Clinical Trials

Multiple clinical trials, primarily sponsored by IlDong Pharmaceutical Co Ltd, evaluate the pharmacokinetic profile and safety of besifovir across various physiological conditions. These include a Phase 1 study of unknown recruitment status investigating subjects with renal impairment and a completed Phase 4 study assessing the impact of food intake in healthy individuals. Together, these investigations aim to delineate the drug's therapeutic window, dosing adjustments, and metabolic characteristics.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04249908 Unknown status
Renal Impairment
IlDong Pharmaceutical Co Ltd
 2020-02-13 Phase 1
NCT03885778 Completed
Food Effect|Health Subjects
IlDong Pharmaceutical Co Ltd
 2019-01-13 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Besifovir is an acyclic nucleotide phosphonate that intracellularly converts to its active diphosphate form, selectively inhibiting viral DNA polymerase and disrupting hepatitis B virus genomic replication. By suppressing viral DNA synthesis and reducing viral load, this inhibition provides the foundation for treating chronic hepatitis B virus infection, supporting clinical evaluations of its safety and pharmacokinetics in healthy subjects and individuals with renal impairment.

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.