azvudine (FNC) / Granlen - LARVOL DELTA

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

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

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

Nirmatrelvir/Ritonavir Reduces Infection Duration in Hospitalized Hematological Malignancies Patients with Mild-to-Moderate COVID-19: A Retrospective Study (ASH 2024) - P=N/A | "Patients diagnosed with severe COVID-19, or treated with convalescent plasma, azvudine, or molnupiravir, or with unknown vaccination status, were excluded. Other treatment regimens did not achieve a statistically significant difference in time to viral clearance. Nirmatrelvir/ritonavir use within five days reduced the time to viral clearance (HR=1.51, 95% CI 1.01-2.23).ConclusionsNirmatrelvir/ritonavir use within five days in hospitalized HM patients with mild-to-moderate COVID-19 does not reduce mortality but shortens infection duration."

Retrospective data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Identification of RdRp-NiRAN/JAK1 Dual-Target Drugs for COVID-19 Treatment. (PubMed, J Phys Chem B) - "Based on the MDCC method combined with molecular dynamics simulations, Azvudine and Citicoline among these 31 drugs showed stronger predicted binding affinities with the NiRAN domain as well as JAK1 compared to the reference drug Remdesivir. Further experimental verification, including a thermal shift assay and homogeneous time-resolved fluorescence assay, demonstrated that Azvudine was an RdRp-NiRAN/JAK1 dual-target drug. This work provided a previously unexplored mechanism of Azvudine for COVID-19 treatment and proposed a design concept for RdRp-NiRAN/JAK1 dual-target nucleoside drugs."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • JAK1

Validation study for assessing COVID-19 pneumonia treatments. (PubMed, Sci Rep) - "This study investigates the effectiveness of Azvudine and nirmatrelvir-ritonavir (Paxlovid) in treating COVID-19 pneumonia through an analysis of real-world clinical data. The Cox model demonstrated robustness in predicting outcomes, and a nomogram was developed for individualized recovery probability assessment. These results provide important insights into optimizing COVID-19 treatment and the potential of predictive models in clinical decision-making."

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

Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness (clinicaltrials.gov) - P2/3 | N=1096 | Recruiting | Sponsor: Peking Union Medical College Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Jun 2025

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Systematic evaluation of therapeutic effectiveness of Azvudine in treating COVID-19 hospitalized patients: a retrospective cohort study. (PubMed, Front Cell Infect Microbiol) - "Our study demonstrates that Azvudine has a significant positive impact on the clinical recovery of hospitalized patients with COVID-19. These findings provide important support for the use of Azvudine as a therapeutic option for COVID-19, given the current divergent views on its therapeutic efficacy and its importance in public health and medical care."

Journal • Retrospective data • Critical care • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Real-world effectiveness and safety of Azvudine in hospitalized patients with SARS-CoV-2 infection: a multicenter, retrospective cohort study. (PubMed, J Infect) - P | "This study suggested that azvudine may reduce all-cause death and composite disease progression in hospitalized patients with SARS-CoV-2 infection without serious adverse events. However, the findings are susceptible to some potential biases, and further studies still need to identify the efficacy of azvudine."

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

2'-Fluorinated nucleoside chemistry for new drug discovery: achievements and prospects. (PubMed, Natl Sci Rev) - "Among these fluorinated nucleosides, azvudine, developed by us, has been officially approved by the National Medical Products Administration for the treatment of coronavirus disease 2019 (COVID-19) and human immunodeficiency virus, indicating the therapeutic promise of fluorinated nucleosides. In view of the therapeutic promise of fluorinated nucleosides for antiviral and anticancer therapy, in this Review we will provide a comprehensive overview of well-established 2'-fluorinated nucleosides approved for use in the market or those in clinical stages for antiviral and antitumor therapies, highlighting the drug discovery strategies, structure-activity relationship studies, mechanisms of action, and preclinical/clinical studies and also discuss the challenges and future directions for nucleoside-based new drug discovery."

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