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Fostamatinib Disodium/ R935788

Phase 2

Purpura, Thrombocytopenic, Idiopathic | Small molecule | Hematology |Rigel Pharmaceuticals, Inc.|Last Updated: Jun 3, 2016

Target and mechanism

Molecular targetSYK
Target classInhibitor
ModalitySmall molecule

Also known as Fostamatinib disodium

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Fostamatinib Disodium/ R935788 · 1 trial · 1 indication

Phase 2 1
NCT00706342Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)Purpura, Thrombocytopenic, Idiopathic
COMPLETED18 Analytics
PHASE2COMPLETED
Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)
Purpura, Thrombocytopenic, IdiopathicUnlock trial analytics

Study Endpoints

Primary Endpoints

Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2
2 weeks
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6
6 Weeks
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12
12 Weeks
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24
24 Weeks
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12
12 Months
Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24
24 Months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
Fostamatinib Disodium / R935788DRUGR935788 tablets
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to admission to this study. * Patients may be male or female, between the ages of 18 75. Men, if sexually active, must agree to use at least one medically ...

Countries:United States
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Frequently asked questions about Fostamatinib Disodium/ R935788

What is Fostamatinib Disodium used for?

Fostamatinib Disodium is an investigational small molecule being studied for immune thrombocytopenic purpura, rheumatoid arthritis, T cell lymphoma, and warm antibody autoimmune hemolytic anemia. It is developed by Rigel Pharmaceuticals, Inc. (RIGL) and is currently in Phase 2 clinical development.

What does Fostamatinib Disodium target?

Fostamatinib Disodium is a kinase inhibitor, belonging to the -tinib class of drugs. It works by inhibiting spleen tyrosine kinase (Syk), which plays a role in immune signaling. This mechanism is being investigated for its potential effects in autoimmune and hematologic conditions.

Who makes Fostamatinib Disodium?

Fostamatinib Disodium is developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RIGL. The company is conducting clinical trials to evaluate the drug's safety and efficacy in several indications.

What phase is Fostamatinib Disodium in?

Fostamatinib Disodium is in Phase 2 clinical development. While some completed trials were Phase 3, the overall development program is currently at Phase 2 stage. It is investigational and not yet approved by regulatory authorities.

What clinical trials is Fostamatinib Disodium in?

Fostamatinib Disodium has been studied in several trials. NCT00798096 was a Phase 2 study in T cell lymphoma. NCT02076399 was a Phase 3 trial in immune thrombocytopenic purpura. NCT03764618 and NCT04138927 are Phase 3 studies in warm antibody autoimmune hemolytic anemia, with the latter currently enrolling by invitation.

Is Fostamatinib Disodium the same as R935788?

Yes, Fostamatinib Disodium is also known as R935788. In clinical trials, it has been referred to by this alternative name, such as in the study NCT02076399, which evaluated R935788 in the treatment of persistent or chronic immune thrombocytopenic purpura.