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Tavalisse (FOSTAMATINIB)
Tavalisse works by blocking the activity of the FLT3 enzyme, which is involved in the production of platelets.
Tavalisse (Fostamatinib) is a small molecule modality developed by Rigel Pharms, targeting the receptor-type tyrosine-protein kinase FLT3. It was FDA-approved in 2018 for the treatment of chronic idiopathic thrombocytopenic purpura and immune thrombocytopenia. Tavalisse is a patented medication with no generic manufacturers available. Key safety considerations include potential liver enzyme elevations and bleeding risks. It is used to treat low platelet counts in patients with certain blood disorders.
At a glance
| Generic name | FOSTAMATINIB |
|---|---|
| Sponsor | Rigel Pharms |
| Target | Receptor-type tyrosine-protein kinase FLT3 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
Fostamatinib is tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK). The major metabolite of fostamatinib, R406, inhibits signal transduction of Fc-activating receptors and B-cell receptor. The fostamatinib metabolite R406 reduces antibody-mediated destruction of platelets.
Approved indications
- Thrombocytopenia in Chronic ITP
Common side effects
- Diarrhea
- Hypertension
- Nausea
- Dizziness
- ALT increased
- AST increased
- Respiratory infection
- Rash
- Abdominal pain
- Fatigue
- Chest pain
- Neutropenia
Key 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 (PHASE1)
- Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease (PHASE1)
- Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults (PHASE2)
- Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD (PHASE1)
- Using Fostamatinib to Treat Post-Hematopoietic Stem Cell Transplant Immune-mediated Cytopenias (PHASE2)
- Inflammatory Signal Inhibitors for COVID-19 (MATIS) (PHASE1,PHASE2)
- Extension Study (Extended Access) of Syk-inhibition Using Fostamatinib to Treat Posttransplant Immune-mediated Cytopenias (PHASE2)
- A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788 (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tavalisse CI brief — competitive landscape report
- Tavalisse updates RSS · CI watch RSS
- Rigel Pharms portfolio CI