Azvudine

Phase 3Small molecule

HHenan Genuine Biotech Co., Ltd.

Azvudine is one of 119 small molecule programs targeting Chronic Hepatitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

118

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic HepatitisRecruiting

PneumoniaActive, not recruiting

Renal InsufficiencyRecruiting

Chronic HepatitisPhase 3

Recruiting

PneumoniaPreclinical

Active, not recruiting

Renal InsufficiencyPhase 1

Recruiting

Competition

Competitive Landscape

152 competitors in Pneumonia

#DrugCompanyPhaseTrials

Azvudine

HHenan Genuine Biotech Co., Ltd.

Phase 3

1 2

Plaquenil

Jazz Pharmaceuticals

Preclinical

1 3

Innohep

Jazz Pharmaceuticals

Preclinical

1 4

Jakafi

Incyte

Preclinical

1 5

Primaquine

Sanofi

Preclinical

1 6

Acanya

Pfizer

Preclinical

1 7

Prevacid

Takeda

Preclinical

1 8

Avlosulfon

AAlmirall, S.A.

Preclinical

4 9

Zantac 150

CChattem

Preclinical

2 10

Retrovir

BBp Consulting, Inc

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Chronic Hepatitis

NCT07307586

Clinical

Trials by Indication[1]

COVID-199 trials

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

Unknown status·SSoutheast University, China·N/A·NCT05642910·540 enrolled

Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness

Recruiting·PPeking Union Medical College Hospital·Phase 2/3·NCT05689034·1,096 enrolled

Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect of Azvudine Treatment: a Retrospective Cohort Study

Unknown status·FFifth Affiliated Hospital, Sun Yat-Sen University··NCT06006611·4,201 enrolled

Show 6 more trials

The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19

Completed·TThe First Affiliated Hospital of Zhengzhou University··NCT06349655·32,864 enrolled

Study on Safety and Clinical Efficacy of AZVUDINE in Initial Stage COVID-19 Patients (SARS-CoV-2 Infected)

Completed·HHRH Pharmaceuticals Limited·Phase 3·NCT05033145·312 enrolled

Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2/3·NCT05633433·1,550 enrolled

Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (SARS-CoV-2 Infected)

Completed·HHRH Pharmaceuticals Limited·Phase 3·NCT04668235·180 enrolled

A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection

Unknown status·SShandong Provincial Hospital·Phase 4·NCT05697055·410 enrolled

Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT05682599·300 enrolled

Efficacy and Safety1 trial

Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients

Unknown status· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech··NCT05675748·400 enrolled

Pneumonia1 trial

An Observational, Ambispective Cohort Study of Azvudine in the Treatment of Patients With COVID-19 Pneumonia

Unknown status·QQianfoshan Hospital··NCT05621993·500 enrolled

Interaction1 trial

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

Completed·HHenan Genuine Biotech Co., Ltd.·Phase 1·NCT07002242·15 enrolled

Adult Subject1 trial

A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects

Completed·HHenan Genuine Biotech Co., Ltd.·Phase 1·NCT06991634·24 enrolled

3 more indications

Clinical Trial1 trial

[14C] Mass Balance Clinical Trial of Azvudine in Healthy Male Subjects

Completed·HHenan Genuine Biotech Co., Ltd.·Phase 1·NCT07002281·6 enrolled

Renal insufficiency1 trial

A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects

Recruiting·HHenan Genuine Biotech Co., Ltd.·Phase 1·NCT07001436·40 enrolled

Chronic Hepatitis1 trial

A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B

Recruiting·ZZhigang Ren·Phase 3·NCT07307586·120 enrolled

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Azvudine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Azvudine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Azvudine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Henan Genuine Biotech Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: HHenan Genuine Biotech Co., Ltd.

Azvudine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

COVID-199 trials

Efficacy and Safety1 trial

Pneumonia1 trial

Interaction1 trial

Adult Subject1 trial

Clinical Trial1 trial

Renal insufficiency1 trial

Chronic Hepatitis1 trial

References

Drug Info

Quick Facts

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