Phase 1 IND Amendment for Nasogastric Tube Administration of JLP-2302
Filed Phase 1 IND amendment (2026-05-11, MFDS) for nasogastric tube administration of JLP-2302 (Zastaprazan) 20mg ODT
Open-label, randomized, single-dose, crossover, fasting study in 48 healthy adults comparing oral vs. nasogastric tube PK and safety
Primary endpoints: Cmax and AUCt of Zastaprazan; trial duration ~12 months after IRB approval
Success could enable label expansion for nasogastric tube use (product already approved in Oct 2025)
Investment caution: statistical probability of final approval for investigational drugs is ~10%; results may fall short of expectations
KOSDAQ Filing Information
Filing: Major Management Matters Related To Investment Decision (Application For Approval Of Change In Clinical Trial Plan) (Application For Approval (Change Approval) Of Phase 1 Clinical Trial Plan For Comparative Evaluation Of Pharmacokinetics And Safety Of Jacubo Orally Disintegrating Tablet (JLP2302) (Zastaprazan Citrate) When Administered Via Nasogastric Tube)