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

Impaired host shutoff is a fitness cost associated with baloxavir marboxil resistance mutations in influenza A virus PA/PA-X nuclease domain. (PubMed, PLoS Pathog) - "Most importantly, we also demonstrate that the I38T/M mutations significantly impair the host shutoff activity of PA-X proteins from different IAV strains of H1N1, H3N2, and H5N1 subtypes. Our work reveals that the deleterious effects of I38T/M on PA-X function may represent an important barrier to the spread of BXM-resistant viruses."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD: A Prospective Cohort Study (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: Tianjin Medical University

New trial • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Influenza • Pulmonary Disease • Respiratory Diseases

Oseltamivir and baloxavir monotherapy and combination therapy efficacy against clade 2.3.4.4b A(H5N1) influenza virus infection in ferrets. (PubMed, Commun Biol) - "Combination OST/BXA treatment, when administered pre- or post-symptom onset, resulted in significant improvements in both metrics versus OST monotherapy. These data support continued investigation of antiviral treatment modalities that include both NAI and CENI for patients with mild and severe A(H5N1) disease."

Journal • Monotherapy • Infectious Disease • Influenza • Respiratory Diseases

A cost-effectiveness analysis of baloxavir marboxil versus oseltamivir for seasonal influenza treatment in China. (PubMed, Front Pharmacol) - "Baloxavir is a cost-effective alternative to oseltamivir for seasonal influenza treatment in China. It can improve patient outcomes and reduce influenza transmission at a societal level, offering value to the healthcare system."

HEOR • Journal • Infectious Disease • Influenza • Respiratory Diseases

Population Pharmacokinetic and Exposure-Efficacy Analysis of Baloxavir Marboxil for Influenza Treatment and Post-Exposure Prophylaxis in Children. (PubMed, Clin Pharmacol Ther) - P3 | "To bridge PEP efficacy data from the BLOCKSTONE study in Japanese pediatric patients (JapicCTI-184,180) to non-Asian patients aged ≥1 year, an exposure-matching approach between Japanese pediatric patients receiving the lower BLOCKSTONE dose and non-Asian pediatric patients receiving the miniSTONE-2 dose was employed. Together, these observations indicate that the recommended miniSTONE-2 dosing regimen is likely to be efficacious for treatment and PEP in children aged 1-<12 years, regardless of race."

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

V-domain immunoglobulin suppressor of T-cell activation regulates CD4+ T cell activation and podocyte function through PI3K/AKT signaling pathway. (PubMed, Biomed Pharmacother) - "Moreover, previously demonstrated VISTA agonist Baloxavir marboxil decreased renal CD4+ T cells, restored the expression of Nephrin and Podocin, and promoted autophagy. Our study suggests that VISTA plays an important role in the pathogenesis of LN, which offers novel mechanisms and potential target for its application in LN therapy."

Journal • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • CD4 • CD40LG • IFNG • IL17A • NPHS1

Antiviral efficacy of baloxavir marboxil, favipiravir, and oseltamivir in adults with acute non-severe influenza virus infection: an open-label, phase II, randomised, controlled, adaptive platform trial (ESCMID Global 2026) - No abstract available

Clinical • P2 data • Infectious Disease • Influenza • Respiratory Diseases

Evaluating baloxavir and oseltamivir for influenza: a real-world comparison of hospitalisation risk and safety (ESCMID Global 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease • Influenza • Respiratory Diseases

Influenza PA Substitutions and Genetic Diversity of A(H1N1)pdm09, A(H3N2), and B/Victoria Viruses in Japan During the 2023-2024 Season. (PubMed, Viruses) - "NA genes showed no substitutions associated with reduced susceptibility to laninamivir (e.g., E119A, G147E). Although pre-treatment PA/I38T was absent, low-frequency on-therapy selection was observed, including a rare PA/I38T in influenza B/Victoria detected by NGS, suggesting the value of deep sequencing when viral loads are low. These integrated genomic-clinical data support vaccine strain realignment for H3N2 and continued monitoring of baloxavir resistance in outpatient care."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Comprehensive evaluation of therapeutic effectiveness and safety profiles of baloxavir marboxil for managing influenza virus infection in pediatric populations: a systematic review with pooled meta-analytic data. (PubMed, Front Pediatr) - "A random-effects model meta-analysis demonstrated that, compared to neuraminidase inhibitors (oseltamivir, zanamivir, peramivir, laninamivir), baloxavir marboxil achieved accelerated resolution of febrile symptoms (MD = -13.16 h, 95% CI: -19.16 to -7.15, P < 0.0001)...However, continuous monitoring for baloxavir-resistant mutations (such as PA/I38T) in the pediatric population is warranted. Furthermore, confirmation through large-scale multicenter trials with extended follow-up periods remains warranted."

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

Emergence of the novel PA-D27G mutation conferring reduced baloxavir susceptibility in influenza A viruses circulating in China, 2018-2025 (ESCMID Global 2026) - No abstract available

Infectious Disease • Influenza • Respiratory Diseases

A sequence-based update on mutations in influenza polymerase acidic protein in Europe conferring resistance to baloxavir from 2009 to 2025: the old, the new, and the emerging mutations (ESCMID Global 2026) - No abstract available

Infectious Disease • Influenza • Respiratory Diseases

Disproportionality analysis and "perpetrator" or "accomplice" review of Baloxavir marboxil in public FAERS database. (PubMed, BMC Infect Dis) - No abstract available

Journal • Infectious Disease • Influenza • Respiratory Diseases

TMPRSS2 inhibitors with broad-spectrum efficacy against SARS-CoV-2 (JN.1) and influenza A (H1N1) viruses protect mice from influenza A infection. (PubMed, Emerg Microbes Infect) - "Compound 9 displayed a synergistic effect with baloxavir during IAV H1N1 infection. Both compounds highly reduced H1N1 infection in air-liquid interface cultures and mouse models, thus highlighting their broad antiviral potential. The discovery of broad-spectrum, host-directed antivirals against current and emerging human viruses is critical in preparing for future pandemics."

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

Emergence of the novel PA-D27G mutation conferring reduced baloxavir susceptibility in influenza A viruses circulating in China, 2018-2025. (PubMed, Emerg Microbes Infect) - "Epidemiological analysis showed that D27G mutation remained rare, being detected in four isolates (4/1247, 0.32%) in mainland China, and at a sporadic prevalence (<0.1%, 9/53,132) across global isolates. In conclusion, these results demonstrate the early emergence of BXM-associated resistance in China and identify PA-D27G as a resistance-associated mutation with preserved viral fitness, underscoring the importance of continued genomic and epidemiologic surveillance."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Clinical Features and Management of a Critical Human Case of H10N3 Avian Influenza: A Case Report and Literature Review. (PubMed, Int J Infect Dis) - "Due to its nonspecific early symptoms, H10N3 is difficult to diagnose promptly, increasing the risk. Early recognition, antiviral therapy, and aggressive support are essential in managing severe infections."

Journal • Cough • Infectious Disease • Influenza • Pneumonia • Respiratory Diseases

Baloxavir susceptibility of seasonal influenza viruses during the first seven seasons of clinical use in Japan, 2017/18 to 2023/24. (PubMed, Euro Surveill) - "Our findings suggest a possible association between the extent of baloxavir use and the emergence of resistance and highlight how circulating subtypes shape seasonal susceptibility profiles. Although reduced susceptibility to baloxavir remains relatively rare, emergence of transmissible virus variants emphasises the need for continued phenotypic and genotypic surveillance to guide treatment strategies, support public health preparedness, and prevent the spread of resistant viruses."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) (clinicaltrials.gov) - P3 | N=264 | Not yet recruiting | Sponsor: Unity Health Toronto

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Influenza B-Associated Mild Encephalopathy with Reversible Splenial Lesion in an Adult: A Case Report. (PubMed, Neurol Int) - "This case report of an influenza B-triggered MERS in an adult highlights the importance of maintaining MERS as a differential for acute encephalopathy in adults with a viral prodrome."

Journal • CNS Disorders • Epilepsy • Infectious Disease • Inflammation • Influenza • Metabolic Disorders • Pain • Pediatrics • Respiratory Diseases

Characterization of minigenome systems for Hantaan and Seoul hantaviruses. (PubMed, Virus Res) - "All the compounds tested (2'-deoxy-2'-Fluorocytidine, baloxavir, remdesivir and ribavirin) show potent anti-HTNV activity. The minigenome systems could be useful tools to study replication mechanisms and to screen antiviral compounds against hantaviruses at lower containment laboratories."

Journal • Hematological Disorders • Infectious Disease • Nephrology • Renal Disease • Respiratory Diseases

Identification and characterization of a novel inhibitor of influenza A virus that acts by blocking nucleoprotein oligomerization. (PubMed, Antimicrob Agents Chemother) - "Importantly, VNT-101 remains active against influenza variants that are resistant to either oseltamivir or baloxavir and also has potent activity against highly pathogenic avian H5N1 and H7N9 isolates that have transmitted to humans and represent strains of potential pandemic concern. These studies support the continued development of VNT-101 to augment our therapeutic arsenal against both seasonal and pandemic influenza."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Antiviral susceptibility of clade 2.3.4.4b highly pathogenic avian influenza A(H5N1) viruses from humans in the United States, October 2024 to February 2025. (PubMed, Emerg Microbes Infect) - "Except for two, viruses from human cases were assessed as susceptible to antivirals and confirmed by in vitro susceptibility testing of representative viruses with M2 blockers, neuraminidase (NA) inhibitors, and the polymerase acidic (PA) inhibitor baloxavir...Using recombinant NA proteins generated from B3.13 and D1.1 backgrounds, we showed that among mutations that reduced susceptibility of NA inhibitors, only NA-H275Y had no effect on the enzyme's function. Spontaneous emergence of drug-resistant influenza viruses, especially those that maintain replicative fitness, pose persistent threat to human health and must be closely monitored."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Comparison of Post-Marketing Serious Outcomes with Neuraminidase Inhibitors and Baloxavir Use in Influenza (ASHP 2025) - No abstract available

P4 data • Infectious Disease • Influenza • Respiratory Diseases

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