DeepMed Research

Fostamatinib

Generic Name: Fostamatinib

Brand Names: Tavalisse, Tavlesse

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₆FN_₆O_₉P

CAS Number: 901119-35-5

Unique Ingredient Identifier: SQ8A3S5101

Background: Fostamatinib has been investigated for the treatment and basic science of Rheumatoid Arthritis and Immune Thrombocytopenic Purpura (ITP). It was approved on April 17, 2018, under the trade name Tavalisse for use in ITP . Fostamatinib has also been granted orphan drug status by the FDA .

Recently, fostamatinib has been identified as a potential therapeutic for controlling acute respiratory distress syndrome (ARDS) in patients with severe COVID-19 through its ability to modulate the SYK kinase.

Indication: 用于治疗对既往治疗反应不足的慢性免疫性血小板减少症（ITP）成年患者的血小板减少症。

Associated Conditions: Chronic immune thrombocytopenia

Clinical Trials

A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Phase 3

Completed

Conditions: Immune Thrombocytopenic Purpura

Interventions: Drug: Fostamatinib disodium
Drug: Placebo

First Posted Date: 2014-03-03

Last Posted Date: 2019-02-12

Lead Sponsor: Rigel Pharmaceuticals

Target Recruit Count: 76

Registration Number: NCT02076399

Locations: 🇺🇸
University of Southern California, Los Angeles, California, United States
🇬🇧
Colchester General Hospital, Colchester, Essex, United Kingdom
🇮🇹
OspedaleCivile-ClinicaEmatologica/PUGD, Udine, Italy

and more 49 locations

A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Phase 3

Completed

Conditions: Immune Thrombocytopenic Purpura

Interventions: Drug: Fostamatinib Disodium
Drug: Placebo

First Posted Date: 2014-03-03

Last Posted Date: 2019-01-25

Lead Sponsor: Rigel Pharmaceuticals

Target Recruit Count: 74

Registration Number: NCT02076412

Locations: 🇳🇴
Haukeland University Hospital, Bergen, Norway
🇦🇹
Medizinische Universitaet Wien / AKH Wien, Wien, AU, Austria
🇷🇴
Spitalul Clinic Coltea, Hematologie, Bucuresti, Romania

and more 32 locations

Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib

Phase 1

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Fostamatinib
Drug: Simvastatin
Drug: Rosuvastatin

First Posted Date: 2012-11-12

Last Posted Date: 2013-02-04

Lead Sponsor: AstraZeneca

Target Recruit Count: 42

Registration Number: NCT01725230

Locations: 🇺🇸
Research Site, Overland Park, Kansas, United States

Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)
Drug: Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
Drug: Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)
Drug: Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed
Drug: Ranitidine

First Posted Date: 2012-09-10

Last Posted Date: 2012-12-28

Lead Sponsor: AstraZeneca

Target Recruit Count: 28

Registration Number: NCT01682408

A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

Phase 2

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Fostamatinib

First Posted Date: 2012-07-13

Last Posted Date: 2014-03-28

Lead Sponsor: AstraZeneca

Target Recruit Count: 115

Registration Number: NCT01640054

Locations: 🇻🇳
Research Site, Ho Chi Minh, Vietnam

A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects

Phase 1

Completed

Conditions: Healthy Japanese Volunteers

Interventions: Drug: Fostamatinib 100mg
Drug: Fostamatinib 200mg

First Posted Date: 2012-05-31

Last Posted Date: 2012-12-19

Lead Sponsor: AstraZeneca

Target Recruit Count: 24

Registration Number: NCT01608542

Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Fostamatinib

First Posted Date: 2012-05-15

Last Posted Date: 2012-08-22

Lead Sponsor: AstraZeneca

Target Recruit Count: 37

Registration Number: NCT01598571

Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis

Phase 2

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Fostamatinib
Drug: Placebo

First Posted Date: 2012-04-02

Last Posted Date: 2014-04-07

Lead Sponsor: AstraZeneca

Target Recruit Count: 163

Registration Number: NCT01569074

Locations: 🇻🇳
Research Site, Ho Chi Minh, Vietnam

Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: fostamatinib
Drug: placebo

First Posted Date: 2012-03-27

Last Posted Date: 2014-05-08

Lead Sponsor: AstraZeneca

Target Recruit Count: 266

Registration Number: NCT01563978

Locations: 🇺🇦
Research Site, Zaporozhye, Ukraine

Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer

Phase 2

Completed

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: Fostamatinib

First Posted Date: 2011-12-26

Last Posted Date: 2014-08-22

Lead Sponsor: AstraZeneca

Target Recruit Count: 101

Registration Number: NCT01499303

Locations: 🇬🇧
Research Site, Southampton, United Kingdom

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