Clinical Trials

Multiple clinical trials evaluate Clevudine across Phase 1, Phase 2, and Phase 4 studies, focusing on conditions such as chronic hepatitis B, drug interactions, and hepatitis D co-infections. Driven by industry sponsors including Bukwang Pharmaceutical and Antios Therapeutics Inc, these investigations assess drug safety, tolerability, pharmacokinetics, and antiviral efficacy. Currently, recruitment statuses for these trials range from completed to terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05298332 Terminated
Chronic Hepatitis b
Antios Therapeutics Inc
 2022-03-29 Phase 1
NCT05137548 Completed
Drug Interaction
Antios Therapeutics Inc
 2021-10-27 Phase 1
NCT04847440 Terminated
Hepatitis B Chronic|Hepatitis D
Antios Therapeutics Inc
 2021-03-30 Phase 2
NCT04248426 Completed
Hepatitis B Chronic
Antios Therapeutics Inc
 2020-02-05 Phase 1
NCT00558818 Completed
Chronic Hepatitis B
Bukwang Pharmaceutical
 2007-06 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clevudine functions as a pyrimidine nucleoside analog that undergoes intracellular phosphorylation to its active triphosphate metabolite, which selectively inhibits hepatitis B virus DNA polymerase and reverse transcriptase to block viral DNA synthesis. This inhibition of viral DNA elongation suppresses hepatitis B viral replication, directly addressing the clinical progression of chronic hepatitis B and associated viral liver conditions.

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.