Astellas

Astellas

China - Shenyang
Biotechnology1 H-1B visas (FY2023)
WebsiteLinkedInCareers Page

Focus: Small Molecules, ADC, Cell Therapy, Gene Therapy, Viral, Antibodies

Astellas is a life sciences company focused on Small Molecules, ADC, Cell Therapy, Gene Therapy, Viral, Antibodies.

Gene TherapyCell Therapy
Employees
5000+
Open Jobs
0

Products & Portfolio (15)

30 discontinued products not shown

AMBISOME
amphotericin b
LOE Approaching
INJECTION · INJECTABLE, LIPOSOMAL
CLINICAL PHARMACOLOGY Pharmacokinetics The assay used to measure amphotericin B in the serum after administration of Am B isome does not distinguish amphotericin B that is complexed with the phospholipids of Am B isome from amphotericin B that is uncomplexed. The pharmacokinetic profile of amphotericin B after administration of Am B isome is based upon total serum concentrations of amphotericin B. The pharmacokinetic profile of amphotericin B was determined in febrile neutropenic cancer and bone marrow transplant patients who received 1-2 hour infusions of 1 to 5 mg/kg/day Am B isome for 3 to 20 days. The pharmacokinetics of amphotericin B after administration of Am B isome is nonlinear such that there is a greater than proportional increase in serum concentrations with an increase in dose from 1 to 5 mg/kg/day. The pharmacokinetic parameters of total amphotericin B (mean ± SD) after the first dose and at steady state are shown in the table below. Pharmacokinetic Parameters of AmBisome Dose 1 mg/kg/day 2.5 mg/kg/day 5 mg/kg/day Day 1 n = 8 Last n = 7 1 n = 7 Last n = 7 1 n = 12 Last n = 9 Parameters C max (mcg/mL) 7.3 ± 3.8 12.2 ± 4.9 17.2 ± 7.1 31.4 ± 17.8 57.6 ± 21 83 ± 35.2 AUC 0-24 (mcg•hr/mL) 27 ± 14 60 ± 20 65 ± 33 197 ± 183 269 ± 96 555 ± 311 t ½ (hr) 10.7 ± 6.4 7 ± 2.1 8.1 ± 2.3 6.3 ± 2 6.4 ± 2.1 6.8 ± 2.1 V ss (L/kg) 0.44 ± 0.27 0.14 ± 0.05 0.40 ± 0.37 0.16 ± 0.09 0.16 ± 0.10 0.10 ± 0.07 Cl (mL/hr/kg) 39 ± 22 17 ± 6 51 ± 44 22 ± 15 21 ± 14 11 ± 6 Distribution Based on total amphotericin B concentrations measured within a dosing interval (24 hours) after administration of Am B isome, the mean half-life was 7-10 hours. However, based on total amphotericin B concentration measured up to 49 days after dosing of Am B isome, the mean half-life was 100-153 hours. The long terminal elimination half-life is probably a slow redistribution from tissues. Steady state concentrations were generally achieved within 4 days of dosing. Although variable, mean trough concentrations of amphotericin B remained relatively constant with repeated administration of the same dose over the range of 1 to 5 mg/kg/day, indicating no significant drug accumulation in the serum. Metabolism The metabolic pathways of amphotericin B after administration of Am B isome are not known. Excretion The mean clearance at steady state was independent of dose. The excretion of amphotericin B after administration of Am B isome has not been studied. Pharmacokinetics in Special Populations Renal Impairment The effect of renal impairment on the disposition of amphotericin B after administration of Am B isome has not been studied. However, Am B isome has been successfully administered to patients with pre-existing renal impairment (see ). Hepatic Impairment The effect of hepatic impairment on the disposition of amphotericin B after administration of Am B isome is not known. Pediatric and Elderly Patients The pharmacokinetics of amphotericin B after administration of Am B isome in pediatr
Cryptococcal Meningitis in HIV-infected patients (see )unacceptable toxicity precludes the use of amphotericin B deoxycholatevisceral leishmaniasis
1997
30
ASTAGRAF XL
tacrolimus extended-release capsules
Peak
ORAL · CAPSULE, EXTENDED RELEASE
protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (a ubiquitous mammalian intracellular enzyme) is then formed and the phosphatase activity of calcineurin is inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT), and nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB). Tacrolimus inhibits the expression and/or production of several cytokines that include interleukin (IL)-1 beta, IL‑2, IL-3, IL-4, IL-5, IL-6, IL-8, IL-10, gamma interferon, tumor necrosis factor-alpha, and granulocyte macrophage colony-stimulating factor. Tacrolimus also inhibits IL-2 receptor expression and nitric oxide release, induces apoptosis and production of transforming growth factor-beta that can lead to immunosuppressive activity. The net result is the inhibition of T-lymphocyte activation and proliferation as well as T-helper-cell-dependent B-cell response (i.e., immunosuppression).
organ rejection in kidney transplant patients in combination with other immunosuppressants in adult
2013
30
CRESEMBA
isavuconazonium sulfate
LOE Approaching
ORAL · CAPSULE
isavuconazole, an azole antifungal [see ()] .
invasive aspergillosis()] CRESEMBA capsules : adultsolder+4 more
2015
15
CRESEMBA
isavuconazonium sulfate
LOE Approaching
INTRAVENOUS · POWDER
isavuconazole, an azole antifungal [see ()] .
invasive aspergillosis()] CRESEMBA capsules : adultsolder+4 more
2015
25
IZERVAY
avacincaptad pegol sodium
Growth
INTRAVITREAL · SOLUTION
aptamer, a PEGylated oligonucleotide that binds to and inhibits complement protein C5. By inhibiting C5, avacincaptad pegol may prevent its cleavage to C5a and C5b thus decreasing membrane attack complex (MAC) formation.
geographic atrophy (GA) secondary to age-related macular degeneration (AMD) ()
2023
0
LEXISCAN
regadenoson
LOE Approaching
INTRAVENOUS · SOLUTION
Adenosine Receptor Agonists
2008
25
PADCEV
enfortumab vedotin
Peak
ADCINJECTION · INJECTABLE
vedotin-ejfv is an ADC. The antibody is a human IgG1 kappa directed against Nectin-4, an adhesion protein located on the surface of cells. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker. Nonclinical data suggest that the anticancer activity of enfortumab vedotin-ejfv is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalization of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage. Release of MMAE disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptosis. The combination of enfortumab vedotin-ejfv with a PD-1 blocking antibody resulted in up-regulation of immune function and increased anti-tumor activity in syngeneic mouse tumor models expressing Nectin-4.
metastatic urothelial cancer (mUC)mUC who: • have previously received a programmed death receptor-1 (PD-1)programmed death-ligand 1 (PD-L1) inhibitor+3 more
2019
30
PROGRAF
tacrolimus
Peak
ORAL · FOR SUSPENSION
protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (a ubiquitous mammalian intracellular enzyme) is then formed, after which the phosphatase activity of calcineurin is inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT), and nuclear factor kappa-light-chain enhancer of activated B-cells (NF-κB). Tacrolimus inhibits the expression and/or production of several cytokines that include interleukin (IL)-1 beta, IL-2, IL-3, IL-4, IL-5, IL-6, IL-8, IL-10, gamma interferon, tumor necrosis factor-alpha, and granulocyte macrophage colony-stimulating factor. Tacrolimus also inhibits IL-2 receptor expression and nitric oxide release, induces apoptosis and production of transforming growth factor beta that can lead to immunosuppressive activity. The net result is the inhibition of T-lymphocyte activation and proliferation, as well as T-helper-cell-dependent B-cell response (i.e., immunosuppression).
organ rejection in adultkidneyheart+3 more
2018
45
PROGRAF
tacrolimus
LOE Approaching
INJECTION · INJECTABLE
protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (a ubiquitous mammalian intracellular enzyme) is then formed, after which the phosphatase activity of calcineurin is inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT), and nuclear factor kappa-light-chain enhancer of activated B-cells (NF-κB). Tacrolimus inhibits the expression and/or production of several cytokines that include interleukin (IL)-1 beta, IL-2, IL-3, IL-4, IL-5, IL-6, IL-8, IL-10, gamma interferon, tumor necrosis factor-alpha, and granulocyte macrophage colony-stimulating factor. Tacrolimus also inhibits IL-2 receptor expression and nitric oxide release, induces apoptosis and production of transforming growth factor beta that can lead to immunosuppressive activity. The net result is the inhibition of T-lymphocyte activation and proliferation, as well as T-helper-cell-dependent B-cell response (i.e., immunosuppression).
organ rejection in adultkidneyheart+3 more
1994
45
PROGRAF
tacrolimus
LOE Approaching
ORAL · CAPSULE
protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (a ubiquitous mammalian intracellular enzyme) is then formed, after which the phosphatase activity of calcineurin is inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT), and nuclear factor kappa-light-chain enhancer of activated B-cells (NF-κB). Tacrolimus inhibits the expression and/or production of several cytokines that include interleukin (IL)-1 beta, IL-2, IL-3, IL-4, IL-5, IL-6, IL-8, IL-10, gamma interferon, tumor necrosis factor-alpha, and granulocyte macrophage colony-stimulating factor. Tacrolimus also inhibits IL-2 receptor expression and nitric oxide release, induces apoptosis and production of transforming growth factor beta that can lead to immunosuppressive activity. The net result is the inhibition of T-lymphocyte activation and proliferation, as well as T-helper-cell-dependent B-cell response (i.e., immunosuppression).
organ rejection in adultkidneyheart+3 more
1994
45
VEOZAH
fezolinetant
Growth
ORAL · TABLET
Neurokinin 3 Receptor Antagonists
2023
0
VYLOY
zolbetuximab
Growth
mAbINJECTION · INJECTABLE
Claudin 18.2-directed Antibody Interactions
2024
30
View all 15 products

Pipeline & Clinical Trials

N/A
Clinical Trials (5)
NCT01777217VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate
Phase 4
NCT00573508Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
Phase 4
NCT00821184Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
Phase 3

+2 more

Reproducibility Study of Overactive Bladder Symptom Score [OABSS]
Overactive Bladder
N/A
Clinical Trials (1)
NCT01122550Reproducibility Study of Overactive Bladder Symptom Score [OABSS]
N/A
N/A
Clinical Trials (5)
NCT00510913A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
Phase 4
NCT03644485Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients
Phase 4
NCT00905515Optima: Optimizing Prograf Therapy in Maintenance Allografts II
Phase 4

+2 more

Enzalutamide, 160mg, 40 mg soft capsules, once daily
Metastatic Castration Resistant Prostate Cancer
N/A
Clinical Trials (1)
NCT02471469Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
N/A
Urinary Kidney Injury Molecule-1 (KIM-1) Excretion As Biomarker for Injury in Kidney Transplant Reci
Kidney Transplant Dysfunction
N/A
Clinical Trials (1)
NCT00805571Urinary Kidney Injury Molecule-1 (KIM-1) Excretion As Biomarker for Injury in Kidney Transplant Recipients
N/A
Immune Status in Solid Organ Transplantation
Organ Transplants
N/A
Clinical Trials (1)
NCT01070901Immune Status in Solid Organ Transplantation
N/A
Topical Local Anaesthesia and Cooling During Capsaicin 8% Patch Application
Pain
N/A
Clinical Trials (1)
NCT01523951Topical Local Anaesthesia and Cooling During Capsaicin 8% Patch Application
N/A
Half-dose of the Tc99-m sestamibi
Myocardial Infarction
N/A
Clinical Trials (1)
NCT01499654Half-Dose Radiopharmaceutical in Wide Beam Reconstruction
N/A
N/A
Clinical Trials (1)
NCT02160054Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)
N/A
N/A
Clinical Trials (5)
NCT06505746A Study of Real-world Treatment of Adults With Urothelial Cancer in South Korea and Saudi Arabia
N/A
NCT06150820A Study About Antibody Levels and Biomarkers in the Blood in People With Late-onset Pompe Disease
N/A
NCT03619980A Non-Interventional Study to Evaluate Time to Event and Healthcare Resource Utilisation for Prostate Cancer Participants Throughout the Disease Trajectories Until Progression or Death
N/A

+2 more

N/A
Clinical Trials (1)
NCT03409081Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
N/A
A Natural History Study of Angelman Syndrome
Angelman Syndrome
N/A
Clinical Trials (1)
NCT07417137A Natural History Study of Angelman Syndrome
N/A
N/A
Clinical Trials (1)
NCT02386072A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
N/A
N/A
Clinical Trials (5)
NCT00871260Stress Testing and Cardiac Magnetic Resonance
Phase 4
NCT02597543Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction
Phase 4
NCT01446094Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease
Phase 4

+2 more

N/A
Clinical Trials (1)
NCT06452212Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients
N/A
N/A
Clinical Trials (2)
NCT02805348Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease
N/A
NCT01903213Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis
N/A
A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Bio
Prostate Cancer
N/A
Clinical Trials (1)
NCT02066961A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer
N/A
Caspofungin or Micafungin as Empiric Antifungal Therapy for Persistent Fever and Neutropenia
Febrile Neutropenia
N/A
Clinical Trials (1)
NCT00723073Caspofungin or Micafungin as Empiric Antifungal Therapy for Persistent Fever and Neutropenia
N/A
N/A
Clinical Trials (2)
NCT02110394Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia
N/A
NCT02072967Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
N/A
Urinary Cytokines in Patients With Overactive Bladder (OAB)
Overactive Bladder
N/A
Clinical Trials (1)
NCT00868621Urinary Cytokines in Patients With Overactive Bladder (OAB)
N/A
A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication
Overactive Bladder (OAB)
N/A
Clinical Trials (1)
NCT01317810A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication
N/A
Tacrolimus
Validation
N/A
Clinical Trials (1)
NCT02377609To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks
N/A
N/A
Clinical Trials (1)
NCT03602508Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
N/A
N/A
Clinical Trials (1)
NCT01265537A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
N/A
FLT3 Clonal Evolution in Patients With Acute Myeloid Leukemia
Acute Myeloid Leukemia
N/A
Clinical Trials (1)
NCT06463639FLT3 Clonal Evolution in Patients With Acute Myeloid Leukemia
N/A
Delphi questionnaire
Overactive Bladder Syndrome
N/A
Clinical Trials (1)
NCT04300400Treatment of the Overactive Bladder Syndrome: A Delphi Study
N/A
N/A
Clinical Trials (1)
NCT01889576The Effect of Magnesium on Early Post-transplantation Glucose Metabolism
N/A
Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study
Prostate Cancer
N/A
Clinical Trials (1)
NCT05381311Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study
N/A
N/A
Clinical Trials (1)
NCT01876121Celecoxib Japan Observational Study for the Patients With Acute Pain
N/A
N/A
Clinical Trials (1)
NCT01842035Heart Rate Response to Regadenoson and Sudden Cardiac Death
N/A
Data Collection on Depo-Eligard exposure
Prostate Cancer
N/A
Clinical Trials (1)
NCT00811876Retrospective, Non-interventional Study of Depo-Eligard®.
N/A
Amevive exposure
Chronic Plaque Psoriasis
N/A
Clinical Trials (2)
NCT00795353Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis
N/A
NCT00342862AMEVIVE® Pregnancy Registry
N/A
N/A
Clinical Trials (1)
NCT01606982Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
N/A
Aspirin
Chest Pain
N/A
Clinical Trials (2)
NCT02786979Efficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients
Phase 4
NCT00743197Women With Chest Pain and Normal Coronary Arteries Study
N/A
N/A
FFR Measurement with IV Adenoscan® then with Regadenoson
Coronary Artery Disease
N/A
Clinical Trials (1)
NCT01482169Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)
N/A
Alefacept exposure
Psoriasis
N/A
Clinical Trials (1)
NCT00454701Assessment and Tracking of Long-term Alefacept Safety
N/A
N/A
Clinical Trials (1)
NCT01737294Observation of the Use of QUTENZA™ in Standard Clinical Practice
N/A
Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines
Solid Organ Transplantation
N/A
Clinical Trials (1)
NCT07291258Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation
N/A
Myocardial Perfusion imaging with 10 minute waiting period
Coronary Artery Disease
N/A
Clinical Trials (1)
NCT02136706Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol
N/A
Cardiac SPECT imaging Rest and Stress
Coronary Artery Disease
N/A
Clinical Trials (1)
NCT00205166Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
N/A
No Intervention
Menopause
N/A
Clinical Trials (1)
NCT05083884A Survey About Hot Flashes in Women Going Through the Menopause
N/A
Telmisartan 80mg
Hypertension
N/A
N/A
Clinical Trials (1)
NCT01870908Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients
N/A
Novel hormonal therapy
Prostatic Neoplasms
N/A
Clinical Trials (1)
NCT06072196A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
N/A
N/A
Clinical Trials (2)
NCT01919047Drug Use-Results Survey of Betanis Tablets in Japan
N/A
NCT01901120Long-Term Specified Drug Use-results Survey of Betanis Tablets
N/A
Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation
Heart Transplantation
N/A
N/A
Clinical Trials (1)
NCT02678598A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections
N/A
This is not an intervention study
Overactive Bladder
N/A
Clinical Trials (1)
NCT04534946A Pilot Study Evaluating the Usability of the Oabi Mobile Application
N/A
N/A
Clinical Trials (1)
NCT07086651A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)
N/A

Open Jobs (0)

No open positions listed yet. Check their careers page directly.

Interview Prep Quick Facts
Portfolio: 45 approved products, 161 clinical trials
Top TAs: Oncology, Nephrology, Gastroenterology
H-1B (2023): 1 approval
Portfolio Health
Growth3 (7%)
Peak7 (16%)
LOE Approaching18 (40%)
Post-LOE17 (38%)
45 total products
Therapeutic Area Focus
Oncology
5 marketed243 pipeline
Nephrology
4 marketed136 pipeline
Gastroenterology
3 marketed59 pipeline
Immunology
56 pipeline
Cardiovascular
3 marketed48 pipeline
Neurology
29 pipeline
Hematology
24 pipeline
Marketed
Pipeline

Visa Sponsorship

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

Source: USCIS H-1B Employer Data Hub