Azvudine

Overview

Azvudine is under investigation in clinical trial NCT04668235 (Study on Safety and Clinical Efficacy of AZVUDINE in COVID-19 Patients (Sars-cov-2 Infected)).

Indication

⑴用于与核苷逆转录酶抑制剂及非核苷逆转录酶抑制剂联用，治疗高病毒载量的成年HIV-1感染患者。 ⑵用于治疗普通型新型冠状病毒肺炎（COVID-19）成年患者。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects	2025/06/03	NCT07001436	Phase 1	Recruiting	Henan Genuine Biotech Co., Ltd.
A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects	2025/05/28	NCT06991634	Phase 1	Completed	Henan Genuine Biotech Co., Ltd.
The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19	2024/04/05	NCT06349655	N/A	Completed	The First Affiliated Hospital of Zhengzhou University
Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect of Azvudine Treatment: a Retrospective Cohort Study	2023/08/23	NCT06006611	N/A	Active, not recruiting	Fifth Affiliated Hospital, Sun Yat-Sen University
A Study of Efficacy and Safety of Azvudine vs. Nirmatrelvir-Ritonavir in the Treatment of COVID-19 Infection	2023/01/25	NCT05697055	Phase 4	Recruiting	Shandong Provincial Hospital
Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness	2023/01/18	NCT05689034	Phase 2	Recruiting	Peking Union Medical College Hospital
Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China	2023/01/12	NCT05682599	Phase 2	Recruiting	Shanghai Henlius Biotech
Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients	2023/01/09	NCT05675748	N/A	Not yet recruiting	Shanghai Henlius Biotech
The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial	2022/12/08	NCT05642910	Not Applicable	Recruiting	Southeast University, China
Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19	2022/12/01	NCT05633433	Phase 2	Recruiting	Shanghai Henlius Biotech

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Azvudine Tablets	河南真实生物科技有限公司	国药准字H20210036	化学药品	片剂	7/20/2021
Azvudine Tablets	河南真实生物科技有限公司	国药准字H20210035	化学药品	片剂	7/25/2022

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Azvudine Shows Comparable Effectiveness to Nirmatrelvir/Ritonavir for COVID-19 Patients with Chronic Liver Disease

2 months ago

A multicenter retrospective study found that azvudine demonstrated effectiveness comparable to nirmatrelvir/ritonavir in reducing all-cause death and disease progression in COVID-19 patients with pre-existing chronic liver diseases.

Azvudine Shows Similar Efficacy to Nirmatrelvir-Ritonavir in COVID-19 Treatment

9 months ago

A recent study compared azvudine to nirmatrelvir-ritonavir in treating COVID-19, finding no significant difference in 28-day mortality between the two antiviral therapies.

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