Numerous clinical trials spanning Phase 1 through Phase 4 evaluate Azvudine for indications such as COVID-19, chronic hepatitis B, HIV-infection/AIDS, and pharmacokinetic profiles in healthy individuals and patients with renal insufficiency. Spearheaded by diverse sponsors including Henan Genuine Biotech Co., Ltd., Peking Union Medical College Hospital, and Shanghai Henlius Biotech, these studies range in recruitment status from completed and actively recruiting to not yet recruiting and unknown. Notably, late-phase trials have assessed the drug's safety and therapeutic efficacy in COVID-19 and chronic hepatitis B cohorts.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07307586 | RECRUITING | Chronic Hepatitis B; Azvudine |
Zhigang Ren |
2025-09-01 | PHASE3 |
| NCT07001436 | RECRUITING | Renal Insufficiency |
Henan Genuine Biotech Co., Ltd. |
2025-05-20 | PHASE1 |
| NCT05689034 | UNKNOWN | COVID-19 Respiratory Infection |
Peking Union Medical College Hospital |
2023-04-19 | PHASE2; PHASE3 |
| NCT07002281 | COMPLETED | Healthy |
Henan Genuine Biotech Co., Ltd. |
2024-07-22 | PHASE1 |
| NCT05633433 | UNKNOWN | SARS-CoV-2 Infection |
Shanghai Henlius Biotech |
2022-12-29 | PHASE2; PHASE3 |
| NCT05697055 | UNKNOWN | COVID-19 |
Shandong Provincial Hospital |
2023-01-21 | PHASE4 |
| NCT06991634 | COMPLETED | Healthy |
Henan Genuine Biotech Co., Ltd. |
2023-04-08 | PHASE1 |
| NCT05682599 | UNKNOWN | COVID-19 |
Shanghai Henlius Biotech |
2023-01-06 | PHASE2 |
| NCT05642910 | UNKNOWN | SARS-CoV-2 Infection |
Southeast University, China |
2022-10-18 | |
| NCT05689034 | Not yet recruiting | COVID-19 Respiratory Infection |
Peking Union Medical College Hospital |
2023-01-20 | Phase 2|Phase 3 |
| NCT07002242 | COMPLETED | Healthy |
Henan Genuine Biotech Co., Ltd. |
2022-07-06 | PHASE1 |
| NCT04668235 | COMPLETED | COVID-19 |
HRH Pharmaceuticals Limited |
2021-04-23 | PHASE3 |
| NCT05033145 | COMPLETED | COVID-19 |
HRH Pharmaceuticals Limited |
2022-01-15 | PHASE3 |
| NCT07002268 | COMPLETED | Healthy |
Henan Genuine Biotech Co., Ltd. |
2022-03-14 | PHASE1 |
| NCT04303598 | UNKNOWN | HIV-infection/Aids |
Henan Genuine Biotech Co., Ltd. |
2020-04-01 | PHASE3 |
| NCT07001488 | COMPLETED | Healthy |
Henan Genuine Biotech Co., Ltd. |
2022-02-21 | PHASE1 |
| NCT07001501 | COMPLETED | Healthy |
Henan Genuine Biotech Co., Ltd. |
2022-02-21 | PHASE1 |
| NCT07002255 | COMPLETED | Healthy |
Henan Genuine Biotech Co., Ltd. |
2021-12-20 | PHASE1 |
| NCT07002229 | COMPLETED | Healthy |
Henan Genuine Biotech Co., Ltd. |
2021-12-09 | PHASE1 |
| NCT05033145 | Completed | COVID-19 |
HRH Pharmaceuticals Limited|GALZU INSTITUTE OF RESEARCH TEACHING SCIENCE AND APPLIED TECHNOLOGY Brazil|Clinical Research Unit / High Complexity Center (CRU/HCC) / Galzu Institute |
2022-01-15 | Phase 3 |
| NCT04668235 | Completed | COVID-19 |
HRH Pharmaceuticals Limited|GALZU INSTITUTE OF RESEARCH TEACHING SCIENCE AND APPLIED TECHNOLOGY Brazil|UNIVERSIDADE ESTADUAL DO NORTE FLUMINENSE (UENF) Brazil |
2021-04-23 | Phase 3 |
| NCT04425772 | UNKNOWN | COVID-19 |
Henan Genuine Biotech Co., Ltd. |
2020-06-12 | |
| NCT04109183 | COMPLETED | AIDS |
Henan Genuine Biotech Co., Ltd. |
2017-10-10 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-12-29)
Check the
Azvudine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.