Tavalisse, Tavlesse(fostamatinib)
Tavalisse, Tavlesse (fostamatinib) is a small molecule pharmaceutical. Fostamatinib was first approved as Tavalisse on 2018-04-17. It is used to treat thrombocytopenia in the USA. It has been approved in Europe to treat thrombocytopenia.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
Fostamatinib, Tavalisse
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fostamatinib disodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TAVALISSE | Rigel Pharmaceuticals | N-209299 RX | 2018-04-17 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tavalisse | New Drug Application | 2025-11-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| thrombocytopenia | HP_0001873 | D013921 | D69.6 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FOSTAMATINIB DISODIUM, TAVALISSE, RIGEL PHARMS INC | |||
| 2025-04-17 | ODE-174 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fostamatinib Disodium, Tavalisse, Rigel Pharms Inc | |||
| 8771648 | 2032-07-27 | DP | |
| 8951504 | 2032-07-27 | U-2294 | |
| 7449458 | 2031-09-04 | DP | |
| 8263122 | 2030-11-24 | DP | |
| 8652492 | 2028-11-06 | DP | |
| 8163902 | 2026-06-17 | DP | U-2294 |
| 8445485 | 2026-06-17 | DP | |
| 8912170 | 2026-06-17 | U-2294 | |
| 9283238 | 2026-06-17 | U-2294 | |
| 7989448 | 2026-06-12 | DP | U-2294 |
| 7538108 | 2026-03-28 | DP | U-2294 |
| RE48898 | 2026-01-19 | DP | |
| 8211889 | 2026-01-19 | DP | |
| 9266912 | 2026-01-19 | U-2294 | |
HCPCS
No data
Clinical
Clinical Trials
67 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 1 | 3 | — | 2 | 6 |
| Thrombocytopenic purpura | D011696 | — | — | — | 1 | 3 | — | 1 | 5 |
| Purpura | D011693 | HP_0000979 | D69.2 | — | 1 | 3 | — | 1 | 5 |
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.10 | — | 1 | 2 | — | — | 3 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | 1 | — | — | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | 1 | 1 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 1 | 1 | — | — | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | 2 | — | — | 2 |
| Hemolysis | D006461 | — | — | — | — | 2 | — | — | 2 |
| Hemolytic anemia | D000743 | — | D55-D59 | — | — | 2 | — | — | 2 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 3 | — | — | — | 3 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 3 | — | — | — | 3 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 1 | — | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 2 | — | — | — | 2 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | 2 | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 1 | 2 | — | — | — | 2 |
| Primary myelofibrosis | D055728 | — | D47.4 | — | 1 | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | — | 1 | — | — | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | — | 1 | — | — | — | 1 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | — | — | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fostamatinib |
| INN | fostamatinib |
| Description | Fostamatinib, sold under the brand names Tavalisse and Tavlesse, is a tyrosine kinase inhibitor medication for the treatment of chronic immune thrombocytopenia (ITP). The drug is administered by mouth.
|
| Classification | Small molecule |
| Drug class | phosphoro-derivatives; tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc(Nc2ncc(F)c(Nc3ccc4c(n3)N(COP(=O)(O)O)C(=O)C(C)(C)O4)n2)cc(OC)c1OC |
Identifiers
| PDB | — |
| CAS-ID | 1025687-58-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103830 |
| ChEBI ID | — |
| PubChem CID | 11671467 |
| DrugBank | DB12010 |
| UNII ID | SQ8A3S5101 (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
Revenue by drug
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Tavalisse – Rigel Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,073 adverse events reported
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