Trial reportClinical drug investigation2018
Safety, Tolerability, and Pharmacokinetics of the Novel Anti-influenza Agent Baloxavir Marboxil in Healthy Adults: Phase I Study Findings.
Trial report in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed.
- A first-in-human phase I study to evaluate the safety, tolerability, and pharmacokinetics of a novel anti-influenza agent suraxavir marboxil in healthy Chinese subjects.Antimicrobial agents and chemotherapy · 2025Trial
- Pharmacokinetics, safety, and simulated efficacy of an influenza treatment, baloxavir marboxil, in Chinese individuals.Clinical and translational science · 2022Trial
- 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.Emerging microbes & infections · 2026Article
- Population Pharmacokinetics and Exposure-Response Analysis of Oral Pixavir Marboxil in Adults and Adolescents with Influenza.Pharmaceutics · 2026Article
- Baloxavir Exhibits Antibacterial Activity AgainstInternational journal of molecular sciences · 2026Article
- A scoping review of influenza RdRp-targeting inhibitors: mechanisms, clinical translation, and emerging challenges.Frontiers in microbiology · 2026Review
- A cap-dependent endonuclease inhibitor acts as a potent antiviral agent against La Crosse virus infection.Antimicrobial agents and chemotherapy · 2025Article
- Safety evaluation of baloxavir marboxil: analysis and discussion utilizing real adverse events from the FAERS database.BMC pharmacology & toxicology · 2025Article
- Inhibition of cap-dependent endonuclease in influenza virus with ADC189: a pre-clinical analysis and phase I trial.Frontiers of medicine · 2025Article
- Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs.The AAPS journal · 2024Review
- Prophylactic Treatment with Baloxavir Protects Mice from Lethal Infection with Influenza A and B Viruses.Viruses · 2023Article
- Antiviral Approaches against Influenza Virus.Clinical microbiology reviews · 2023Review
- In Silico Drug Repurposing of FDA-Approved Drugs Highlighting Promacta as a Potential Inhibitor of H7N9 Influenza Virus.Molecules (Basel, Switzerland) · 2022Article
- Drug update - Baloxavir marboxil: Latest entrant into the arena of pharmacotherapy of influenza.Medical journal, Armed Forces India · 2022Review
- Broad-Spectrum Activity of Small Molecules Acting against Influenza a Virus: Biological and Computational Studies.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Pharmacokinetics and safety of a novel influenza treatment (baloxavir marboxil) in Korean subjects compared with Japanese subjects.Clinical and translational science · 2022Article
- Mesenchymal stem/stromal cell-based therapies for severe viral pneumonia: therapeutic potential and challenges.Intensive care medicine experimental · 2021Review
- Baloxavir Marboxil: An Original New Drug against Influenza.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Baloxavir Treatment Delays Influenza B Virus Transmission in Ferrets and Results in Limited Generation of Drug-Resistant Variants.Antimicrobial agents and chemotherapy · 2021Article
- Substitution of I222L-E119V in neuraminidase from highly pathogenic avian influenza H7N9 virus exhibited synergistic resistance effect to oseltamivir in mice.Scientific reports · 2021Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveBaloxavir marboxil, a prodrug that is metabolized to baloxavir acid, suppresses viral replication by inhibiting cap-dependent endonuclease. This first-in-human phase I study evaluated the safety, tolerability, and pharmacokinetics of baloxavir marboxil/baloxavir acid in healthy Japanese volunteers (Study 1), while food effects were evaluated in a separate phase I, crossover study in healthy Japanese volunteers (Study 2).
methodsStudy 1 participants were randomized to single-dose oral baloxavir marboxil (6, 20, 40, 60, or 80 mg; n = 6 per dose) or placebo (n = 10), while Study 2 participants (n = 15) received single-dose oral baloxavir marboxil 20 mg in fasted, fed, and before-meal states.
resultsBaloxavir marboxil was well tolerated; there were few treatment-emergent adverse events and no serious adverse events/deaths. The mean plasma baloxavir acid concentration 24 h after single-dose (C
conclusionSingle-dose oral baloxavir marboxil was well tolerated, had a favorable safety profile, and had favorable pharmacokinetic characteristics, including a long half-life, supporting single oral dosing. The baloxavir acid area under the plasma concentration-time curve decreased with food intake by approximately 40%.
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