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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 the Bioavailability of 4 Different Fostamatinib Tablets

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2011-07-04
Last Posted Date
2011-10-28
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT01387308
Locations
🇺🇸

Research Site, Overland Park, Kansas, United States

Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Volunteers
Rheumatoid Arthritis
Interventions
First Posted Date
2011-05-18
Last Posted Date
2011-10-06
Lead Sponsor
AstraZeneca
Target Recruit Count
21
Registration Number
NCT01355354
Locations
🇬🇧

Research Site, London, United Kingdom

Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

Phase 1
Completed
Conditions
Healthy Volunteers
Rheumatoid Arthritis
Interventions
First Posted Date
2011-04-15
Last Posted Date
2011-07-22
Lead Sponsor
AstraZeneca
Target Recruit Count
15
Registration Number
NCT01336218
Locations
🇺🇸

Research Site, Overland Park, Kansas, United States

Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Healthy Subjects
Interventions
First Posted Date
2011-03-09
Last Posted Date
2013-01-31
Lead Sponsor
AstraZeneca
Target Recruit Count
15
Registration Number
NCT01311622
Locations
🇬🇧

Research Site, London, United Kingdom

Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Healthy Volunteers
Pharmacokinetics
Pioglitazone
Drug-drug Interaction
Amount of Pioglitazone in Blood
Interventions
First Posted Date
2011-03-07
Last Posted Date
2011-07-07
Lead Sponsor
AstraZeneca
Target Recruit Count
15
Registration Number
NCT01309854
Locations
🇺🇸

Research Site, Overland Park, Kansas, United States

Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects

Phase 1
Completed
Conditions
Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction
Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction
Interventions
Drug: Microgynon® 30 (Oral contraceptive)
Drug: Placebo
First Posted Date
2011-01-13
Last Posted Date
2012-02-20
Lead Sponsor
AstraZeneca
Target Recruit Count
22
Registration Number
NCT01276262
Locations
🇬🇧

Research Site, London, United Kingdom

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo of fostamatinib, fostamatinib, and placebo injections
First Posted Date
2010-12-22
Last Posted Date
2014-05-06
Lead Sponsor
AstraZeneca
Target Recruit Count
644
Registration Number
NCT01264770
Locations
🇬🇧

Research Site, Wolverhampton, United Kingdom

A Study of Fostamatinib in Subjects With Impaired Kidney Function

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Renal Impairment
Interventions
First Posted Date
2010-11-23
Last Posted Date
2011-06-16
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT01245790
Locations
🇺🇸

Research Site, Orlando, Florida, United States

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2010-11-17
Last Posted Date
2014-04-04
Lead Sponsor
AstraZeneca
Target Recruit Count
1917
Registration Number
NCT01242514
Locations
🇬🇧

Research Site, Wirral, United Kingdom

A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function

Phase 1
Completed
Conditions
Hepatic Impairment
Healthy Volunteers
Pharmacokinetics
Amount of R406 in Blood
Interventions
First Posted Date
2010-10-18
Last Posted Date
2011-07-06
Lead Sponsor
AstraZeneca
Target Recruit Count
32
Registration Number
NCT01222455
Locations
🇺🇸

Research Site, Orlando, Florida, United States

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