MedPath

Fostamatinib

Generic Name
Fostamatinib
Brand Names
Tavalisse, Tavlesse
Drug Type
Small Molecule
Chemical Formula
C23H26FN6O9P
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

Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets

Phase 1
Completed
Conditions
Pharmacokinetics
Bioavailability
Interventions
First Posted Date
2010-09-23
Last Posted Date
2010-12-08
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT01208155
Locations
🇺🇸

Research Site, Overland Park, Kansas, United States

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2010-09-09
Last Posted Date
2014-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
923
Registration Number
NCT01197521
Locations
🇬🇧

Research Site, Wirral, United Kingdom

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: placebo
First Posted Date
2010-09-09
Last Posted Date
2014-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
323
Registration Number
NCT01197755
Locations
🇬🇧

Research Site, Wirral, United Kingdom

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2010-09-09
Last Posted Date
2014-04-17
Lead Sponsor
AstraZeneca
Target Recruit Count
913
Registration Number
NCT01197534
Locations
🇬🇧

Research Site, Swindon, United Kingdom

A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2010-07-22
Last Posted Date
2013-02-07
Lead Sponsor
AstraZeneca
Target Recruit Count
56
Registration Number
NCT01167868
Locations
🇺🇸

Research Site, Glendale, California, United States

A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and Renal Cell Carcinomas, and Pheochromocytoma and Thyroid Tumors (Multi-H...

Phase 2
Completed
Conditions
Carcinoma, Renal Cell
Head and Neck Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Pheochromocytoma
Interventions
First Posted Date
2009-06-18
Last Posted Date
2015-09-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
37
Registration Number
NCT00923481
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-12-09
Last Posted Date
2014-06-25
Lead Sponsor
AstraZeneca
Target Recruit Count
624
Registration Number
NCT00805467
Locations
🇷🇴

Research Site, Sibiu, Romania

Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma

Phase 2
Completed
Conditions
T Cell Lymphoma
Interventions
First Posted Date
2008-11-25
Last Posted Date
2016-09-19
Lead Sponsor
Rigel Pharmaceuticals
Target Recruit Count
18
Registration Number
NCT00798096
Locations
🇨🇦

Research Site, Toronto, Ontario, Canada

Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus

Phase 2
Withdrawn
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2008-09-16
Last Posted Date
2012-04-30
Lead Sponsor
Rigel Pharmaceuticals
Registration Number
NCT00752999

Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)

Phase 2
Completed
Conditions
Purpura, Thrombocytopenic, Idiopathic
Interventions
First Posted Date
2008-06-27
Last Posted Date
2016-06-03
Lead Sponsor
Rigel Pharmaceuticals
Target Recruit Count
18
Registration Number
NCT00706342
Locations
🇺🇸

Research Site, Cleveland, Ohio, United States

© Copyright 2025. All Rights Reserved by MedPath