Publications

  • Effect of Cefiderocol, a Siderophore Cephalosporin, on QT/QTc Interval in Healthy Adult Subjects

    Clinical Therapeutics.

    Sanabria C<sup>1</sup>, Migoya E<sup>2</sup>, Mason JW<sup>3</sup>, Stanworth SH<sup>4</sup>, Katsube T<sup>5</sup>, Machida M<sup>5</sup>, Narukawa Y<sup>5</sup>, Den Nagata T<sup>5</sup>.

    <sup>1</sup>Spaulding Clinical Research, LLC, West Bend, Wisconsin, USA; <sup>2</sup>Shionogi Inc, Florham Park, New Jersey, USA; <sup>3</sup>Mason Cardiac Safety Consulting, Reno, Nevada, USA; <sup>4</sup>Spaulding Clinical Research, LLC, West Bend, Wisconsin, USA; <sup>5</sup>Shionogi & Co, Ltd, Osaka, Japan.

  • In vivo pharmacodynamic study of cefiderocol, a novel parenteral siderophore cephalosporin, in murine thigh and lung infection models

    Antimicrobial Agents and Chemotherapy.

    Nakamura R<sup>1</sup>, Ito-Horiyama T<sup>2</sup>, Takemura M<sup>2</sup>, Toba S<sup>2</sup>, Matsumoto S<sup>2</sup>, Ikehara T<sup>2</sup>, Tsuji M<sup>2</sup>, Sato T<sup>2</sup>, Yamano Y<sup>2</sup>.

    <sup>1</sup>Drug Discovery & Disease Research Laboratory, Shionogi & Co., Ltd, Toyonaka, Osaka 561-0825, Japan; <sup>2</sup>Drug Discovery & Disease Research Laboratory, Shionogi & Co., Ltd, Toyonaka, Osaka 561-0825, Japan.

  • Effects of food and calcium carbonate on the pharmacokinetics of lusutrombopag, a novel thrombopoietin receptor agonist

    Clinical Therapeutics.

    Katsube T<sup>1</sup>, Wajima T<sup>1</sup>, Fukuhara T<sup>2</sup>, Kano T<sup>3</sup>.

    <sup>1</sup>Clinical Pharmacology & Pharmacokinetics, Shionogi & Co, Ltd, Osaka, Japan; <sup>2</sup>Clinical Research Department, Shionogi & Co, Ltd, Osaka, Japan; <sup>3</sup>Project Management Department, Shionogi & Co, Ltd, Osaka, Japan.

  • Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance

    Hepatology Research.

    Sasaki R<sup>1</sup>, Shiino C<sup>2</sup>, Imawari M<sup>3</sup>, Bentley R<sup>4</sup>, Cai B<sup>5</sup>, Yoshida M<sup>6</sup>, Afdhal N<sup>7</sup>.

    <sup>1</sup>Pharmacovigilance Department, Shionogi; <sup>2</sup>Postmarketing Surveillance & Pharmacoepidemiology Department, Shionogi Pharmacovigilance Center, and <sup>6</sup>Medical Affairs, Shionogi, Osaka; <sup>3</sup>Institute for Gastrointestinal and Liver Diseases, Shin-Yurigaoka General Hospital, Kawasaki, Japan; <sup>4</sup>Global Market Access, Shionogi; <sup>5</sup>Global Observational Research, Epidemiology and Health Outcomes, Shionogi, Florham Park, New Jersey; <sup>7</sup>Liver Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.

  • Pharmacokinetic/Pharmacodynamic Modelling and Simulation of Lusutrombopag, a Novel Thrombopoietin Receptor Agonist, for the Treatment of Thrombocytopenia in Patients with Chronic Liver Disease Undergoing Invasive Procedures

    Clinical Pharmacokinetics.

    Katsube T<sup>1</sup>, Shimizu R<sup>1</sup>, Fukuhara T<sup>2</sup>, Kano T<sup>3</sup>, Wajima T<sup>1</sup>.

    <sup>1</sup>Clinical Pharmacology and Pharmacokinetics, Shionogi & Co., Ltd, Osaka, Japan; <sup>2</sup>Clinical Research Department, Shionogi & Co., Ltd, Osaka, Japan; <sup>3</sup>Project Management Department, Shionogi & Co., Ltd, Osaka, Japan.

  • Intrapulmonary pharmacokinetics of cefiderocol, a novel siderophore cephalosporin, in healthy adult subjects

    Journal of Antimicrobial Chemotherapy.

    Katsube T<sup>1</sup>, Saisho Y<sup>2</sup>, Shimada J<sup>3</sup>, Furuie H<sup>4</sup>.

    <sup>1</sup>Clinical Pharmacology & Pharmacokinetics, Shionogi & Co., Ltd, Osaka, Japan; <sup>2</sup>Medical Affairs Department, Shionogi & Co., Ltd, Osaka, Japan; <sup>3</sup>St Marianna University School of Medicine, Kawasaki, Japan; <sup>4</sup>Osaka Pharmacology Clinical Research Hospital, Osaka, Japan.

  • Reproducibility of broth microdilution MICs for the novel siderophore cephalosporin, cefiderocol, determined using iron-depleted cation-adjusted Mueller-Hinton broth

    Diagnostic Microbiology and Infectious Disease.

    Hackel MA<sup>1</sup>, Tsuji M<sup>2</sup>, Yamano Y<sup>3</sup>, Echols R<sup>4</sup>, Karlowsky JA<sup>5</sup>, Sahm DF<sup>6</sup>.

    <sup>1</sup>International Health Management Associates, Inc., Schaumburg, Illinois, USA; <sup>2</sup>Drug Discovery & Disease Research Laboratory, Shionogi & Co., Ltd., Osaka, Japan; <sup>3</sup>Pharmaceutical Research Division, Shionogi & Co., Ltd., Osaka, Japan; <sup>4</sup>Clinical Development and Medical Affairs, ID3C, LLC, Easton, Connecticut, USA; <sup>5</sup>Department of Medical Microbiology and Infectious Diseases, College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada; <sup>6</sup>International Health Management Associates, Inc., Schaumburg, Illinois, USA.

  • Lusutrombopag for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Invasive Procedures (L-PLUS 2)

    Hepatology.

    Peck-Radosavljevic M<sup>1</sup>, Simon K<sup>2</sup>, Iacobellis A<sup>3</sup>, Hassanein T<sup>4</sup>, Kayali Z<sup>5</sup>, Tran A<sup>6,7</sup>, Makara M<sup>8</sup>, Ben Ari Z<sup>9</sup>, Braun M<sup>10</sup>, Mitrut P<sup>11</sup>, Yang SS<sup>12</sup>, Akdogan M<sup>13</sup>, Pirisi M<sup>14</sup>, Duggal A<sup>15</sup>, Ochiai T<sup>16</sup>, Motomiya T<sup>16</sup>, Kano T<sup>16</sup>, Nagata T<sup>16</sup>, Afdhal N<sup>17</sup>.

    <sup>1</sup>Abteilung Innere Medizin & Gastroenterologie, mit Zentraler Aufnahme & Erstversorgung, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria; <sup>2</sup>Department of Infectious Diseases and Hepatology, Wroclaw Medical University, Wroclaw, Poland; <sup>3</sup>Division of Gastroenterology, Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy; <sup>4</sup>Southern California Research Center, Coronado, CA; <sup>5</sup>Inland Empire Liver Foundation, University of California, Riverside, Rialto, CA; <sup>6</sup>Institut national de la santé et la recherche médicale (INSERM), Unit 1065, Centre Méditerranéen de Médecine Moléculaire (C3M), Team 8: “Chronic liver diseases associated with obesity and alcohol,” Nice, France; <sup>7</sup>Centre Hospitalier Universitaire de Nice, Digestive Center, Nice, France; <sup>8</sup>Dél-pesti Centrumkórház–Országos Hematológiai és Infektológiai Intézet, Budapest, Hungary; <sup>9</sup>Liver Disease Center, Chaim Sheba Medical Center, Ramat Gan, Israel; <sup>10</sup>Department of Gastroenterology, Rabin Medical Center Belinson Campus, Petah-Tikva, Israel; <sup>11</sup>Spitalul Clinic Judetean de Urgenta Craiova, Craiova, Romania; <sup>12</sup>Division of Gastroenterology & Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan; <sup>13</sup>Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey; <sup>14</sup>Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy; <sup>15</sup>Shionogi Ltd., Holborn, London, United Kingdom; <sup>16</sup>Shionogi & Co., Ltd., Osaka, Japan; <sup>17</sup>Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.

  • Metabolism, Excretion, and Pharmacokinetics of [14C]-Cefiderocol (S-649266), a Siderophore Cephalosporin, in Healthy Subjects Following Intravenous Administration

    The Journal of Clinical Pharmacology.

    Miyazaki S<sup>1</sup>, Katsube T<sup>1</sup>, Shen H<sup>2</sup>, Tomek C<sup>3</sup>, Narukawa Y<sup>1</sup>.

    <sup>1</sup>Shionogi & Co., Ltd., Osaka, Japan; <sup>2</sup>QPS, LLC, Newark, Delaware, USA; <sup>3</sup>Celerion, Lincoln, Nebraska, USA.

  • Cefiderocol: A Siderophore Cephalosporin with Activity Against Carbapenem-Resistant and Multidrug-Resistant Gram-Negative Bacilli

    Drugs.

    Zhanel GG<sup>1,2</sup>, Golden AR<sup>3</sup>, Zelenitsky S<sup>4</sup>, Wiebe K<sup>4</sup>, Lawrence CK<sup>4</sup>, Adam HJ<sup>3,5</sup>, Idowu T<sup>6</sup>, Domalaon R<sup>6</sup>, Schweizer F<sup>3,6</sup>, Zhanel MA<sup>3</sup>, Lagacé-Wiens PRS<sup>3,5</sup>, Walkty AJ<sup>3,5</sup>, Noreddin A<sup>7</sup>, Lynch Iii JP<sup>8</sup>, Karlowsky JA<sup>3,5</sup>.

    <sup>1</sup>Department of Medical Microbiology and Infectious Diseases, Max Rady College of Medicine, Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada; <sup>2</sup>Clinical Microbiology, Health Sciences Centre, MS673-820 Sherbrook Street, Winnipeg, Manitoba, R3A 1R9, Canada; <sup>3</sup>Department of Medical Microbiology and Infectious Diseases, Max Rady College of Medicine, Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada; <sup>4</sup>College of Pharmacy, Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada; <sup>5</sup>Diagnostic Services, Shared Health, Winnipeg, MB, Canada; <sup>6</sup>Department of Chemistry, Faculty of Science, University of Manitoba, Winnipeg, MB, Canada; <sup>7</sup>College of Pharmacy, University of Sharjah, Sharjah, United Arab Emirates; <sup>8</sup>Division of Pulmonary, Critical Care, Allergy and Clinical Immunology, The David Geffen School of Medicine at UCLA, Los Angeles, California, USA.