Jaqbo (zastaprazan) / Jeil, Livzon Pharma, Onconic Therapeutics - LARVOL DELTA

Efficacy and Safety of Zastaprazan, a Novel Potassium-Competitive Acid Blocker in Indian Patients With Erosive Esophagitis: A Phase 3, Multicenter, Randomized, Active-Controlled Study (ACG 2026) - "The cumulative rate of healing at week 8, was 99.06%(105/106) in test arm and 98.13%(105/107) in reference arm with a difference of 0.93 (95% confidence interval â2.23; 4.08, P= 0.5929) demonstrating non-inferiority of Zastaprazan to Esomeprazole. The healing rate at week 4 was 70.75%(75/106) in test arm and 66.36%(71/107) in reference arm. The reduction in FSSG and GERD-HRQL scores from baseline was statistically significant in both the groups (p< 0.0001)."

Clinical • P3 data • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

Effectiveness and Patient Satisfaction With Zastaprazan in Real-world Practice: A Large-Scale Prospective Observational Study. (PubMed, J Neurogastroenterol Motil) - "Safety was excellent, with only 3 cases of mild adverse reactions (0.05%) and no serious events. Zastaprazan was associated with clinically meaningful symptom improvement in GERD patients, regardless of prior medication history, including proton pump inhibitors or other P-CABs, with high patient satisfaction, and a favorable safety profile."

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

Onconic wins India nod for Jaqbo reflux drug... (Chosun Biz) - "The recommendation follows JaQBo's completion of phase 3 clinical trials in India last month and the submission of a new drug application (NDA)....Based on the recommendation, the company expects to receive final marketing authorization within the year. Accordingly, commercialization in India is also expected to accelerate in earnest."

Approval • Non-US regulatory • Gastroesophageal Reflux Disease

Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke (clinicaltrials.gov) - P3 | N=984 | Not yet recruiting | Sponsor: Asan Medical Center

New P3 trial • Cardiovascular • Gastroenterology • Ischemic stroke

Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis (clinicaltrials.gov) - P3 | N=384 | Not yet recruiting | Sponsor: Onconic Therapeutics Inc.

Head-to-Head • New P3 trial • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

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

CYP3A-Mediated Metabolism of Zastaprazan in Humans and Associated Drug-Drug Interactions. (PubMed, Pharmaceutics) - "By integrating in vitro data, clinical pharmacokinetic data and clarithromycin coadministration DDI data, a physiologically based pharmacokinetic (PBPK) model was developed and validated. Simulations predicted significant DDIs with strong CYP3A inhibitor (ketoconazole), with AUC ratios of 3.80. Moderate inhibitors (fluconazole and fluvoxamine) caused mild increases (AUC ratios: 1.14-1.74). Conversely, strong and moderate CYP3A inducers, rifampicin and efavirenz, produced pronounced DDIs, with AUC ratios of 0.22 and 0.50, respectively...The PBPK simulations suggest that JP-1366 may be a moderately sensitive CYP3A substrate and a moderate inhibitor of sensitive CYP3A substrates, while its perpetrator DDI risk toward other major CYP pathways appears limited. These findings support caution or monitoring when JP-1366 is co-administered with strong CYP3A modulators or sensitive CYP3A substrates."

Journal • Gastroenterology • Gastroesophageal Reflux Disease • CYP1A2 • CYP2C9

PCAB-AMI: Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute Myocardial Infarction (clinicaltrials.gov) - P3 | N=5000 | Recruiting | Sponsor: Samsung Medical Center | Not yet recruiting ➔ Recruiting | Phase classification: P4 ➔ P3

Enrollment open • Phase classification • Cardiovascular • Gastroenterology • Myocardial Infarction

Potassium-competitive acid blockers and proton-pump inhibitors for the healing and maintenance of erosive esophagitis: a comprehensive and updated systematic review with network meta-analysis. (PubMed, Esophagus) - "A frequentist NMA estimated risk ratios (RRs) with 95% confidence intervals (95%CI), using vonoprazan 20 mg once daily (QD) and 10 mg QD as reference for healing and maintenance studies, respectively; ranking metrics (P-scores) were used descriptively. Zastaprazan 20 mg QD and esomeprazole 40 mg QD demonstrated the highest efficacy for EE healing and maintenance, respectively. Overall, PCABs did not consistently outperform dual-delayed release or double-dose PPIs."

Journal • Retrospective data • Review • Gastrointestinal Disorder

Zastaprazan, a Novel Potassium-Competitive Acid Blocker, for Acid-Related Disorders. (PubMed, J Clin Med) - "Notably, in erosive esophagitis, zastaprazan 20 mg demonstrated faster healing at week 4 compared to esomeprazole 40 mg, whereas in gastric ulcers, zastaprazan 20 mg achieved a 100% healing rate at 8 weeks compared to 97.1% with lansoprazole 30 mg. Zastaprazan is approved in the Republic of Korea for the treatment of erosive esophagitis and gastric ulcer and is undergoing phase III clinical trials for the prevention of non-steroidal anti-inflammatory drug-induced peptic ulcer and the treatment of non-erosive reflux disease. In this review, we summarize and discuss the pharmacology, efficacy, and safety of zastaprazan in acid-related disorders."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Peptic Ulcer • CYP2C19

Potassium-competitive acid blockers for erosive reflux disease and stress ulcer prophylaxis: a narrative review. (PubMed, Pol Arch Intern Med) - "Within the class, the most mature efficacy and safety data are derived from vonoprazan, whereas newer agents, including zastaprazan, remain supported by a more limited evidence base...For zastaprazan specifically, phase III data show that 20 mg is noninferior to esomeprazole 40 mg at week 8, with higher week-4 healing rates in a predominantly low-grade population...Current intensive care unit guidelines continue to support PPIs or histamine-2 receptor antagonists for patients at high risk of stress-related gastrointestinal bleeding, and pantoprazole remains the best-established benchmark. This review integrates mechanistic, pharmacokinetic, efficacy, safety, regulatory, and guideline data relevant to P-CABs, with particular attention to zastaprazan, while distinguishing compound-specific findings from broader class-level considerations."

Journal • Critical care • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Stress Ulcer • CYP2C19

EZ-STAR: Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Yonsei University | Not yet recruiting ➔ Recruiting

Enrollment open

Cheil Pharmaceutical announced on the 16th that the potassium competitive gastric acid secretion inhibitor (P-CAB) "Jaqbo" recorded 21.2 billion won in the first quarter of this year, up 217.6% from the same period last year. (Korea Biomedical Review) - "...the gastric ulcer indication was added in June 2025, and in December, the oral disintegrating tablet formulation was approved. The formula was released in the first quarter of this year."

Launch non-US • Sales • Gastroesophageal Reflux Disease

EZ-STAR: Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Yonsei University

New P4 trial

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

PCAB-AMI: Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute Myocardial Infarction (clinicaltrials.gov) - P4 | N=5000 | Not yet recruiting | Sponsor: Samsung Medical Center

New P4 trial • Cardiovascular • Gastroenterology • Myocardial Infarction

Comparative efficacy and safety of potassium-competitive acid blockers and proton pump inhibitors for erosive esophagitis: a network meta-analysis of randomized controlled trials. (PubMed, EClinicalMedicine) - "At 8 weeks, zastaprazan 20 mg, vonoprazan 20 mg, and esomeprazole 40 mg demonstrated moderate-certainty superiority over rabeprazole 20 mg and omeprazole 20 mg with RDs ranging from 0.05 to 0.11, while only vonoprazan 20 mg demonstrated moderate-certainty benefit versus lansoprazole 30 mg (RD: 0.04)...Vonoprazan 20 mg and rabeprazole-ER 50 mg demonstrated moderate-certainty benefit compared with pantoprazole 40 mg (RDs: 0.12 and 0.09, respectively).At 24 weeks, vonoprazan 10 mg and 20 mg showed moderate-to-high-certainty benefit versus lansoprazole 15 mg (RDs: -0.11 and -0.13, respectively), while in direct comparisons, esomeprazole 20 mg outperformed lansoprazole 15 mg and pantoprazole 20 mg, with approximately 40-50% relative reductions in recurrence...Comparative trials evaluating newer P-CABs against optimized PPI strategies, including twice-daily dosing, are needed to evaluate efficacy and long-term safety, particularly with respect to hypergastrinemia and infection..."

Journal • Retrospective data • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Infectious Disease

Correction to: Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared to Esomeprazole in Erosive Esophagitis. (PubMed, Am J Gastroenterol) - No abstract available

Clinical • Journal • P3 data • Gastrointestinal Disorder

Randomized, Double-Blind, Active-Controlled, Parallel, Phase 3 Clinical Trial for Evaluating the Efficacy and Safety of Zastaprazan in Patients with Gastric Ulcers. (PubMed, Gut Liver) - P3 | "An 8-week therapy involving zastaprazan 20 mg demonstrated noninferiority to lansoprazole 30 mg in the cumulative rate of healing of gastric ulcers at 8 weeks, and the two demonstrated similar safety profiles. (ClinicalTrials.gov identifier NCT05448001)."

Clinical • Journal • P3 data • Gastroenterology • Gastrointestinal Disorder • Peptic Ulcer • GAST

GERD: Heartburn, Gastroesophageal Reflux Disease (clinicaltrials.gov) - P4 | N=160 | Recruiting | Sponsor: Incheon St.Mary's Hospital

New P4 trial • Gastroenterology • Gastroesophageal Reflux Disease

to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Onconic Therapeutics Inc.

New P1 trial

Pharmacokinetics, mass balance, and metabolism of the novel potassium-competitive acid blocker JP-1366 in healthy Chinese adults following a single oral dose of [14C]JP-1366. (PubMed, Front Pharmacol) - "The principal metabolic pathways involved oxidations and the following glucuronidation. http://www.chinadrugtrials.org.cn/, identifier CTR20244931."

Clinical • Journal • PK/PD data • Gastroenterology • Gastroesophageal Reflux Disease

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

Comparative Efficacy of Potassium-Competitive Acid Blockers, Proton Pump Inhibitors, and H2-Receptor Antagonists for Healing and Maintenance of Erosive Esophagitis: A Network Meta-Analysis of 164 Randomized Trials (ACG 2025) - "Introduction: Proton pump inhibitors (PPIs) transformed erosive esophagitis (EE) management in the 1990s, largely replacing histamine-2 receptor antagonists (H2RAs) as first-line therapy. Overall, 164 RCTs evaluated healing (n=117), maintenance (n=44), and both (n=3). For EE healing at week 8, zastaprazan 20mg QD (RR 1.17; 95%CI 1.09-1.26; P-score=0.95), dual-delayed release esomeprazole 40mg QD (RR 1.13; 95%CI 1.04-1.23; P-score=0.88), and dexlansoprazole 90mg QD (RR 1.10; 95%CI 1.06-1.15; P-score=0.84) were most efficacious. H2RAs consistently ranked lowest."

Retrospective data • Gastrointestinal Disorder