[1] FDA. Highlights of prescribing information. 2018, 10, 24. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbll.pdf
[2] Takashita, E.; Morita, H.; Ogawa, R.; Nakamura, K.; Fujisaki, S.; Shirakura, M.; Kuwahara, T.; Kishida, N.; Watanabe, S.; Odagiri, T. Susceptibility of influenza viruses to the novel cap-dependent endonuclease inhibitor baloxavir marboxil. Front Microbiol. 2018, 9, 3026.
[3] Gonzalez-Motos, V.; Jurgens, C.; Ritter, B.; Kropp, K.A.; Durán,V.; Larsen,O. Varicella zoster virus glycoprotein C increases chemokine-mediated leukocyte migration. PLoS Pathog. 2017, 13, e1006346.
[4] Reich, S.; Guilligay, D.; Pflug, A.; Malet, H.; Berger, I.; Crépin, T.; Hart, D.; Lunardi, T.; Nanao, M.; Ruigrok, R.W.; Cusack, S. Structural insight into cap-snatching and RNA synthesis by influenza polymerase. Nature. 2014, 516, 361–366.
[5] Shi, F.Y.; Xie, Y.C.; Shi, L.F.; Xu, W.F. Viral RNA polymerase: a promising antiviral target for influenza A virus. Curr. Med. Chem. 2013, 20, 3923–3934.
[6] Dias, A.; Bouvier, D.; Crépin, T.; McCarthy, A.A.; Hart, D.J.; Baudin, F.; Cusack, S.; Ruigrok, R.W. The cap-snatching endonuclease of influenza virus polymerase resides in the PA subunit. Nature. 2009, 458, 914–918.
[7] Locke, S.C.; Splawn, L.M.; Cho, J.C. Baloxavir marboxil: a novel cap-dependent endonuclease (CEN) inhibitor for the treatment of acute uncomplicated influenza. Drugs Today. 2019, 55, 359–366.
[8] Noshi, T.; Kitano, M.; Taniguchi, K.; Yamamoto, A.; Omoto, S.; Baba, K.; Hashimoto, T.; Ishida, K.; Kushima, Y.; Hattori, K.; Kawai, M.; Yoshida, R.; Kobayashi, M.; Yoshinaga, T.; Sato, A.; Okamatsu, M.; Sakoda, Y.; Kida, H.; Shishido, T.; Naito, A. In vitro characterization of baloxavir acid, a first-in-class cap-dependent endonuclease inhibitor of the influenza virus polymerase PA subunit. Antiviral Res. 2018, 160, 109–117.
[9] Heo, Y.A. Baloxavir: first global approval. Drugs. 2018, 78, 693–697.
[10] Watanabe, A.; Ishida, T.; Hirotsu, N.; Kawaguchi, K.; Ishibashi, T.; Shishido, T.; Sato, C.; Portsmouth, S.; Tsuchiya, K.; Uehara, T. Baloxavir marboxil in Japanese patients with seasonal influenza: Dose response and virus type/subtype outcomes from a randomized phase 2 study. Antiviral Res. 2019, 163, 75–81.
[11] Koshimichi, H.; Ishibashi, T.; Kawaguchi, N.; Sato, C.; Kawasaki, A.; Wajima, T. Safety, tolerability, and pharmacokinetics of the novel anti-influenza agent baloxavir marboxil in healthy adults: phase I study findings. Clin. Drug Investig. 2018, 38, 1189–1196.
[12] Kitano, M.; Matsuzaki, T.; Oka, R.; Baba, K.R.; Noda, T.; Yoshida, Y.; Sato, K.; Yoshida, R.; Sato, A.; Kamimori, H.; Shishido, T.; Naito, A.A. Therapeutic effects of baloxavir marboxil against influenza A virus infection in ferrets. Open Forum Infect. Dis. 2018, 5, S413.
[13] Cole, P. Baloxavir marboxil. Drugs Future. 2018, 43, 379–387.
[14] Hayden, F.G.; Sugaya, N.; Hirotsu, N.; Lee, N.; de Jong, M.D.; Hurt, A.C.; Ishida, T.; Sekino, H.; Yamada, K.; Portsmouth, S.; Kawaguchi, K.; Shishido, T.; Arai, M.; Tsuchiya, K.; Uehara, T.; Watanabe, A.; Baloxavir Marboxil Investigators Group. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N. Engl. J. Med. 2018, 379, 913–923.
[15] Nair, H.; Brooks, W.A.; Katz, M.; Roca, A.; Berkley, J.A.; Madhi, S.A.; Simmerman, J.M.; Gordon, A.; Sato, M.; Howie, S.; Krishnan, A.; Ope, M.; Lindblade, K.A.; Carosone-Link, P.; Lucero, M.; Ochieng, W.; Kamimoto, L.; Dueger, E.; Bhat, N.; Vong, S.; Theodoratou, E.; Chittaganpitch, M.; Chimah, O.; Balmaseda, A.; Buchy, P.; Harris, E.; Evans, V.; Katayose, M.; Gaur, B.; O’Callaghan-Gordo, C.; Goswami, D.; Arvelo, W.; Venter, M.; Briese, T.; Tokarz, R.; Widdowson, M.A.; Mounts, A.W.; Breiman, R.F.; Feikin, D.R.; Klugman, K.P.; Olsen, S.J.; Gessner, B.D.; Wright, P.F.; Rudan, I.; Broor, S.; Simões, E.A.; Campbell, H. Global burden of respiratory infections due to seasonal influenza in young children: a systematic review and meta-analysis. Lancet. 2011, 378, 1917–1930.
[16] Kawaguchi, K.; Portsmouth, S.; Shishido, T.; Uehara, T.; Hayden, F. Exploring clinical and antiviral efficacy of baloxavir marboxil in a phase 3, randomized, double-blind, placebo- and active-controlled study of otherwise healthy adults/adolescents in seasonal influenza: impact on regional participants, treatment time and influenza type B virus infection (CAPSTONE-1 study). Open Forum Infect. Dis. 2018, 5, S48.
[17] Shionogi. Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications (CAPSTONE2). 2018, 07, 24. 2019, 02, 15. https//clinicaltrials.gov/ct2/show/NCT02949011term=Baloxavir+marboxil
[18] Ison, M.G. Phase 3 trial of baloxavir marboxil in high risk influenza patients (CAPSTONE-2 study). Open Forum Infect. Dis. 2018, 5, S764–S765.
[19] Japan Pharmaceuticals and Medical Devices Comprehensive Agency. Xofluza tablets. 2018, 02, 23. http://www. pmda.go.jp/PmdaSearch/iyaku Detail/Result Data Set PDF/340018_6250047F1022_1_01
[20] Drug Evaluation Department, Drug Safety and Environ-mental Health Bureau, Ministry of Health, Labour and Welfare, Japan. Ask Fruzac shackle review report. 2018, 02, 08. http://101.96.10.63/www.pmda.go.jp/drugs/2018/P20180312001/340018000_23000AMX00434000_ A100_1.pdf |