Clinical Trials

Multiple completed Phase 1 clinical trials have evaluated lafutidine for gastrointestinal disorders, specifically focusing on gastric and peptic ulcers. Conducted by sponsors including Boryung Pharmaceutical Co. Ltd alongside academic institutions such as The Catholic University of Korea, these studies assessed parameters including drug-drug interactions, safety profiles, and pharmacokinetics. Together, these early-phase investigations establish essential safety and pharmacokinetic datasets to support the ongoing clinical development of lafutidine for acid-related ulcer disease.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02759224 Completed
Gastric Ulcer
Boryung Pharmaceutical Co. Ltd
 2016-04-15 Phase 1
NCT02581696 Completed
Peptic Ulcer
Boryung Pharmaceutical Co. Ltd|The Catholic University of Korea
 2015-08 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lafutidine functions as a histamine H2-receptor antagonist that selectively binds to H2 receptors on gastric parietal cells, thereby blocking histamine-stimulated activation of adenylate cyclase and downstream cyclic AMP signaling. This biochemical inhibition decreases gastric acid secretion and basal gastric acidity, creating a favorable physiological environment for mucosal recovery in clinical conditions such as gastric ulcer and peptic ulcer.

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.