JP-1366 20mg Versus Esomeprazole 40mg in Patients With Erosive Esophagitis

Phase 3 Completed 300 enrolled Onconic Therapeutics Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the efficacy and safety of JP-1366 20 mg compared to esomeprazole 40 mg in patients with erosive esophagitis

Timeline

Start: 2022-01-17
Primary completion: 2023-01-05
Completion: 2023-01-05

Outcome

Met primary endpoint

paper DISCUSSION: An 8-week therapy of zastaprazan 20 mg is noninferior to esomeprazole 40 mg in subjects with predominantly low-grade EE. PMID 38976448 ↗

Publications

Oh JH, Kim HS, Cheung DY, Lee HL, Lee DH, Kim GH, Choi SC, Cho YK, Chung WC, Kim JW, Yu E, Kwon H, Kim J, Kim J, Jung HY. Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis. Am J Gastroenterol. 2025 Feb 1;120(2):353-361. doi: 10.14309/ajg.0000000000002929. Epub 2024 Jul 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Esomeprazole	Small molecule	40 mg	—
Subject	JP-1366	Unknown	20 mg	—