Back to discover
Drug

Fostamatinib disodium

Approved · FDA / EMA
Late-stage development

Also known as Tavalisse.

RxNorm2055929
1
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: FOSTAMATINIB DISODIUM (ANDA217329)

Regulatory2026-06-17FDA

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

Clinical trial2024-04-01Primary completion · ClinicalTrials.gov

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Clinical trial2023-12-11Results posted · ClinicalTrials.gov

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Clinical trial2023-05-25Results posted · ClinicalTrials.gov

Approval: Tavlesse (EMA)

Regulatory2020-01-09EMA

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Clinical trial2019-02-12Results posted · ClinicalTrials.gov

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Clinical trial2019-01-25Results posted · ClinicalTrials.gov

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic

Clinical trial2017-05-01Results posted · ClinicalTrials.gov

Phase II, Multicenter, Simon Two-Stage Study of Fostamatinib Disodium in Patients With Relapsed or Refractory T-Cell Lymphoma

Clinical trial2016-09-19Results posted · ClinicalTrials.gov

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

Clinical trial2016-09-16Results posted · ClinicalTrials.gov

A Phase 2, Multi-Centre, Open Label Extension Study of Fostamatinib in the Treatment of IgA Nephropathy for Patients Who Participated in Study C-935788-050

Clinical trial2015-10-23Withdrawn · ClinicalTrials.gov

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

Clinical trial2015-09-30Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fostamatinib disodium
Aliases & brands
Tavalisse
RxNorm CUI
2055929
Regulatory jurisdictions
fdaema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2020-01-09
Latest approval
2026-06-17
Authorities
FDA · EMA
Total events
2
fdaU.S. Food and Drug Administration· 1 event
2026-06-17Approval
Approval: FOSTAMATINIB DISODIUM (ANDA217329)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2020-01-09Approval
Approval: Tavlesse (EMA)

Indication: Tavlesse is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
12
registered trials across all phases
LATEST COMPLETION 2022
1
Active studies
1
Recruiting
5
Late-stage (III+)
8
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 12
Phase 27Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Enrolling by invitationPH IIIRigel Pharmaceuticalsn=902024

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

CompletedPH IIIRigel Pharmaceuticalsn=902022

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

CompletedPH IIIRigel Pharmaceuticalsn=1232020

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

CompletedPH IIIRigel Pharmaceuticalsn=742016

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

CompletedPH IIIRigel Pharmaceuticalsn=762016

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

CompletedPH IIIRigel Pharmaceuticalsn=902022

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

CompletedPH IIIRigel Pharmaceuticalsn=1232020

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

CompletedPH IIIRigel Pharmaceuticalsn=742016

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

CompletedPH IIIRigel Pharmaceuticalsn=762016

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

CompletedPH IINational Cancer Institute (NCI)n=372012

Phase II, Multicenter, Simon Two-Stage Study of Fostamatinib Disodium in Patients With Relapsed or Refractory T-Cell Lymphoma

CompletedPH IIRigel Pharmaceuticalsn=182010
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.