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

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

Onconic Therapeutics wins approval for dissolvable GERD tablet (Chosun Biz) - "An orally disintegrating tablet (ODT) formulation that can be taken without water has been newly added to Ja Q Bo (ingredient name: zastaprazan), the 37th domestically developed new drug for gastroesophageal reflux disease. It dissolves quickly in the mouth and is easy to swallow, which is expected to help older patients. Onconic Therapeutics said on the 31st that the orally disintegrating tablet formulation of the potassium-competitive acid blocker (P-CAB) class new drug Ja Q Bo received marketing approval from the Ministry of Food and Drug Safety."

Korea approval • Gastroesophageal Reflux 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

Phase 1 Study of JLP-2302 and JP-1366: PK and Safety in Healthy Volunteers (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Onconic Therapeutics Inc.

New P1 trial

Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux Disease (clinicaltrials.gov) - P3 | N=321 | Not yet recruiting | Sponsor: Onconic Therapeutics Inc.

New P3 trial • Gastroenterology • Gastroesophageal Reflux Disease

Clinical Trial to Evaluate the Efficacy of Probit-Based Triple Therapy for Helicobacter Pylori Eradication (clinicaltrials.gov) - P4 | N=103 | Not yet recruiting | Sponsor: Samsung Medical Center

New P4 trial • Infectious Disease

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

Evaluation of drug-drug interaction potentials between JP-1366 and celecoxib using physiologically based pharmacokinetic modeling. (PubMed, Transl Clin Pharmacol) - "At doses of 20 mg of zastaprazan citrate (JAQBO® tablet) and 200 mg of celecoxib, multiple oral doses of zastaprazan every 24 hours for 7 days did not increase celecoxib's area under the curve (AUC) and maximum plasma concentration (Cmax), with ratios of 1 in both AUC and Cmax, indicating no effect of zastaprazan on celecoxib's PK. The PBPK modeling approach provides scientific predictions of DDIs between zastaprazan and celecoxib, guiding future clinical development."

Journal • PK/PD data • Gastroenterology

Ja Q Bo receives approval for gastric ulcers, enhancing treatment options in Korea (Chosun Biz) - "Onconic Therapeutics announced on the 17th that its domestically developed drug for gastroesophageal reflux disease, 'Ja Q Bo' (ingredient name: Jastaprazan citrate), has received additional approval for gastric ulcers from the Ministry of Food and Drug Safety."

Korea approval • Gastrointestinal Disorder • Peptic Ulcer

Observationa Study is a Prospective and Multi-institutional Observational Study. (clinicaltrials.gov) - P=N/A | N=5536 | Completed | Sponsor: Jeil Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Oct 2026 ➔ Apr 2025 | Trial primary completion date: Jul 2026 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Gastroenterology • Gastroesophageal Reflux Disease

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, PARALLEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A ZASTAPRAZAN IN PATIENTS WITH GASTRIC ULCER (DDW 2025) - P3 | "Conclusion : An 8-week therapy of zastaprazan 20 mg demonstrated non-inferiority to lansoprazole 30 mg in the cumulative healing rate of gastric ulcers at 8 weeks, with similar safety profiles. No unexpected adverse events were identified, and the results support zastaprazan as an effective and safe treatment option for gastric ulcers."

Clinical • P3 data • CNS Disorders • Depression • Infectious Disease • Mood Disorders • Peptic Ulcer • Psychiatry

Observationa Study is a Prospective and Multi-institutional Observational Study. (clinicaltrials.gov) - P=N/A | N=6000 | Recruiting | Sponsor: Jeil Pharmaceutical Co., Ltd.

New trial • Gastroenterology • Gastroesophageal Reflux Disease

Onconic Therapeutics "Applies for Approval of Dissolvable Jaqbo" [Google translation] (HIT News) - "Onconic Therapeutics announced on the 3rd that it has applied for a new product approval for the P-CAB (potassium-competitive acid blocker) treatment Jaqbo (ingredient: zastaprazan) orally disintegrating tablets to the Ministry of Food and Drug Safety."

Korea filing • Gastroenterology • Gastroesophageal Reflux Disease

Gastroenterology/Hepatology: What You May Have Missed in 2024. (PubMed, Ann Intern Med) - "Treatment options for metabolic dysfunction-associated steatotic liver disease now include resmetirom, a recently approved drug for treatment of patients with moderate-to-severe fibrosis, and liver transplantation may now be an option in patients with unresectable colorectal liver metastases. Also featured are new data on the efficacy of indomethacin and pancreatic stent placement for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography and news on the efficacy and safety of zastaprazan, a new potassium-competitive acid blocker for reflux esophagitis. Finally, a recent randomized trial is highlighted that has dispelled concerns about potential harms of proton-pump inhibitors for stress ulcer prophylaxis in patients receiving invasive mechanical ventilation."

Journal • Colorectal Cancer • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Pancreatitis • Solid Tumor • Stress Ulcer • Transplantation

No. 37 New Drug ’Jaqbo’ Wins Korea New Drug Development Award [Google translation] (Jeil Pharma Press Release) - "The 37th new drug, 'Jaqbo', initiated by Jeil Pharmaceutical and completed by Onconic Therapeutics, won the honor of the Republic of Korea New Drug Development Award...Onconic Therapeutics...announced on the 26th that it will receive the grand prize in the new drug development category at the 26th Korea New Drug Development Awards hosted by the Korea Drug Development Association for its development achievements with 'Jaqbo'. The awards ceremony will be held at the Samjeong Hotel in Gangnam-gu, Seoul on the 28th."

Commercial • Gastroesophageal Reflux Disease

A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis (clinicaltrials.gov) - P3 | N=356 | Recruiting | Sponsor: Livzon Pharmaceutical Group Inc.

New P3 trial • Gastrointestinal Disorder

Onconic Therapeutics seeks new gastric ulcer indication approval for its P-CAB drug (Korea Biomedical Review) - "Onconic Therapeutics said it submitted an application to the Ministry of Food and Drug Safety (MFDS) to expand the indication of its gastroesophageal reflux disease (GERD) treatment, Jaqbo (ingredient: zastaprazan citrate), to include gastric ulcer treatment...The new indication application is based on the results of a phase 3 clinical trial conducted under the supervision of Professor Park Jong-jae of the Department of Gastroenterology at Korea University Guro Hospital. The trial involved 329 patients across 40 medical institutions in Korea and aimed to evaluate Jaqbo's efficacy and safety as a treatment for gastric ulcers....If the additional indication review proceeds smoothly, the company expects approval within the first half of this year."

Korea approval • Korea filing • Gastroesophageal Reflux Disease

Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers (clinicaltrials.gov) - P3 | N=364 | Recruiting | Sponsor: Onconic Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Peptic Ulcer

ZASTAPRAZAN: A Novel paradigm of GERD Treatment (KINGCA Week 2024) - "Sponsored by JEIL PHARMACEUTICAL."

Gastroesophageal Reflux Disease

Population pharmacokinetic analysis of zastaprazan (JP-1366), a novel potassium-competitive acid blocker, in patients and healthy volunteers. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "However, the model-based simulation indicated that the impact of disease status on zastaprazan exposure was not clinically meaningful. Overall, the current population PK model successfully characterized the observed zastaprazan PK in both patients with GERD and healthy volunteers."

Journal • PK/PD data • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • CYP2C19