Clinical Trials

Sponsored by HK inno.N Corporation, a Phase 1 clinical trial has completed recruitment to evaluate the oral mucosa absorption profiles and safety parameters of Tegoprazan following a single dose in healthy volunteers. By characterizing these early-stage pharmacokinetic behaviors in a healthy subject cohort, the study provides foundational human data to inform future therapeutic development. Currently, no other disease-focused clinical trials are cataloged for this agent.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04654065 Completed
Healthy
HK inno.N Corporation
 2021-01-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Tegoprazan product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tegoprazan functions as a potent and selective inhibitor of gastric H+/K+-ATPase, competitively blocking the enzyme to halt active proton secretion across the parietal cell membrane. This targeted inhibition suppresses gastric acid production, establishing the physiological basis for evaluating its mucosal absorption profiles and baseline pharmacodynamics in clinical studies involving healthy subjects.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.