Clinical Trials

Several clinical trials sponsored by Vertex Pharmaceuticals Incorporated have evaluated Lomibuvir (VX-222) for the treatment of hepatitis C and chronic hepatitis C virus infection. These Phase 1 and Phase 2 studies assessed the safety, efficacy, pharmacokinetics, and drug-drug interactions of VX-222 as monotherapy and in combination with agents such as telaprevir and peginterferon alfa-2. Although the majority of these clinical trials are completed, a clinical trial evaluating combination therapy was terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01080222 TERMINATED
Chronic Hepatitis C Virus Infection
Vertex Pharmaceuticals Incorporated
 2010-08 PHASE2
NCT01516918 COMPLETED
Chronic Hepatitis C Virus
Vertex Pharmaceuticals Incorporated
 2012-02 PHASE2
NCT01581138 COMPLETED
Chronic Hepatitis C Virus
Vertex Pharmaceuticals Incorporated
 2012-07 PHASE2
NCT00958152 Completed
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2009-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2020-09-30)

Check the Lomibuvir (VX-222) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lomibuvir selectively binds to the non-nucleoside allosteric site of the hepatitis C virus NS5B RNA-dependent RNA polymerase, inhibiting viral genome transcription and blocking viral RNA replication in host cells. By suppressing intracellular viral synthesis, this targeted enzymatic inhibition reduces viral load, supporting its therapeutic application in chronic hepatitis C virus infection.

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.