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

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

JP-1366 20mg Versus Esomeprazole 40mg in Patients With Erosive Esophagitis (clinicaltrials.gov) - P3 | N=300 | Completed | Sponsor: Onconic Therapeutics Inc. | Recruiting ➔ Completed

Head-to-Head • Trial completion • Gastrointestinal Disorder

Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Onconic Therapeutics Inc. | Not yet recruiting ➔ Completed

Trial completion

Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients With Gastric Ulcer (clinicaltrials.gov) - P3 | N=329 | Completed | Sponsor: Onconic Therapeutics Inc. | Not yet recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jul 2024 | Trial primary completion date: Oct 2023 ➔ Jul 2024

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

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) - "An 8-week therapy of zastaprazan 20 mg is non-inferior to esomeprazole 40 mg in subjects with predominantly low-grade EE. The healing rate at week 4 appears to be higher for zastaprazan than esomeprazole."

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

In Vitro Metabolism and Transport Characteristics of Zastaprazan. (PubMed, Pharmaceutics) - "Only M1 showed substrate specificity for P-gp. The findings indicated that drug-metabolizing enzymes, particularly CYP3A4/3A5, may have a significant role in determining the pharmacokinetics of zastaprazan while drug transporters may only have a small impact on the absorption, distribution, and excretion of this compound."

Journal • Preclinical • Breast Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • CYP1A2 • CYP3A4 • CYP3A5 • UGT2B17

Zastaprazan: First Approval. (PubMed, Drugs) - "Zastaprazan is also undergoing phase III development for the treatment of gastric ulcer and for the prevention of non-steroidal anti-inflammatory drug (NSAID)-induced peptic ulcer. This article summarizes the milestones in the development of zastaprazan leading to this first approval for erosive GERD."

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

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

Head-to-Head • New P3 trial • Gastroenterology • Peptic Ulcer

RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ZASTAPRAZAN COMPARED WITH ESOMEPRAZOLE IN EROSIVE ESOPHAGITIS [ZASTAPRAN EROSIVE REFLUX OESOPHAGITIS-1 STUDY (ZERO-1)] (DDW 2024) - P2 | "The healing rate at week 4 appears to be higher for zastaprazan than esomeprazole at week 4. These findings suggest that zastaprazan would be a promising alternative to proton pump inhibitors for the treatment of erosive esophagitis."

Clinical • P3 data • Gastrointestinal Disorder • GAST

Onconic Therapeutics Receives MFDS Approval for JAQBO, a New Treatment for Gastroesophageal Reflux Disease (GERD) (PRNewswire) - "Onconic Therapeutics...today announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved JAQBO (zastaprazan citrate) for the treatment of erosive gastroesophageal reflux disease (GERD) in adults...The MFDS approval of JAQBO is based on comprehensive results including the Phase III clinical trial across 28 sites in Korea....Onconic Therapeutics aims to launch JAQBO this year after listing for National Healthcare Insurance Reimbursement in Korea. Domestic sales of JAQBO will be handled by Jeil Pharmaceutical, Onconic Therapeutics's parent company."

Launch non-US • Non-US regulatory • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ZASTAPRAZAN COMPARED WITH ESOMEPRAZOLE IN EROSIVE OESOPHAGITIS [ZASTAPRAZAN EROSIVE REFLUX OESOPHAGITIS-1 STUDY (ZERO-1)] (UEGW 2023) - P2 | "An 8-week therapy of zastaprazan 20 mg is non-inferior to esomeprazole 40 mg in subjects with erosive oesophagitis. The healing rate at week 4 appears to be higher for zastaprazan than esomeprazole at week 4, which further investigation is warranted. These findings suggest that zastaprazan would be a promising alternative to proton pump inhibitors for the treatment of erosive oesophagitis."

Clinical • P3 data • Gastrointestinal Disorder • GAST

JP-1366: A novel and potent potassium-competitive acid blocker that is effective in the treatment of acid-related diseases. (PubMed, Pharmacol Res Perspect) - "JP-1366 exhibited a more than 2-fold higher inhibitory effect on esophageal injury than TAK-438 in GERD lesions and had a more potent inhibitory effect in indomethacin- or aspirin-induced gastric ulcer rat models than TAK-438. Additionally, JP-1366 inhibited gastric ulcers. These results support the possibility that JP-1366 is a good candidate drug for treating acid-related diseases."

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

Clinical Trial to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Onconic Therapeutics Inc.

New P1 trial

Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Onconic Therapeutics Inc.

New P1 trial