Clinical Trials

Multiple clinical trials across Phase 1 and Phase 2 development have evaluated inarigivir soproxil, focusing on chronic hepatitis B and hepatitis C virus infections alongside pharmacokinetic drug-drug interaction potential. Sponsored by organizations including F-star Therapeutics, Gilead Sciences, and Syneos Health, several clinical trials were successfully completed. However, a subset of Phase 2 studies assessing safety and antiviral efficacy in subjects with chronic hepatitis B was terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04023721 TERMINATED
Hepatitis B; HBV; Hepatitis B, Chronic
F-star Therapeutics, Inc.
 2019-06-18 PHASE2
NCT04059198 TERMINATED
Hepatitis B; HBV; Hepatitis B, Chronic
F-star Therapeutics, Inc.
 2019-10-10 PHASE2
NCT03434353 TERMINATED
Chronic Hepatitis B
Gilead Sciences
 2018-02-28 PHASE2
NCT03932513 TERMINATED
HBV; Hepatitis B; Hepatitis B, Chronic
F-star Therapeutics, Inc.
 2019-04-11 PHASE2
NCT03493698 COMPLETED
Drug Interaction Potentiation
F-star Therapeutics, Inc.
 2018-05-07 PHASE1
NCT03434353 Terminated
Chronic Hepatitis B
Gilead Sciences|F-star Therapeutics Inc.
 2018-02-28 Phase 2
NCT02751996 Completed
Hepatitis B|Hepatitis Viral
F-star Therapeutics Inc.
 2016-05 Phase 2
NCT01803308 Completed
Hepatitis C Infection
Syneos Health|F-star Therapeutics Inc.
 2013-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2020-07-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Inarigivir soproxil acts as an agonist binding to the pattern recognition receptors RIG-I and NOD2, which triggers downstream innate immune signaling cascades and promotes cellular antiviral gene expression. This activation of innate immunity suppresses viral replication within host cells, providing clinical relevance for treating chronic viral infections such as hepatitis B and hepatitis C.

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.