthesis of the Key Fexuprazan Intermediate and Investigation of a Reaction Mechanism. (PubMed, ACS Omega) - "In addition, the mechanism of the cyclization reaction was proposed. This method has potential for industrial production because the raw materials are inexpensive, the procedure is simple, and a high yield is obtained."

Journal

Safety of potassium-competitive acid blockers in the treatment of gastroesophageal reflux disease. (PubMed, Expert Opin Drug Metab Toxicol) - "Currently, four different drugs (vonoprazan, tegoprazan, fexuprazan, keverprazan) are marketed in some Asian countries, whereas only vonoprazan and tegoprazan are available in Western countries (U.S.A. Preclinical and clinical findings have highlighted p-CAB safety to be superimposable, to that of PPIs, in short-term treatments, although further studies are warranted to monitor their effects in long-term therapy. From an epidemiological point of view, the paucity of rigorous data for many variables (e.g. age, ethnicity, drug interactions, comorbidities, genetic polymorphisms, interindividual susceptibility, microbial dysbiosis) deserves a worldwide framework of continuous pre/post-marketing pharmacovigilance programs to reduce potential confounding factors and accurately link acute and chronic p-CAB therapy to adverse outcomes."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease

Potassium-competitive Acid Blockers: Current Clinical Use and Future Developments. (PubMed, Curr Gastroenterol Rep) - "Four different P-CABs (vonoprazan, tegoprazan, fexuprazan and keverprazan) are currently available...The available data show that-in the above two clinical indications-P-CABs provide similar or better efficacy in comparison with PPIs. Their safety in the short-term overlaps that of PPIs, but data from long-term treatment are needed."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease • Infectious Disease • Peptic Ulcer

Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial. (PubMed, Eur Arch Otorhinolaryngol) - "Fexuprazan improved symptoms and signs without no serious adverse events in patients with LPRD. In patients with severe symptoms, fexuprazan resulted in a faster symptom improvement than PPI."

Clinical • Journal • Cough • Osteoporosis • Otorhinolaryngology • Respiratory Diseases • Rheumatology

FEXUPRAZAN REDUCED HYDROCHLORIC ACID-INDUCED INFLAMMATION AND DAMAGE IN ESOPHAGEAL CELL LINES (UEGW 2024) - "Full abstracts will be published on 21 September 2024"

Preclinical • Inflammation

Efficacy of fexuprazan compared with rebamipide in Korean patients with gastritis: A matching-adjusted indirect comparison. (PubMed, World J Clin Cases) - "The two-week fexuprazan treatment was superior to the two-week rebamipide treatment and similar to the four-week rebamipide treatment for patients with gastritis."

Journal • Gastrointestinal Disorder

Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer (clinicaltrials.gov) - P3 | N=423 | Completed | Sponsor: Daewoong Pharmaceutical Co. LTD. | Not yet recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Dec 2023 | Trial primary completion date: Jul 2021 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Gastroenterology • Peptic Ulcer