azvudine (FNC) / Granlen - LARVOL DELTA

Azvudine for COVID-19 in Kidney Transplant Recipients: A Real-World Observational Study of Long-Term Renal Outcomes. (PubMed, J Clin Med) - "Coupled with its low risk of drug-drug interactions, potential immunomodulatory benefits, and superior cost-effectiveness, Azvudine could be considered a valuable therapeutic option for this high-risk population in the post-pandemic era, although these findings warrant cautious interpretation. Controlled trials are ultimately needed to confirm these observations."

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

Comparison of the permeability of RdRp inhibitors, remdesivir, molnupiravir and azvudine, in placental barrier cell models and exploration of their transport mechanisms. (PubMed, J Antimicrob Chemother) - "RDV and GS-441524 displayed low placental permeability in BeWo cells, whereas EIDD-1931 and azvudine displayed high permeability. Multiple ENTs, CNTs, OAT4, P-gp and BCRP might be involved in placental transport of RDV, GS-441524, EIDD-1931 and azvudine. These findings offer new insights into the placental transport of RdRp inhibitors during pregnancy."

Clinical • Journal • Breast Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor • SLC29A1

Cross-sectional analysis of adverse reactions of Azvudine in patients with renal impairment and network pharmacology exploration of its mechanism (ChiCTR) - P=N/A | N=320 | Recruiting | Sponsor: Zhuhai People's Hospital; Zhuhai People's Hospital

New trial • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Safety profile of azvudine in COVID-19 patients with renal impairment: a retrospective analysis. (PubMed, Front Pharmacol) - "The nomogram model demonstrated predictive performance and calibration, with an area under the curve of 0.812. These findings highlight the need for enhanced safety monitoring and potential dose adjustments when administering FNC to COVID-19 patients with renal impairment."

Journal • Retrospective data • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Azvudine (FNC), a next-generation cytidine analog with broad inhibitory activity against drug-resistant HIV-1 strains via stabilization of the reverse transcriptase catalytic complex. (PubMed, Bioorg Chem) - "FNC exhibited sub-nanomolar potency (EC50 = 0.0812-0.1596 nM) across diverse HIV-1 subtypes, achieving up to 3000-fold higher antiviral activity than lamivudine (3TC) and emtricitabine (FTC). These interactions provide a plausible structural basis for the retained potency against resistant mutants by stabilizing the catalytic complex, reducing excision, and impeding strand translocation. Collectively, these findings identify FNC as a structurally optimized cytidine analogue with broad activity against clinically relevant resistance variants, highlighting its potential as a promising candidate for next-generation HIV-1 therapy."

Journal • Human Immunodeficiency Virus • Infectious Disease

The efficacy and safety of azvudine (FNC) in phase 1 investigator-initiated study in patients with advanced solid tumors. (ASCO 2026) - P=N/A | "All CRC subjects received the triple-combination regimen of FNC, penpulimab, and fruquintinib. Overall, the combination of FNC with PD-1 and VEGFR inhibitors was safe and well-tolerated, with encouraging clinical activity in advanced/metastatic pMMR/MSS CRC."

Clinical • Metastases • P1 data • CNS Disorders • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Liver Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sleep Disorder • Solid Tumor

RNA with Azvudine Incorporated One Nucleotide Upstream of 3'-End Resists Cleavage by SARS-CoV-2 Proofreading Exonuclease. (PubMed, Res Sq) - "Furthermore, we found that the incorporation of Azvudine at the penultimate position of the RNA prevents RNA cleavage by the ExoN. These findings may provide molecular insight for the development of novel nucleotide analogs that can inhibit RdRp and resist the viral proofreading mechanism of coronaviruses."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Anti-Zika Virus Activity of Azvudine via Inhibition of RNA Replication by Its Active Triphosphate Form. (PubMed, J Med Virol) - "We further showed that FNC-TP, but not FNC, acted as a nucleoside analog to directly inhibit the RNA-dependent RNA polymerase (RdRp), preventing RNA chain elongation with an IC50 of 4.93 μM. These findings provided the first evidence of FNC's anti-ZIKV activity, revealing that its convention to FNC-TP is the key mechanism for inhibiting viral RNA synthesis and highlighting its potential as a promising anti-ZIKV agent."

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

A retrospective study on nirmatrelvir/ritonavir and azvudine in treating COVID-19 in patients with cirrhosis (APASL 2026) - No abstract available

Retrospective data • Fibrosis • Hepatology • Immunology • Infectious Disease • Novel Coronavirus Disease

A real-world retrospective analysis comparing the effectiveness of Azvudine and Nirmatrelvir/Ritonavir in COVID-19 patients with diabetes. (PubMed, Sci Rep) - No abstract available

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

Azvudine for the treatment of cancer patients with COVID-19: a multicenter, real-world, retrospective, cohort study. (PubMed, BMC Cancer) - No abstract available

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

Evaluating the effectiveness and safety of Azvudine for hospitalised patients with COVID-19 and hypertension: a multicenter retrospective cohort study. (PubMed, Sci Rep) - "No significant difference in severe AEs (≥ Grade 3) was observed between groups. These real-world findings suggest Azvudine may be a promising antiviral option for hypertensive COVID-19 patients, but further prospective trials are necessary to confirm these results."

Journal • Retrospective data • Cardiovascular • Hypertension • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Comparison of Azvudine and Nirmatrelvir-Ritonavir in Hospitalised Patients With COVID-19: A Systematic Review and Meta-Analysis. (PubMed, Rev Med Virol) - "93). These results suggest that treatment with Azvudine may provide significant clinical benefit in patients hospitalised with COVID-19."

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

Commentary: A multicenter, real-world cohort study: effectiveness and safety of Azvudine in hospitalized COVID-19 patients with pre-existing diabetes. (PubMed, Front Endocrinol (Lausanne)) - No abstract available

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

A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Zhigang Ren

New P3 trial • Hepatitis B • Infectious Disease • Inflammation

Strain-promoted azide-alkyne cycloaddition-based fluorometric detection of azvudine using DBCO-functionalized carbon dots. (PubMed, Mikrochim Acta) - No abstract available

Journal

Azvudine potently inhibits African swine fever virus replication in vitro. (PubMed, Virus Res) - "Further mechanistic studies indicated that Azvudine acts at a post-entry stage of the viral life cycle and does not directly inactivate viral particles. These findings suggest that Azvudine is a promising repurposed candidate for anti-ASFV drug development."

Journal • Preclinical

Azvudine remodels the local immunosuppressive microenvironment and exhibits sustained anti-tumor effects in combination with anti-PD-1 therapies. (PubMed, Front Med) - "FNC remodels the TME by mitigating immunosuppression and amplifying anti-tumor immunity, offering a promising strategy to augment existing immunotherapies. Further clinical evaluation is warranted to ascertain the translational potential of FNC in diverse oncologic settings."

Journal • Oncology • CALR • CD8 • HMGB1

Impact of COVID-19 in Thalassemia Patients Undergoing Hematopoietic Stem Cell Transplant Recipients (ASH 2023) - "Of the seven patients treated with medications, four were azvudine and three were nematasvir... The low infection rate and no severe cases may be due to scientific protection and timely medication. There are no special risk factors for COVID-19 infection in thalassemia patients after transplantation."

Clinical • Bone Marrow Transplantation • Genetic Disorders • Graft versus Host Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Transplantation

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 Malignancies • Infectious Disease • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases

The efficacy of azvudine in treating hospitalized COVID-19 patients: a retrospective single-center cohort analysis. (PubMed, J Thorac Dis) - "The findings show that azvudine is effective in treating hospitalized COVID-19 patients. It could be considered for therapeutic use in this patient population."

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

In vitro comparison of the susceptibilities of the same drug resistance mutations to reverse-transcriptase inhibitors of subtype B and CRF01_AE HIV-1 strains. (PubMed, Sci Rep) - "However, phenotypic analysis of reconstructed clones containing these resistance mutations revealed that CRF01_AE exhibited significantly lower sensitivity to RTIs than did subtype B. For azvudine (FNC), a novel nucleoside reverse transcriptase inhibitor (NRTI), the resistance level of CRF01_AE was significantly lower than that of subtype B. In conclusion, the same mutation affecting resistance to RTIs can have significantly different impacts depending on the subtype of the HIV-1 strain. This finding serves as a reference for guiding rational drug use in the future. Moreover, relying solely on phenotypic experimental results from subtype B to evaluate resistance levels of unclear mutations in other subtypes may be inappropriate and should be approached with caution."

Clinical • Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease

Association of Azvudine with severe outcomes among hospitalized patients with COVID-19 during an omicron-dominance period in Wuhan, China: a single-center, retrospective, matched cohort study. (PubMed, BMC Infect Dis) - "During a SARS-CoV-2 Omicron variants predominant period, initiation of Azvudine could provide considerable protection against all-cause death, composite severe outcome measure, and result in a significantly shorter nucleic acid conversion time among hospitalized patients with COVID-19. A wider use of Azvudine in clinical settings should be considered."

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

Real-world efficacy of oral azvudine in hospitalized patients with COVID-19: A multicenter retrospective cohort study. (PubMed, J Infect Public Health) - "During the omicron epidemic in China, oral administration of azvudine was associated with a reduced risk of the composite outcome and all-cause mortality in COVID-19 patients."

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

Real-World Evaluation Study of Azvudine for the Treatment of Patients With COVID-19: A Systematic Review and Meta-Analysis. (PubMed, Can J Infect Dis Med Microbiol) - "The incidence of AEs in the Azvudine group and the Nirmatrelvir/Ritonavir group was 4.13% (60/1453) and 5.08% (67/1319), respectively, indicating that Azvudine significantly reduced the incidence of AEs compared to Nirmatrelvir/Ritonavir (OR: 0.68, 95% CI: 0.47, 0.98). In terms of safety, Azvudine demonstrated a favorable safety profile (GRADE: moderate-certainty evidence because of suspected publication bias and residual confounding). Further large-scale studies are needed to validate its efficacy and safety."

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