Tavalisse

(Fostamatinib)

ApprovedSmall molecule

Tavalisse is a small molecule that works as a Tyrosine-Protein Kinase SYK Inhibitor; Tyrosine-Protein Kinase SYK Inhibitor.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Tavalisse is one of 301 small molecule programs targeting Diffuse Large B-Cell Lymphoma. It is currently in Approved.

Indications

Total Trials

Active Trials

300

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Diffuse Large B-Cell LymphomaApproved

Sickle Cell DisorderRecruiting

Ovarian CancerApproved

Lymphoid NeoplasmApproved

Anemia, Hemolytic, AutoimmuneApproved

IGA GlomerulonephritisApproved

Lung TransplantationApproved

Autoimmune Thrombocytopenic PurpuraActive, not recruiting

HemorrhageActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

Diffuse Large B-Cell LymphomaApproved

Approved

Sickle Cell DisorderPhase 1

Recruiting

Ovarian CancerApproved

Approved

Lymphoid NeoplasmApproved

Approved

Anemia, Hemolytic, AutoimmuneApproved

Approved

IGA GlomerulonephritisApproved

Approved

Lung TransplantationApproved

Approved

Autoimmune Thrombocytopenic PurpuraApproved

Active, not recruiting

HemorrhageApproved

Active, not recruiting

Immune ThrombocytopeniaPreclinical

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Tavalisse

RRigel Pharmaceuticals

Approved

1 2

Biltricide

Bayer

Preclinical

4 3

Dexilant

Takeda

Preclinical

2 4

Theo-Dur

Pfizer

Preclinical

1 5

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 6

Minipress

Pfizer

Preclinical

1 7

Niclocide

Bayer

Preclinical

1 8

Alfenta

Jazz Pharmaceuticals

Preclinical

1 9

Intuniv

PPromius Pharma, LLC

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Recruiting

Sickle Cell Disorder

NCT05904093

Q4 2027

Phase 2Not yet recruiting

Acute Respiratory Distress Syndrome

NCT06564207

Q3 2028

Phase 1Recruiting

Lung Transplantation

NCT06948097

Recruiting

Drug

NCT06757257

Q3 2029

Phase 1Recruiting

Refractory

NCT06233110

Clinical

Trials by Indication[1]

Rheumatoid Arthritis8 trials

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01197521·923 enrolled

A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT01640054·115 enrolled

Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01563978·266 enrolled

Show 5 more trials

Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT02092961·198 enrolled

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01197755·323 enrolled

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01197534·913 enrolled

Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT01569074·163 enrolled

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

Terminated· AstraZeneca logo

AstraZeneca·Phase 3·NCT01242514·1,917 enrolled

COVID-195 trials

Novel Experimental COVID-19 Therapies Affecting Host Response

Completed·SSean Collins·Phase 2/3·NCT04924660·1,060 enrolled

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

Terminated·NNEAT ID Foundation·Phase 2/3·NCT05593770·28 enrolled

Fostamatinib for Hospitalized Adults With COVID-19

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT04579393·59 enrolled

Show 2 more trials

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

Completed·RRigel Pharmaceuticals·Phase 3·NCT04629703·280 enrolled

Inflammatory Signal Inhibitors for COVID-19 (MATIS)

Completed·IImperial College London·Phase 1/2·NCT04581954·185 enrolled

Concentration5 trials

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01276262·22 enrolled

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01311622·15 enrolled

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01336218·15 enrolled

Show 2 more trials

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01309854·15 enrolled

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01355354·21 enrolled

ESS3 trials

Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01208155·24 enrolled

Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01387308·24 enrolled

Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01598571·37 enrolled

Function2 trials

A Study of Fostamatinib in Subjects With Impaired Kidney Function

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01245790·24 enrolled

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01222455·32 enrolled

18 more indications

Drug2 trials

A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01608542·24 enrolled

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

Recruiting·KKissei Pharmaceutical Co., Ltd.··NCT06757257·149 enrolled

Lymphoma2 trials

Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01499303·101 enrolled

Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma

Completed·RRigel Pharmaceuticals·Phase 1/2·NCT00446095·81 enrolled

Stem Cell Transplant1 trial

Evaluation of Fostamatinib in Patients With cGVHD After Allogeneic Stem Cell Transplant

Completed·—·Phase 1·NCT02611063·22 enrolled

Hematopoietic Stem Cell Transplant1 trial

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

Terminated·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT05502783·1 enrolled

Thrombocytopenia1 trial

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

Terminated·WWashington University School of Medicine·Phase 2·NCT04543279·3 enrolled

Nephropathy1 trial

Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy

Completed·RRigel Pharmaceuticals·Phase 2·NCT02112838·76 enrolled

Refractory1 trial

Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD

Recruiting·—·Phase 1·NCT06233110·30 enrolled

Completed·HHoldsworth House Medical Practice·Phase 2·NCT05040698·20 enrolled

Chronic Myelomonocytic Leukemia1 trial

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

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT05030675·11 enrolled

Acute Respiratory Distress Syndrome1 trial

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

Not yet recruiting·IInova Health Care Services·Phase 2·NCT06564207·40 enrolled

ITP1 trial

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

Completed·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla··NCT06071520·50 enrolled

Statin1 trial

Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01725230·42 enrolled

Treatment1 trial

Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection

Active, not recruiting·IImperial College London·Phase 1/2·NCT03991780·8 enrolled

Immune Thrombocytopenia1 trial

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

Terminated·RRigel Pharmaceuticals··NCT04904276·16 enrolled

Lung Transplantation1 trial

Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies.

Recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT06948097·30 enrolled

Sickle Cell Disorder1 trial

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

Recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT05904093·35 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 17, 2018

TAVALISSE

NDA NDA209299

Sources

References

[1]
ClinicalTrials.gov — 43 trial records for Fostamatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fostamatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fostamatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209299). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Tavalisse. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Rigel Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase SYK Inhibitor; Tyrosine-Protein Kinase SYK Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: RRigel Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Nov 6, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9266912Jan 19, 2026

RE48898Jan 19, 2026

8211889Jan 19, 2026

7538108Mar 28, 2026

7989448Jun 12, 2026

9 more patents

9283238Jun 17, 2026

8912170Jun 17, 2026

8163902Jun 17, 2026

8445485Jun 17, 2026

8652492Nov 6, 2028

8263122Nov 24, 2030

7449458Sep 4, 2031

8951504Jul 27, 2032

8771648Jul 27, 2032

Tavalisse

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q3 2028

Q3 2029

Trials by Indication[1]

Rheumatoid Arthritis8 trials

COVID-195 trials

Concentration5 trials

ESS3 trials

Function2 trials

Drug2 trials

Lymphoma2 trials

Stem Cell Transplant1 trial

Hematopoietic Stem Cell Transplant1 trial

Thrombocytopenia1 trial

Nephropathy1 trial

Refractory1 trial

Immune1 trial

Adult1 trial

Hidradenitis Suppurativa1 trial

Chronic Myelomonocytic Leukemia1 trial

Acute Respiratory Distress Syndrome1 trial

ITP1 trial

Statin1 trial

Treatment1 trial

Immune Thrombocytopenia1 trial

Lung Transplantation1 trial

Sickle Cell Disorder1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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