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

Use of baloxavir as adjunctive antiviral therapy to neuraminidase inhibitors in severely immunocompromised individuals infected with influenza. (PubMed, Antimicrob Agents Chemother) - "We report a case series of severely immunocompromised hematology patients, including allogeneic hematopoietic cell transplantation (HCT) recipients, treated with both baloxavir and oseltamivir and describe clinical and virological outcomes and the safety profile of prolonged combination therapy. No definitive conclusions on the efficacy of this approach could be drawn from this study. More data are required on the best treatment of hematology patients infected with influenza."

Journal • Hematological Disorders • Infectious Disease • Influenza • Respiratory Diseases • Transplantation

In silico evaluation of FDA-approved antivirals and corticosteroids against SARS-CoV-2. (PubMed, Sci Rep) - "The work provides computational insights into the binding mechanisms of pharmaceutical drugs Baloxavir Marboxil (BM), Dexamethasone (DM), and Remdesivir (RD) with SARS-CoV-2 protein using molecular docking, molecular dynamics (MD) simulations, and density functional theory (DFT) analyses. The remaining medications, BM and DM can be said to show promise as antiviral treatments in the context of RD. All metrics form MD simulations and molecular docking, DFT, and ADMET evaluations confirm their appropriateness, highlighting their potential for additional research."

FDA event • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Assessment of a baloxavir marboxil treatment protocol for high pathogenicity avian influenza in Okinawa Rails, an endangered species endemic to Japan. (PubMed, PLoS One) - "Furthermore, plasma concentrations were maintained at therapeutically relevant levels up to 24 hours after subcutaneous administration at 7.5 mg/kg, with mild and reversible injection site irritation the main adverse effect. Based on these results, subcutaneous administration of BXM is proposed as a viable treatment protocol for HPAI in the conservation of endangered Okinawa rails."

Journal • Infectious Disease • Influenza • Respiratory Diseases

A double-blind randomised controlled trial on baloxavir marboxil and flufenamic acid combination for severe hospitalised influenza infection (ESCMID Global 2026) - No abstract available

Clinical • Late-breaking abstract • Infectious Disease • Influenza • 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

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

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

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

Psychiatric Symptoms after H1N1 Influenza Treated with Baloxavir Marboxil in Two Patients with Hematologic Malignancies. (PubMed, Mediterr J Hematol Infect Dis) - No abstract available

Journal • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Oncology • Psychiatry • Respiratory Diseases

Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: Tianjin Medical University | Trial completion date: Oct 2027 ➔ May 2028 | Initiation date: Mar 2026 ➔ Aug 2026 | Trial primary completion date: Sep 2027 ➔ Mar 2028

Real-world evidence • Trial completion date • Trial initiation date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Influenza • Pulmonary Disease • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P3 | N=10000 | Recruiting | Sponsor: UMC Utrecht | Phase classification: P4 ➔ P3 | N=7100 ➔ 10000 | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2021 ➔ Dec 2023

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P4 | N=6800 | Recruiting | Sponsor: MJM Bonten | N=4000 ➔ 6800 | Trial completion date: Feb 2019 ➔ Jun 2022 | Trial primary completion date: Feb 2019 ➔ Dec 2021 | Initiation date: Dec 2015 ➔ Apr 2016

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P4 | N=7100 | Recruiting | Sponsor: MJM Bonten | Trial completion date: Jun 2022 ➔ Dec 2023

Trial completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P4 | N=4000 | Recruiting | Sponsor: UMC Utrecht

New P4 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P3 | N=10000 | Recruiting | Sponsor: UMC Utrecht | Trial completion date: Dec 2025 ➔ Feb 2028 | Trial primary completion date: Dec 2023 ➔ Feb 2026

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P3 | N=20000 | Recruiting | Sponsor: UMC Utrecht | N=10000 ➔ 20000

Enrollment change • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Summary of WHO clinical practice guidelines for influenza. (PubMed, BMJ) - "apply to seasonal influenza and zoonotic influenza. There are 29 recommendations; 21 related to antiviral medications and six to adjunctive therapies to prevent and treat influenza. Recommendations are stratified by severity of disease and risk of disease progression. For seasonal influenza, WHO conditionally recommends treatment within 48 hours of symptom onset with oseltamivir for severe illness, and baloxavir for patients at high risk of progression from non-severe to severe illness. WHO also conditionally recommends prophylaxis (using baloxavir, laninimavir, oseltamivir, or zanamivir) for anyone exposed to zoonotic influenza, and for those exposed to seasonal influenza who are at extremely high risk. The panel issued recommendations against the use of adjunctive therapies in patients with non-severe influenza (strong recommendation against antibiotics) and severe influenza (conditional recommendation against corticosteroids, macrolides, mTOR inhibitors, non-steroidal..."

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

Report on influenza viruses received and tested by the Melbourne WHO Collaborating Centre for Reference and Research on Influenza during 2024. (PubMed, Commun Dis Intell (2018)) - "Of 4,007 samples tested for susceptibility to the neuraminidase inhibitors oseltamivir and zanamivir, twelve A(H1N1)pdm09 viruses and one B/Victoria virus showed highly reduced inhibition against oseltamivir or zanamivir. Of 3,294 total samples sequenced for baloxavir susceptibility, 18 of the 1,825 A(H3N2) samples were identified with genetic evidence of reduced susceptibility to baloxavir marboxil in the PA gene."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Baloxavir alleviates severe disease and viremia in ferrets infected with avian- or bovine-origin influenza A(H5N1) virus. (PubMed, Sci Transl Med) - "Baloxavir is a single-dose drug for treating seasonal influenza. We show that multidose regimens of baloxavir may be most efficacious against highly pathogenic avian influenza A(H5N1) in a preclinical ferret model, with effective control of both severe disease and neurological involvement."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Establishment of an at-line nanofractionation-based screening platform for rapid identification of influenza PAN/PAN I38T inhibitors from Artemisiae Argyi Folium. (PubMed, J Pharm Anal) - "Among them, three compounds (cynarine, isochlorogenic acid B, and isochlorogenic acid C) showed comparable inhibitory activity against PAN and even better activity against PAN I38T, compared to baloxavir. This study not only established a novel high-throughput ANF-based PANIs screening platform, but also proved the feasibility to discover PANIs from complex traditional Chinese medicines (TCMs), which has a great potential in future anti-influenza drug discovery."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Evaluating the Health Economic Impacts of Baloxavir Marboxil and Oseltamivir for the Treatment of Influenza in Adult Outpatients in Hong Kong: A Cost-Effectiveness Analysis. (PubMed, Influenza Other Respir Viruses) - "As a result, baloxavir could potentially be considered as the influenza agent of choice over oseltamivir in Hong Kong, despite a higher acquisition cost. Therefore, we recommended that integrating baloxavir into the Hospital Authority Drug Formulary in Hong Kong could enhance healthcare resource allocation and improve patient outcomes."

HEOR • Journal • Infectious Disease • Influenza • Respiratory Diseases

Baloxavir outperforms oseltamivir, favipiravir, and amantadine in treating lethal influenza A(H5N1) HA clade 2.3.4.4b infection in mice. (PubMed, Nat Commun) - "Although all drugs inhibited A(H5N1) viruses in vitro, in vivo correlations did not extend beyond baloxavir. Our results indicate that baloxavir is the most reliable treatment to address both respiratory replication and systemic spread of contemporary A(H5N1) viruses in mice and should be considered in pandemic planning."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Comparison of baloxavir/marboxil treatment and treatment with other anti-influenza agents in adult patients hospitalized for influenza: An internet-based, prospective, multicenter, cohort study in Japan. (PubMed, J Infect Chemother) - "BXM was used for patients with secondary bacterial pneumonia, although their general conditions were better, and antibiotic use was similar, although more anti-influenza agents were used than in non-BXM-treated patients. BXM might be one of the treatment options for severe influenza patients requiring hospitalization in the real world."

Journal • Infectious Disease • Influenza • Pneumonia • Respiratory Diseases

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

Anti-influenza drugs targeting trimeric RNA polymerase complex: From development to clinics. (PubMed, Acta Pharm Sin B) - "By 2025, six FluPol-targeting drugs have received regulatory approval: the PA inhibitors baloxavir marboxil, suraxavir marboxil, seloxavir marboxil, and pixavir marboxil; the PB1 inhibitor favipiravir; and the PB2 inhibitor onradivir, with several additional candidates progressing to clinical research. This review summarizes the structure and function of influenza polymerase and the mechanisms of action of different inhibitors, highlighting the discovery and clinical effectiveness of the newly approved FluPol-targeting drugs. It addresses the potential of FluPol inhibitors against highly pathogenic avian influenza and the challenges posed by resistance mutations."

Journal • Review • Infectious Disease • Influenza • Respiratory Diseases