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 of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa

Phase 2
Completed
Conditions
Hidradenitis Suppurativa
Interventions
First Posted Date
2021-09-10
Last Posted Date
2023-03-01
Lead Sponsor
Holdsworth House Medical Practice
Target Recruit Count
20
Registration Number
NCT05040698
Locations
🇦🇺

Holdsworth House Medical Practice, Sydney, New South Wales, Australia

Fostamatinib for the Treatment of Lower-risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia Who Have Failed Therapy with Hypomethylating Agents

Phase 1
Completed
Conditions
Refractory Myelodysplastic Syndrome
Refractory Chronic Myelomonocytic Leukemia
Interventions
First Posted Date
2021-09-01
Last Posted Date
2025-02-13
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
11
Registration Number
NCT05030675
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Novel Experimental COVID-19 Therapies Affecting Host Response

Phase 2
Completed
Conditions
COVID-19
SARS-CoV-2 Infection
Coronavirus Infection
Interventions
First Posted Date
2021-06-14
Last Posted Date
2025-01-22
Lead Sponsor
Sean Collins
Target Recruit Count
1060
Registration Number
NCT04924660
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Ponce de Leon Clinical Research Site, Atlanta, Georgia, United States

🇺🇸

Emory St. Joseph's Hospital, Atlanta, Georgia, United States

and more 48 locations

Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy

Terminated
Conditions
ITP
Immune Thrombocytopenia
Interventions
First Posted Date
2021-05-27
Last Posted Date
2024-03-15
Lead Sponsor
Rigel Pharmaceuticals
Target Recruit Count
16
Registration Number
NCT04904276
Locations
🇺🇸

Saint Agnes Hospital, Baltimore, Maryland, United States

🇺🇸

New York Medical College, Valhalla, New York, United States

🇺🇸

Boston Medical Center, Boston, Massachusetts, United States

and more 8 locations

Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

Phase 3
Completed
Conditions
SARS Pneumonia
Pneumonia
SARS (Severe Acute Respiratory Syndrome)
Pneumonia, Viral
SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Covid19
Interventions
Drug: Placebo
First Posted Date
2020-11-16
Last Posted Date
2023-08-18
Lead Sponsor
Rigel Pharmaceuticals
Target Recruit Count
280
Registration Number
NCT04629703
Locations
🇧🇷

Hospital Luxenburgo-Associação Mário Penna, Belo Horizonte, Minas Gerais, Brazil

🇧🇷

Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA, Porto Alegre, Rio Grande Do Sul, Brazil

🇺🇸

Alternative Research Associates, LLC, Miami, Florida, United States

and more 42 locations

Inflammatory Signal Inhibitors for COVID-19 (MATIS)

Phase 1
Conditions
Covid19
Coronavirus
Pneumonia
Interventions
First Posted Date
2020-10-09
Last Posted Date
2022-07-01
Lead Sponsor
Imperial College London
Target Recruit Count
456
Registration Number
NCT04581954
Locations
🇬🇧

Imperial College Healthcare NHS Trust, London, United Kingdom

Fostamatinib for Hospitalized Adults With COVID-19

Phase 2
Completed
Conditions
Coronavirus Disease 2019
Interventions
Drug: Placebo
First Posted Date
2020-10-08
Last Posted Date
2022-03-02
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
59
Registration Number
NCT04579393
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

🇺🇸

INOVA Health Systems, Falls Church, Virginia, United States

Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia

Phase 2
Terminated
Conditions
Myelofibrosis
Thrombocytopenia
Interventions
First Posted Date
2020-09-10
Last Posted Date
2023-12-15
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
3
Registration Number
NCT04543279
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Phase 3
Conditions
Warm Antibody Autoimmune Hemolytic Anemia
Interventions
First Posted Date
2019-10-25
Last Posted Date
2022-03-17
Lead Sponsor
Rigel Pharmaceuticals
Target Recruit Count
90
Registration Number
NCT04138927
Locations
🇺🇸

University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory, Los Angeles, California, United States

🇺🇸

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States

🇺🇸

Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

and more 34 locations

A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

Phase 3
Completed
Conditions
Idiopathic Thrombocytopenic Purpura
Interventions
Drug: Placebo
First Posted Date
2019-10-18
Last Posted Date
2023-12-21
Lead Sponsor
Kissei Pharmaceutical Co., Ltd.
Target Recruit Count
34
Registration Number
NCT04132050
Locations
🇯🇵

Research Site, Multiple Locations, Japan

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