Xofluza (baloxavir marboxil) / Roche, Shionogi - LARVOL DELTA

Evaluation of combining the PDX analogue AN-137B with oseltamivir in a mouse model of severe influenza A (H1N1) infection. (PubMed, Antivir Ther) - "We recently reported that the combination of AN-137B, a molecular analogue of PDX, with oseltamivir or baloxavir provided synergism/additive effects against influenza, in vitro. In the latter group, the mean lung viral titre (LVT), as determined by plaque assay (2.53 ± 0.63 × 105 PFU/mL) and by qRT-PCR (2.39 ± 1.3 × 108 copies/mL), was significantly lower than that of the untreated group (4.76 ± 0.9 × 105 PFU/mL and 3.75 ± 0.86 × 108 copies/mL (p < .05), contrasting with LVTs of animals that received single therapies. These in vivo results reinforce the potential of AN-137B when combined to a potent anti-influenza agent against severe influenza."

Journal • Preclinical • Infectious Disease • Inflammation • Influenza • Respiratory Diseases • PD-1

Comparison of clinical outcomes of oseltamivir versus baloxavir in outpatients with influenza: a retrospective cohort analysis. (PubMed, Int J Infect Dis) - "Conclusions The outpatients with treatment of baloxavir have lower hospitalization rates and emergency department visits. Mortality rates were nearly identical between groups, showing no significant difference."

Clinical data • Journal • Retrospective data • Infectious Disease • Influenza • Respiratory Diseases

A literature review of influenza chemoprophylaxis and treatment in children. (PubMed, Germs) - "In Europe, oseltamivir, zanamivir, and baloxavir marboxil are recommended for the treatment or prophylaxis of influenza in adults and children, while the Food and Drug Administration added intravenous peramivir to the list of anti-influenza drugs...However, there are still discussions related to the duration of prophylaxis, with shorter periods of administration being explored, or the most efficient treatment dosage program (whether it is the conventional dosage of 3 mg/kg/dose for children <40 kg or 75 mg for adults, twice daily, compared to a double dosage administration program). When faced with an old disease, it is essential to constantly assess the efficacy of conventional molecules and dosages, along with new antivirals or complementary medication."

Journal • Review • Infectious Disease • Influenza • Pediatrics • Respiratory Diseases

The Republic of Korea 2023-2024 Influenza and Respiratory Viruses Laboratory Surveillance Report (PubMed, Jugan Geongang Gwa Jilbyeong) - "Further, no mutations associated with resistance to antiviral drugs (Oseltamivir, Zanamivir, and Peramivir, Baloxavir) were identified...The continuous surveillance of influenza and respiratory virus trends is essential to inform vaccine strain selection and enhance public health response strategies. Our division will conduct continuous surveillance of the epidemiological trends of respiratory viruses, including influenza, and ensure the timely provision of data for public health interventions."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Antiviral treatment in adult patients hospitalized for influenza: study protocol for a multi-center, randomized, placebo-controlled trial on the efficacy of baloxavir marboxil to reduce time to clinical improvement and the risk for severe complications (the INFLUENT trial). (PubMed, Trials) - P3 | "This trial's results, whether positive or negative, will impact clinical guidance. If baloxavir's clinical benefit is demonstrated, a single-dose pill would be the easiest implementable treatment option in case of large seasonal outbreaks or a new influenza pandemic. If a clear treatment benefit is not shown, antiviral treatment administration in the hospitalized patient population could be reconsidered to prevent unnecessary medication, lower the risk of resistance development linked to treatment overuse, and ultimately save unnecessary treatment-related expenses."

Clinical • Clinical protocol • Journal • Infectious Disease • Influenza • Respiratory Diseases

Longitudinal [18F]FDG-PET/CT as a Prognostic Tool for Influenza-Induced Lung Inflammation and Therapy Response in Mice (APSR 2025) - "Methods : Immunocompetent mice were intranasally inoculated with a lethal dose of influenza A virus (H1N1 Puerto Rico|8|34 strain) and subsequently treated with either antiviral agents (baloxavir or favipiravir) or vehicle control. Conclusion : Lung [18F]FDG uptake is a non-invasive imaging biomarker of pulmonary inflammation in influenza, providing early insights into antiviral treatment efficacy. By quantifying inflammatory responses, [18F]FDG-PET offers a valuable tool for rapid preclinical assessment of novel or repurposed influenza therapeutics, potentially acceleration drug development."

FDG PET • Preclinical • Infectious Disease • Inflammation • Influenza • Pneumonia • Pulmonary Disease • Respiratory Diseases

Clinical outcomes of baloxavir marboxil versus oseltamivir in outpatients aged 1 to under 5 years in China: a multicenter, retrospective cohort study. (PubMed, J Infect Chemother) - "BXM, the single-dose oral regimen, has demonstrated comparable effectiveness to OSV in terms of influenza-related return visits and hospitalization rates."

Clinical data • Journal • Retrospective data • Infectious Disease • Influenza • Respiratory Diseases

WITHDRAWN Longitudinal 18F-FDG-PET/CT as a Prognostic Tool for Influenza-induced Lung Inflammation and Therapy Response in Mice (ASTMH 2025) - "Immunocompetent mice were infected with a lethal dose of influenza A /H1N1 PR8 and subsequently treated with either antiviral agents (baloxavir or favipiravir) or vehicle control. Most importantly, lung FDG correlates with inflammatory markers in the lung but not with viral burden in the tissue, confirming that lung FDG uptake reflects the inflammatory processes triggered by influenza and the reduction of inflammation resulting from effective treatment. By quantifying inflammatory responses, FDG-PET offers a valuable tool for rapid preclinical assessment of novel or repurposed influenza therapeutics, potentially acceleration drug development."

FDG PET • Preclinical • Infectious Disease • Inflammation • Influenza • Pneumonia • Pulmonary Disease • Respiratory Diseases

Comparison of the efficacy and safety of baloxavir versus those of oseltamivir in pediatric patients with influenza: a meta-analysis. (PubMed, Front Microbiol) - "Additionally, the safety profiles of baloxavir and oseltamivir are comparable. https://www.crd.york.ac.uk/, CRD420251128843."

Journal • Retrospective data • Review • Infectious Disease • Influenza • Pediatrics • Respiratory Diseases

Design, synthesis and preliminary biological evaluation of novel carbamoyl pyridone derivatives as potent inhibitors of Crimean-Congo hemorrhagic fever virus. (PubMed, Eur J Med Chem) - "Compared with baloxavir acid, Z10Na showed markedly higher systemic exposure after intravenous administration and maintained prolonged persistence under oral dosing, although with limited bioavailability. These findings highlight Z10Na as promising antiviral candidates that combine structural novelty with favorable pharmacokinetic features, supporting their further optimization and in vivo validation as potential anti-CCHFV agents."

Journal • Hematological Disorders

Efficacy and Safety of Anti-Influenza Drugs in 160 Chinese Children With Influenza A: A Retrospective Study. (PubMed, J Paediatr Child Health) - "Baloxavir marboxil exhibited superior efficacy in reducing fever and shortening the illness duration. Its single-dose regimen enhances compliance with antiviral therapy, although it remains a relatively more expensive option. In contrast, oseltamivir granules enabled more accurate dosing, while oseltamivir capsules were the most cost-effective treatment."

Journal • Retrospective data • Infectious Disease • Influenza • Respiratory Diseases

Quantifying the Societal Value: Reduced Burden and Resource Savings From Baloxavir Marboxil's Influenza Transmission Protection in China (ISPOR-EU 2025) - "The analysis conducted across three population groups: pediatric patients, otherwise healthy adults, and the elderly, focusing on influenza cases averted, reductions in healthcare resource utilization, and avoided productivity losses. Compared to a scenario where influenza patients received only oseltamivir, assuming 50% of treated patients received baloxavir marboxil, its use reduced transmission across all age groups, with the most pronounced impact observed among pediatric patients. Baloxavir marboxil significantly interrupts influenza transmission, leading to substantial reductions in influenza cases, healthcare resource utilization, and influenza-associated excess mortality. These reductions translate into considerable economic and societal benefits, indicating baloxavir marboxil's value as a public health intervention in China."

Infectious Disease • Influenza • Pediatrics • Respiratory Diseases

Reducing the Transmission and Annual Burden of Influenza in the UK With Baloxavir Marboxil: A Cost-Effectiveness Analysis Using Evidence From the CENTERSTONE Trial (ISPOR-EU 2025) - P3 | "Baloxavir could prevent nearly 500,000 seasonal influenza cases in the UK and was cost-effective vs no antiviral treatment or oseltamivir."

Cost effectiveness • HEOR • Infectious Disease • Influenza • Respiratory Diseases

Discovery of a spirocyclic influenza RNA-dependent RNA polymerase inhibitor. (PubMed, Bioorg Chem) - "The cap-dependent endonuclease (CEN) inhibitor baloxavir marboxil (1) was approved by the FDA as a significant advancement in influenza treatment in nearly two decades...Moreover, both (S,S)-5a and its prodrug 6 effectively suppressed viral replication in a mouse model infected with A/WSN/33, demonstrating promising efficacy profiles. Both compound (S,S)-5a and its unique binding mode with the receptor warrant further investigation."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Efficacy of Oseltamivir Against Seasonal Influenza H1N1 and the Efficacy of a Novel Combination Treatment In Vitro and In Vivo in Mouse Studies. (PubMed, Influenza Other Respir Viruses) - "The increase in HA and NA activities of seasonal influenza reduced the efficacy of oseltamivir treatment, but the effectiveness of molnupiravir and baloxavir was retained. Combination therapy showed a significant antiviral effect, which provides a reference for the clinical treatment."

Journal • Preclinical • Infectious Disease • Inflammation • Influenza • Pneumonia • Respiratory Diseases

Epidemic season 2023-2024: the palette of ARVI pathogens in some territories of the Russian Federation and WHO regions (PubMed, Vopr Virusol) - "Against the background of a relatively low circulation of new SARS-CoV-2 variants in the 2023-2024 season, epidemic activity of influenza viruses was recorded in the countries of the Northern hemisphere at the traditional time. Globally, its onset was associated with the influenza A(H3N2) virus, followed by an increase in the activity of the influenza A(H1N1) pdm09 virus and influenza B. As in previous seasons, differences in the proportion of influenza viruses in WHO regions, including cities of the Russian Federation, were traced."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Baloxavir Marboxil in Chinese Pediatric Patients Aged 1 to < 5 Years with Influenza: Safety and Clinical and Virologic Outcomes. (PubMed, Infect Dis Ther) - P4 | "A single, oral dose of baloxavir was well-tolerated in Chinese children aged 1 to < 5 years, with rapid influenza virus clearance and associated symptom alleviation, suggesting baloxavir was an important treatment option for Chinese pediatric patients with influenza."

Journal • Infectious Disease • Influenza • Pediatrics • Pulmonary Disease • Respiratory Diseases

Comparison table: Antiviral drugs for seasonal influenza for 2025-2026. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Influenza • Respiratory Diseases

Antiviral drugs for seasonal influenza for 2025-2026. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Influenza • Respiratory Diseases

Exploring Drug Repurposing for Influenza A (H3N2) Virus: A Computational Approach to Identifying Commercialized Drugs Targeting Hemagglutinin, Neuraminidase, and Nucleoprotein. (PubMed, J Chem Inf Model) - "Despite the availability of antiviral treatments such as Oseltamivir, Zanamivir, and more recently, Baloxavir Marboxil, their efficacy is limited by resistance, side effects, and the rapid mutation of the virus...Finally, free-energy calculations were carried out to assess binding affinities, ranking the drugs based on their potential inhibitory effects and providing critical insights for their further development as antiviral treatments. This integrated computational approach offers a faster, cost-effective pathway for discovering novel influenza therapies with significant implications for pandemic preparedness."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Influenza Antiviral Pharmacokinetic-Pharmacodynamic Relationships in Pregnancy, Infancy, and Early Childhood. (PubMed, J Infect Dis) - "Owing to its decades of use among patients of all ages and health conditions, oseltamivir has the most widely described pharmacokinetics (PK) and pharmacodynamics (PD) of all the modern influenza antivirals. Even less is known regarding the PK/PD of baloxavir-the first widely available cap-dependent endonuclease inhibitor-and the role that baloxavir may have alone and in combination with neuraminidase inhibitors for treating influenza in these populations. Support for further influenza antiviral PK and PD studies is needed to diversify and bolster our arsenal so that we may better protect and treat our most vulnerable patients."

Journal • PK/PD data • Infectious Disease • Influenza • Pediatrics • Respiratory Diseases

New Developments in Influenza Polymerase Inhibitors. (PubMed, J Infect Dis) - "The cap-dependent endonuclease inhibitor baloxavir is now widely available and several other polymerase inhibitors are undergoing regulatory review. This review discusses new developments in influenza RNA polymerase inhibitors, including their mechanisms of action, pharmacokinetics, efficacy in preclinical and clinical studies, and the emergence of resistant variants. These new agents offer expanded treatment options, including antiviral combinations, and contribute to enhanced strategies for controlling influenza virus infections."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Influenza Antivirals for Prevention and Treatment in Immunocompromised People. (PubMed, J Infect Dis) - "Baloxavir is a newer antiviral that has potent effects on viral kinetics in immunocompetent people, but data on baloxavir in ICIs are currently limited...Unfortunately, ICIs have been excluded from most clinical trials evaluating novel influenza preventive and therapeutic strategies. Inclusion of ICIs in such clinical trials is essential to facilitate acquisition of clinical and virologic data in patients with specific immunocompromising conditions and ensure that ICIs have equitable access to valuable interventions."

Journal • Infectious Disease • Influenza • Respiratory Diseases • Transplantation

Modeling Influenza Antiviral Strategies: Reducing Burden and Preventing Resistance. (PubMed, J Infect Dis) - "Strategies such as suspending baloxavir use on detection of resistance or administering combination baloxavir-oseltamivir therapy could further mitigate these risks. For example, treating the same patient population with combination therapy would achieve a 33.5% reduction in DALYs lost, with a 10.2% likelihood of baloxavir resistance emergence and community transmission."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Laboratory Methods for Monitoring Influenza Antiviral Resistance. (PubMed, J Infect Dis) - "Susceptibility to neuraminidase inhibitors (NAIs) is analyzed using neuraminidase activity-based assays with small synthetic substrates, while susceptibility to baloxavir is determined using replication-based assays...Additional considerations including preclinical testing in animal models may shed further light on antiviral susceptibility related to drug exposures relevant to humans and the fitness of viruses that contain reduced drug susceptibility genotypes. This framework provides a harmonized approach for monitoring antiviral susceptibility of influenza viruses needed to inform public health responses and clinical management."

Journal • Infectious Disease • Influenza • Respiratory Diseases