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

Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies

Phase 1

Not yet recruiting

Conditions: Lung Transplantation

Interventions: Drug: fostamatinib
Drug: Placebo

First Posted Date: 2025-04-29

Last Posted Date: 2025-05-21

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 30

Registration Number: NCT06948097

Locations: 🇺🇸
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
🇺🇸
Inova Health System Foundation, Falls Church, Virginia, United States

Special Drug Use-results Survey for Long-term Use (Fostamatinib)

Recruiting

Conditions: Chronic Idiopathic Thrombocytopenic Purpura

Interventions: Drug: fostamatinib

First Posted Date: 2025-01-03

Last Posted Date: 2025-01-03

Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Target Recruit Count: 149

Registration Number: NCT06757257

Locations: 🇯🇵
Research site, Tokyo And Japanese Other Cities, Japan

Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults

Phase 2

Not yet recruiting

Conditions: Acute Respiratory Distress Syndrome
ARDS

Interventions: Drug: Placebo
Drug: Fostamatinib

First Posted Date: 2024-08-21

Last Posted Date: 2025-03-14

Lead Sponsor: Inova Health Care Services

Target Recruit Count: 40

Registration Number: NCT06564207

Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD

Phase 1

Not yet recruiting

Conditions: Chronic Graft Versus Host Disease

Interventions: Drug: Fostamatinib
Drug: Ruxolitinib

First Posted Date: 2024-01-31

Last Posted Date: 2025-01-28

Lead Sponsor: Stefanie Sarantopoulos, MD, PhD.

Target Recruit Count: 30

Registration Number: NCT06233110

Locations: 🇺🇸
Duke, Durham, North Carolina, United States

Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study

Completed

Conditions: Primary Immune Thrombocytopenia

Interventions: Drug: Fostamatinib

First Posted Date: 2023-10-06

Last Posted Date: 2023-10-17

Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Target Recruit Count: 50

Registration Number: NCT06071520

Locations: 🇪🇸
Hospital Universitario de Jerez de la Frontera, Jerez De La Frontera, Cádiz, Spain
🇪🇸
Hospital de Puerto Real, Puerto Real, Cádiz, Spain
🇪🇸
Hospital Universitario Virgen Macarena, Sevilla, Spain

and more 11 locations

Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease

Phase 1

Recruiting

Conditions: Sickle Cell Disease
Hb-SS Disease
Hemoglobin S
Disease Sickle Cell Anemia
Sickle Cell Disorders
Hemoglobin Beta Thalassemia Disease

Interventions: Drug: Fostamatinib

First Posted Date: 2023-06-15

Last Posted Date: 2025-04-20

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 25

Registration Number: NCT05904093

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP

Completed

Conditions: ITP - Immune Thrombocytopenia
Chronic ITP
Refractory ITP

Interventions: Drug: Fostamatinib

First Posted Date: 2022-11-14

Last Posted Date: 2025-04-30

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 95

Registration Number: NCT05613296

Locations: 🇮🇹
Aou Policlinico Tor Vergata Uoc Trapianto Cellule Staminali, Roma, Italy
🇮🇹
Fondazione P.U. Agostino Gemelli Irccs - Area Ematologica, Roma, Italy
🇮🇹
Divisione di Ematologia "Città della Salute e della Scienza di Torino", Torino, Italy

and more 18 locations

International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response

Phase 2

Terminated

Conditions: COVID-19
Coronavirus Infection
SARS-CoV2 Infection

Interventions: Drug: Placebo
Drug: Fostamatinib

First Posted Date: 2022-10-25

Last Posted Date: 2025-05-02

Lead Sponsor: NEAT ID Foundation

Target Recruit Count: 28

Registration Number: NCT05593770

Locations: 🇿🇦
Global Clinical Trials (Pty) Ltd, Pretoria, South Africa
🇿🇦
Clinical HIV Research Unit - Helen Joseph Hospital (WITS CHRU), Johannesburg, South Africa
🇪🇸
Hospital Clinic Barcelona, Barcelona, Villarroel, Spain

and more 18 locations

Extension Study (Extended Access) of Syk-inhibition Using Fostamatinib to Treat Posttransplant Immune-mediated Cytopenias

Phase 2

Conditions: Immune Mediated Thrombocytopenia
Chronic GVHD
Immune Mediated Anemia

Interventions: Drug: fostamatinib

First Posted Date: 2022-08-22

Last Posted Date: 2025-05-21

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 20

Registration Number: NCT05509582

Locations: 🇺🇸
Atrium Health, Charlotte, North Carolina, United States
🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Using Fostamatinib to Treat Post-Hematopoietic Stem Cell Transplant Immune-mediated Cytopenias

Phase 2

Recruiting

Conditions: Immune Mediated Anemia
Immune Mediated Thrombocytopenia
Chronic GVHD

Interventions: Drug: fostamatinib

First Posted Date: 2022-08-16

Last Posted Date: 2025-05-16

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 20

Registration Number: NCT05502783

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy