Shionogi

Shionogi

Japan - Osaka
Biotechnology2 H-1B visas (FY2023)
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Focus: Small Molecules, Injectors

Shionogi is a life sciences company focused on Small Molecules, Injectors.

Infectious Diseases
Open Jobs
0

Products & Portfolio (1)

7 discontinued products not shown

FETROJA
cefiderocol sulfate tosylate
Peak
INTRAVENOUS · POWDER
12.1 Mechanism of Action FETROJA is an antibacterial drug [see ] . 12.2 Pharmacodynamics The percent time of dosing interval that unbound plasma concentrations of cefiderocol exceed the minimum inhibitory concentration (MIC) against the infecting organism best correlates with antibacterial activity in neutropenic murine thigh and lung infection models with E. coli , K. pneumoniae , P. aeruginosa , A. baumannii , and S. maltophilia . Compared to a 1-hour infusion, a 3-hour infusion increased the percent time of dosing interval that unbound plasma concentrations of cefiderocol exceed the MIC. The in vivo animal pneumonia studies showed that the antibacterial activity of cefiderocol was greater at the human equivalent dosing regimen of 3-hour infusion compared to that of 1-hour infusion. Cardiac Electrophysiology At doses 1 and 2 times the maximum recommended dosage, FETROJA does not prolong the QT interval to any clinically relevant extent. 12.3 Pharmacokinetics Cefiderocol exposures (C max and daily AUC) in cUTI patients, HABP/VABP patients, and healthy volunteers are summarized in Table 6. Cefiderocol C max and AUC increased proportionally with dose. Table 6 Cefiderocol Exposures Mean (±SD) in Patients and Healthy Volunteers with CLcr 60 mL/min or Greater PK Parameters cUTI Patients After multiple (every 8 hours) FETROJA 2-gram doses infused over 3 hours or adjusted based on renal function. (N = 21) HABP/VABP Patients (N = 146) Healthy Volunteers After a single FETROJA 2-gram dose was infused over 3 hours. (N = 43) C max = maximum concentration. AUC 0-24 hr = area under the concentration time curve from 0 to 24 hours. C max (mg/L) 115 (±57) 111 (±56) 91.4 (±17.9) AUC 0-24 hr (mg∙hr/L) 1944 (±1097) 1773 (±990) 1175 (±203) Distribution The geometric mean (±SD) cefiderocol volume of distribution was 18.0 (±3.36) L. Plasma protein binding, primarily to albumin, of cefiderocol is 40% to 60%. Following a FETROJA 2-gram dose (or renal function equivalent dose) at steady state in patients with pneumonia requiring mechanical ventilation with a 3-hour infusion, the cefiderocol concentrations in epithelial lining fluid ranged from 3.1 to 20.7 mg/L and 7.2 to 15.9 mg/L at the end of infusion and at 2 hours after the end of infusion, respectively. Elimination Cefiderocol terminal elimination half-life is 2 to 3 hours. The geometric mean (±SD) cefiderocol clearance is estimated to be 5.18 (±0.89) L/hr. Metabolism Cefiderocol is minimally metabolized [less than 10% of a single radiolabeled cefiderocol dose of 1 gram (0.5 times the approved recommended dosage) infused over 1 hour]. Excretion Cefiderocol is primarily excreted by the kidneys. After a single radiolabeled cefiderocol 1-gram (0.5 times the approved recommended dosage) dose infused over 1 hour, 98.6% of the total radioactivity was excreted in urine (90.6% unchanged) and 2.8% in feces. Specific Populations No clinically significant differences in the pharmacokinetics of cefiderocol were observed based
older for the treatment of complicated urinary tract infections (cUTIs)including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coliKlebsiella pneumoniae+7 more
2019
0

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Interview Prep Quick Facts
Founded: 1878
Portfolio: 8 approved products
Top TAs: Infectious Diseases
H-1B (2023): 2 approvals
Portfolio Health
Pre-Launch3 (38%)
Peak1 (13%)
LOE Approaching4 (50%)
8 total products
Therapeutic Area Focus
Marketed
Pipeline

Visa Sponsorship

Sponsors Work Visas
H-1B Petitions (FY2023)
2
Approved
0
Denied
100%
Rate

Source: USCIS H-1B Employer Data Hub