Clinical Trials

Several completed clinical trials, sponsored by organizations including Shanghai Vinnerna Biosciences Co. Ltd. and Vigonvita Life Sciences, have evaluated the pharmacokinetic, safety, and therapeutic profiles of VV116. Spanning Phase 1 pharmacokinetic assessments to a Phase 3 clinical efficacy study, these investigations evaluated healthy subjects, patients with mild to moderate COVID-19, elderly individuals with underlying diseases, and cohorts with hepatic or renal impairment. Together, these studies establish the safety, pharmacokinetics, and clinical utility of VV116 across diverse viral disease states and special populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06093230 Completed
Subjects With Liver Function Injury|Normal Liver Function Subject
Shanghai Vinnerna Biosciences Co. Ltd.|Sponsor GmbH
 2023-07-28 Phase 1
NCT06093308 Completed
Elderly Subjects With Underlying Diseases
Shanghai Vinnerna Biosciences Co. Ltd.|Sponsor GmbH
 2023-07-12 Phase 1
NCT05895812 Completed
Subjects With Renal Impairment|Healthy Subjects
Shanghai Vinnerna Biosciences Co. Ltd.|Sponsor GmbH
 2023-05-08 Phase 1
NCT05582629 Completed
Mild to Moderate COVID-19
Shanghai Vinnerna Biosciences Co. Ltd.|Sponsor GmbH
 2022-10-21 Phase 3
NCT05221138 Completed
Healthy Subjects
Vigonvita Life Sciences
 2021-12-30 Phase 1

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

Check the VV116 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VV116 acts as an oral nucleoside candidate that, in its active nucleoside triphosphate form, targets and inhibits viral RNA-dependent RNA polymerase with an IC50 of 0.67 ± 0.24 μM, thereby blocking viral RNA synthesis. This targeted biochemical inhibition suppresses SARS-CoV-2 replication within host cells, mitigating viral burden and providing clinical relevance in the treatment of mild to moderate COVID-19.

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.