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Drug

Azvudine

Late-stage clinical development
ClassReplicase polyprotein 1ab inhibitor
RxNorm1704278ChEMBLCHEMBL519846UNIIIJ2XP0ID0K
3
Active clinical trials
3
Protein targets
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.

Clinical trial2025-12-29Results expected Q4 2026 · ClinicalTrials.gov

A Non-randomized, Open, Parallel, Single-dose Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects

Clinical trial2025-08-30Primary completion · ClinicalTrials.gov

A Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adult Participants With COVID-19 Who Are at Increased Risk of Progressing to Severe Illness

Clinical trial2025-06-30Primary completion · ClinicalTrials.gov

A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2

Clinical trial2024-06-15Primary completion · ClinicalTrials.gov

An Open, Parallel Design Clinical Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects in Single and Multiple Doses

Clinical trial2023-06-20Completed · ClinicalTrials.gov

A Prospective Multicenter, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Azvudine vs. Nirmatrelvir-Ritonavir in Hospitalized Patients With Moderate to Severe COVID-19 Infection

Clinical trial2023-05-21Primary completion · ClinicalTrials.gov

A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2 in China

Clinical trial2023-04-15Primary completion · ClinicalTrials.gov

A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Aluvia

Clinical trial2023-02-21Completed · ClinicalTrials.gov

The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial

Clinical trial2023-01-31Primary completion · ClinicalTrials.gov

Evaluation of Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected): Phase III, Randomized, Double-blind, PLACEBO Controlled Trial

Clinical trial2022-08-10Completed · ClinicalTrials.gov

Evaluation of the Safety and Clinical Efficacy of AZVUDINE: Randomized, Double-blind, Placebo-controlled Study in Mild Stage Patients Infected With the SARS-CoV-2 Virus

Clinical trial2022-07-27Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Azvudine
RxNorm CUI
1704278
ChEMBL ID
CHEMBL519846
UNII
IJ2XP0ID0K
Primary mechanism
Replicase polyprotein 1ab inhibitor

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Replicase polyprotein 1ab
rep · P0DTD1
INHIBITORReplicase polyprotein 1ab inhibitor
Reverse transcriptase/RNaseH
pol · Q72547
INHIBITORHuman immunodeficiency virus type 1 reverse transcriptase inhibitor
Reverse transcriptase
reverse transcriptase · Q06347
INHIBITORReverse transcriptase inhibitor

Clinical trials

11 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
11
registered trials across all phases
LATEST COMPLETION 2023
3
Active studies
3
Recruiting
7
Late-stage (III+)
4
Completed
4
Discontinued
PHASE DISTRIBUTIONn = 11
Phase 13Phase 21Phase 2 / 32Phase 33Phase 41Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Prospective Multicenter, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Azvudine vs. Nirmatrelvir-Ritonavir in Hospitalized Patients With Moderate to Severe COVID-19 Infection

Unknown statusPH IVShandong Provincial Hospitaln=4102023

A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.

RecruitingPH IIIZhigang Renn=1202027

A Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adult Participants With COVID-19 Who Are at Increased Risk of Progressing to Severe Illness

RecruitingPH II/IIIKey trialPeking Union Medical College Hospitaln=1,0962025

A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2

Unknown statusPH II/IIIKey trialShanghai Henlius Biotechn=1,5502024

Evaluation of Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected): Phase III, Randomized, Double-blind, PLACEBO Controlled Trial

CompletedPH IIIHRH Pharmaceuticals Limitedn=1802022

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open, Parallel Design Clinical Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects in Single and Multiple Doses

CompletedPH IHenan Genuine Biotech Co., Ltd.n=242023

A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Aluvia

CompletedPH IHenan Genuine Biotech Co., Ltd.n=152023

Evaluation of Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected): Phase III, Randomized, Double-blind, PLACEBO Controlled Trial

CompletedPH IIIHRH Pharmaceuticals Limitedn=1802022

Evaluation of the Safety and Clinical Efficacy of AZVUDINE: Randomized, Double-blind, Placebo-controlled Study in Mild Stage Patients Infected With the SARS-CoV-2 Virus

CompletedPH IIIHRH Pharmaceuticals Limitedn=3122022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials