azvudine (FNC)
/ Granlen
- LARVOL DELTA
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July 10, 2025
The effect of monotherapy versus combination antiviral therapy on all-cause mortality risk in COVID-19 patients.
(PubMed, Diagn Microbiol Infect Dis)
- "Therefore, Paxlovid alone reduced mortality risk in moderate and severe cases, while the combination therapy with two antiviral drugs also provided some protection. However, the type-specific impact of Azvudine treatment was notable, with mild cases experiencing significantly better survival rates."
Journal • Monotherapy • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
July 03, 2025
Effectiveness and safety of azvudine in the treatment of COVID-19 patients: a retrospective cohort study using propensity score matching.
(PubMed, Front Cell Infect Microbiol)
- "One case of mild gastrointestinal discomfort was reported in the azvudine group. Azvudine significantly reduced hospitalization duration in mild-to-moderate COVID-19 patients with a favorable safety profile."
Journal • Retrospective data • Cough • Gastrointestinal Disorder • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
July 02, 2025
Impact of early and delayed azvudine administration on COVID-19 mortality: a retrospective study.
(PubMed, Sci Rep)
- "The study indicated that the benefit of azvudine seemed more significant within 8 days of symptoms onset and the administration of azvudine reduced the risk of death in adult COVID-19 patients. In the future, large randomized controlled trials (RCT) studies are needed to confirm our conclusions because of the inherent limitation of single-centre, retrospective study."
Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
June 28, 2025
Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China.
(PubMed, BMJ Open)
- P | "Among COVID-19 patients with pre-existing hypertension, the effectiveness of azvudine is not inferior to Paxlovid in reducing all-cause death and composite disease progression, with fewer adverse events."
Clinical • Journal • Real-world evidence • Retrospective data • Cardiovascular • Hypertension • Infectious Disease • Novel Coronavirus Disease
June 19, 2025
Real-world data of Azvudine-induced hepatotoxicity among hospitalized COVID-19 patients in China: a retrospective case-control study.
(PubMed, Front Pharmacol)
- "The concomitant use of antivirals [OR: 3.80 (1.47-10.1), P = 0.006] and anticoagulant drugs [OR: 3.12 (1.77-5.61), P < 0.001], particularly Ganciclovir [OR: 4.11 (1.45-12.2), P = 0.008], Low-Molecular-Weight Heparin Calcium [OR: 3.00 (1.69-5.33), P < 0.001], and Enoxaparin [OR: 2.68 (0.99-7.10), P = 0.047], were significantly associated with an increased risk of hepatotoxicity. These findings underscored the importance of monitoring liver function during Azvudine treatment and caution against concomitant use of certain medications. Further research was warranted to elucidate the mechanisms underlying Azvudine-induced hepatotoxicity and optimize clinical management strategies."
Journal • Real-world evidence • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
June 13, 2025
Azvudine Suppresses Epithelial-Mesenchymal Transition in Hepatocellular Carcinoma by Targeting the Notch-HEY Signalling Pathway.
(PubMed, Int J Mol Sci)
- "To identify the primary target of FNC, microscale thermophoresis (MST) and molecular dynamics (MD) simulations were performed, revealing that FNC directly binds to Jagged1. This study provides valuable insights into the therapeutic potential of FNC in HCC treatment and elucidates its underlying mechanisms."
Journal • Hematological Malignancies • Hepatocellular Cancer • Human Immunodeficiency Virus • Infectious Disease • Liver Cancer • Lung Adenocarcinoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Solid Tumor • CDH1 • HEY1
June 03, 2025
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Rilpivirine Tablets (RPV)
(clinicaltrials.gov)
- P1 | N=15 | Completed | Sponsor: Henan Genuine Biotech Co., Ltd.
New P1 trial
June 03, 2025
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Aluvia
(clinicaltrials.gov)
- P1 | N=15 | Completed | Sponsor: Henan Genuine Biotech Co., Ltd.
New P1 trial
June 03, 2025
A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects
(clinicaltrials.gov)
- P1 | N=40 | Recruiting | Sponsor: Henan Genuine Biotech Co., Ltd.
New P1 trial • Nephrology • Renal Disease
June 03, 2025
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Rifampicin Capsules (RIF)
(clinicaltrials.gov)
- P1 | N=15 | Completed | Sponsor: Henan Genuine Biotech Co., Ltd.
New P1 trial
June 03, 2025
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ)
(clinicaltrials.gov)
- P1 | N=15 | Completed | Sponsor: Henan Genuine Biotech Co., Ltd.
New P1 trial
June 03, 2025
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Tenofovir Alafenol Fumarate Tablets (TAF)
(clinicaltrials.gov)
- P1 | N=15 | Completed | Sponsor: Henan Genuine Biotech Co., Ltd.
New P1 trial
June 03, 2025
[14C] Mass Balance Clinical Trial of Azvudine in Healthy Male Subjects
(clinicaltrials.gov)
- P1 | N=6 | Completed | Sponsor: Henan Genuine Biotech Co., Ltd.
New P1 trial
June 03, 2025
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Dolutegravir Sodium Tablets (DTG)
(clinicaltrials.gov)
- P1 | N=15 | Completed | Sponsor: Henan Genuine Biotech Co., Ltd.
New P1 trial
May 29, 2025
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
May 28, 2025
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
May 28, 2025
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
February 24, 2025
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
May 20, 2025
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
May 15, 2025
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
May 15, 2025
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
May 15, 2025
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
May 12, 2025
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
April 21, 2025
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
April 01, 2025
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
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