azvudine (FNC) / Granlen - LARVOL DELTA

Azvudine exhibits potent differentiation-inducing effect by targeting the TERT/p21 axis in acute myeloid leukemia. (PubMed, Biomed Pharmacother) - "In addition, increased ROS levels in the mitochondria by Azvudine modulated the Bcl-2 family proteins and promoted apoptosis, acting as a further anti-AML mechanism. Considering that telomerase-targeted therapies are currently under active clinical investigation, these compelling preclinical data justify the repositioning of Azvudine as an AML differentiation-inducing therapy."

IO biomarker • Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Oncology • BCL2 • CDKN1A • TERT • TP53

Construction of Minigenome Replicon of Nipah Virus and Investigation of Biological Activity. (PubMed, Viruses) - "Importantly, the minigenome replicon demonstrated sensitivity to type I/II/III interferons and antivirals (remdesivir, azvudine, molnupiravir), establishing its utility for drug screening. This study provides a safe and efficient platform for investigating NiV replication mechanisms and accelerating therapeutic development, circumventing the constraints of BSL-4 facilities while preserving key virological features."

Journal • CNS Disorders • Infectious Disease • Respiratory Diseases

A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Henan Genuine Biotech Co., Ltd.

New P1 trial

Early and Delayed Administration of Azvudine on Mortality of Adult Patients With COVID-19: A Retrospective Study (ATS 2025) - "The use of azvudine will reduce the risk of death in adult COVID-19 patients compared to without antiviral therapy and the benefit seems more significant within 8 days of symptoms onset."

Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Effectiveness of azvudine versus nirmatrelvir/ritonavir for hospitalized patients with SARS-CoV-2 infection and pre-existing liver diseases. (PubMed, Virol J) - P | "The effectiveness of azvudine may potentially comparable to nirmatrelvir/ritonavir in SARS-CoV-2 infected patients with pre-existing liver diseases with respect to all-cause death and composite disease progression, without serious safety concerns. Due to the existence of potential biases, further studies still need to evaluate the efficacy of these two drugs."

Journal • Hepatology • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor

A retrospective cohort study of the efficacy and safety of oral azvudine versus nirmatrelvir/ritonavir in elderly hospitalized COVID-19 patients aged over 60 years. (PubMed, Acta Pharm Sin B) - "Safety analysis revealed that azvudine treatment had a lower incidence of adverse events and higher lymphocyte levels than Paxlovid treatment. In conclusion, azvudine treatment is not inferior to Paxlovid treatment in terms of all-cause death, composite disease progression and adverse events in elderly hospitalized COVID-19 patients."

Clinical • Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor

Effectiveness and safety of azvudine versus nirmatrelvir/ritonavir in hospitalized patients with COVID-19. (PubMed, BMC Infect Dis) - "In hospitalized patients with COVID-19, the effectiveness of azvudine and nirmatrelvir/ritonavir was found to be comparable in various aspects, including the improved discharge rate, the improvement time, time to fever resolution, usage rates of high-flow nasal cannula, non-invasive mechanical ventilation, and invasive mechanical ventilation, rate of disease progression, time to discharge, and hospital length of stay. The occurrence of myocardial injury was higher in nirmatrelvir/ritonavir group compared to azvudine group, while no significant differences were observed in other adverse reactions."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Evaluation of the efficacy and mechanisms of azvudine in elderly patients with malignant tumors complicated by COVID-19. (PubMed, Acta Pharm Sin B) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor

Advances in the effectiveness and safety of azvudine treatment: a comprehensive review. (PubMed, Front Pharmacol) - "The review also addresses the importance of drug interactions and safety considerations, particularly in high-risk populations. Research should focus on optimizing second-generation inhibitors with enhanced effectiveness against SARS-CoV-2 variants, improving oral bioavailability, and minimizing adverse effects, ensuring more robust treatment options for COVID-19."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Composite outcome of oral azvudine vs. nirmatrelvir-ritonavir in COVID-19 patients: a retrospective cohort study. (PubMed, Front Pharmacol) - "Clinical decisions should prioritize patient-specific needs, accessibility, and cost-effectiveness. Further large-scale prospective studies are needed to validate these observations and refine subgroup-specific treatment strategies."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease

Efficacy and safety of azvudine versus nirmatrelvir/ritonavir in cancer patients with COVID-19. (PubMed, Sci Rep) - "The safety analysis of adverse events revealed no statistically significant differences between the two groups. In conclusion, we carried out the first analysis to compare the efficacy and safety of azvudine and Paxlovid in cancer patients with COVID-19 and demonstrated that azvudine significantly reduced the risk of all-cause death and composite disease progression among cancer patients with COVID-19 compared with Paxlovid."

Clinical • Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Adsorption Potential of Ag Nanoparticles with Azvudine (FNC) Investigated by Density Functional Theory and Raman Spectroscopy. (PubMed, Langmuir) - "Subsequently, the Raman spectra of FNC and the FNC-Ag6 complex are compared and analyzed, and the adsorption conformation of FNC on the silver surface is determined based on the SERS surface selection rule. The results provide a theoretical basis for exploring the mechanism of chemical enhancement between FNC and Ag nanoparticles."

Journal • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A multicenter, real-world cohort study: effectiveness and safety of Azvudine in hospitalized COVID-19 patients with pre-existing diabetes. (PubMed, Front Endocrinol (Lausanne)) - "Additionally, the safety was favorable. This study may provide a new strategy for the antiviral management of COVID-19 patients with diabetes."

Journal • Real-world evidence • Retrospective data • Diabetes • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease

Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study. (PubMed, Acta Pharm Sin B) - "The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China."

Clinical • Journal • Real-world evidence • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Coronavirus Disease 2019 Case Series in China: Sequelae and Effectiveness of Vaccination and Antiviral Drugs. (PubMed, Infect Drug Resist) - "This study investigated post-coronavirus disease 2019 (COVID-19) sequelae among a sample of the Chinese population, and determined the statistical significance of correlations between age, sex, number of COVID-19 vaccinations, number of SARS-CoV-2 infections, development of pneumonia, use of specific drugs (namatevir/ritonavir, azvudine, molnupiravir), chronic underlying diseases, and post-COVID-19 sequelae. There was no statistically significant difference in COVID-19 infection rates between males and females, although males were more prone to COVID-19 pneumonia. Young women with COVID-19 often experienced no sequelae, and elderly males exhibited a high mortality rate."

Journal • Asthma • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Real-world effectiveness and safety of oral Azvudine versus Paxlovid for COVID-19 in patients with kidney disease: a multicenter, retrospective, cohort study. (PubMed, BMC Infect Dis) - "This study is the first to report that the safety and effectiveness of Azvudine are not inferior to those of Paxlovid in COVID-19 patients with KD. This study provides additional treatment options for COVID-19 patients with KD."

Journal • Real-world evidence • Retrospective data • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease

Real-world effectiveness of azvudine versus nirmatrelvir-ritonavir in hospitalized patients with COVID-19 and pre-existing diabetes. (PubMed, iScience) - "Five sensitivity analyses verified the robustness of the results. Overall, azvudine may be comparable to nirmatrelvir-ritonavir in terms of both all-cause death and composite disease progression among hospitalized patients with COVID-19 and pre-existing diabetes, with acceptable adverse events."

Journal • Real-world evidence • Diabetes • Endocrine Disorders • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Respiratory Diseases

The Antiviral Efficacy and Safety of Azvudine in Hospitalized SARS-CoV-2 Infected Patients with Liver Diseases Based on a Multicenter, Retrospective Cohort Study. (PubMed, Adv Sci (Weinh)) - P | "Within 15 days after azvudine administration, no significant difference in liver function indexes and kidney function indexes is observed between the two groups except for a few time points. These findings demonstrate that azvudine shows potential clinical efficacy in improving all-cause mortality in hospitalized SARS-CoV-2 infected patients with liver diseases, with acceptable adverse effects."

Journal • Retrospective data • Hepatology • Immunology • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Effectiveness and Safety of Oral Azvudine for Elderly Hospitalized Patients With COVID-19: A Multicenter, Retrospective, Real-World Study. (PubMed, Adv Sci (Weinh)) - "The safety of Azvudine in elderly patients is acceptable. These findings indicate that Azvudine therapy can reduce the rate of all-cause death in hospitalized elderly patients with COVID-19, and without obvious adverse events."

Journal • Real-world evidence • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nucleoside reverse transcriptase inhibition enhances platelet production and megakaryocyte maturation in patients with COVID-19. (PubMed, Br J Haematol) - "A total of 177 patients were included, among which 64 received azvudine, 12 received nirmatrelvir-ritonavir and 101 patients received none. Finally, RNA-sequencing demonstrated that azvudine-treated MEG-01 exhibited a marked increase in VWF, TUBB1 and GP1BA, and upregulated genes associated with the PI3K/AKT and JAK/STAT signalling pathways. In conclusion, our findings indicated that nucleoside reverse transcriptase inhibition potentially enhances platelet production and megakaryocyte maturation in patients with COVID-19, suggesting a new therapeutic option for thrombocytopenia."

Journal • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Thrombocytopenia • TUBB1

Comparative Analysis of Viral Load Quantification Using Reverse Transcription Polymerase Chain Reaction and Digital Droplet Polymerase Chain Reaction. (PubMed, Int J Mol Sci) - "By employing both RT-qPCR and DDPCR techniques, we established a comparison between the quantification methodologies of the two approaches. Our findings illustrate that the quantification through DDPCR affords a superior means of monitoring viral load within lower respiratory tract samples, thus enhancing the assessment of disease progression, particularly in scenarios characterized by low viral loads."

Clinical • Journal • Polymerase Chain Reaction • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Real-world effectiveness and safety of oral azvudine versus nirmatrelvir‒ritonavir (Paxlovid) in hospitalized patients with COVID-19: a multicenter, retrospective, cohort study. (PubMed, Signal Transduct Target Ther) - "These findings suggest that azvudine therapy is not inferior to Paxlovid in hospitalized COVID-19 patients and has fewer adverse effects. Notably, azvudine may offer greater clinical benefit for patients with HCC."

Journal • Real-world evidence • Retrospective data • Hepatocellular Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor • CD4 • CD8

Azvudine efficacy in reducing mortality in COVID-19 patients. (PubMed, Eur J Med Res) - "The study suggests that in hospitalized patients with COVID-19, azvudine treatment significantly reduces patient mortality rates in hospitalized COVID-19 infections, wherein the effects are more pronounced in severe and critical patients."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunophenotyping characteristics and clinical outcome of COVID-19 patients treated with azvudine during the Omicron surge. (PubMed, Front Immunol) - "A low CD4+ T cell count may serve as a significant predictive indicator for identifying COVID-19 patients receiving azvudine treatment who are at an elevated risk of experiencing adverse outcomes. These findings may offer valuable insights for physicians in optimizing the administration of azvudine."

Clinical data • Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • CD4

Efficacy of azvudine plus dexamethasone in severe hospitalized patients with Omicron infection: a prospective multicenter study. (PubMed, Front Cell Infect Microbiol) - "This study is the first to indicate that treatment with AZV+DXM might benefit severe Omicron-infected patients compared with DXM treatment alone. This finding demonstrates, at least partly, the necessity of antiviral treatment in severe patients."

Clinical • Journal • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Vascular Neurology • CRP