FDA · United States
fostamatinib disodium — FDA regulatory status
fostamatinib disodium (TAVALISSE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- TAVALISSE
- Originator
- RIGEL PHARMACEUTICALS INC
- Mechanism
- Tyrosine-protein kinase SYK inhibitor
- Target
- Tyrosine-protein kinase SYK
- Structured fields
- 8
Sponsor / originator context: RIGEL PHARMACEUTICALS INC. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Tyrosine-protein kinase SYK inhibitor. Target: Tyrosine-protein kinase SYK. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 12 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Fostamatinib | Phase 3 | RIGEL PHARMACEUTICALS | NCT04629703 |
| Fostamatinib disodium | Phase 3 | RIGEL PHARMACEUTICALS | NCT02076399, NCT02076412 |
| Fostamatinib disodium | Phase 3 | RIGEL PHARMACEUTICALS | NCT03764618, NCT04138927 |
| Fostamatinib | Phase 2 | RIGEL PHARMACEUTICALS | NCT05040698 |
| Fostamatinib | Phase 2 | RIGEL PHARMACEUTICALS | NCT04543279 |
| Fostamatinib Disodium | Phase 2 | RIGEL PHARMACEUTICALS | NCT00798096 |
| Fostamatinib Disodium (R935788) | Phase 2 | RIGEL PHARMACEUTICALS | NCT00752999 |
| Fostamatinib Disodium / R935788 | Phase 2 | RIGEL PHARMACEUTICALS | NCT00706342 |
| Fostamatinib Disodium tablet 100 mg | Phase 2 | RIGEL PHARMACEUTICALS | NCT02433236 |
| Fostamatinib disodium (R935788) | Phase 2 | RIGEL PHARMACEUTICALS | NCT00665626, NCT00665925 |
| fostamatinib | Phase 2 | RIGEL PHARMACEUTICALS | NCT00446095 |
| Fostamatinib | Phase 1 | RIGEL PHARMACEUTICALS | NCT06233110 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12043620 | Benzazole compounds and methods for making and using the compounds | US |
| 11939317 | Amide compounds and method for making and using | US |
| 11827628 | Compositions and methods for inhibition of the JAK pathway | US |
| 11667611 | Compositions and methods for inhibition of the JAK pathway | US |
| 11530194 | Amide compounds and method for making and using | US |
| 11524955 | 2,4-diamino-pyrimidine compounds and method for making and using the compounds | US |
| 11370808 | Pyrazole compounds and methods for making and using the compounds | US |
| 11299486 | Benzazole compounds and methods for making and using the compounds | US |
| 11279686 | Nrf2 activating compounds and uses thereof | US |
| 11230554 | Methods of treating or preventing autoimmune diseases with 2,4-pyrimidinediamine compounds | US |
| 11220496 | Compounds and method for treating autoimmune diseases | US |
| 11198689 | Compositions and methods for inhibition of the JAK pathway | US |
Related hubs
FAQ
What is the FDA approval status of fostamatinib disodium?
fostamatinib disodium currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get fostamatinib disodium regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to fostamatinib disodium?
This spoke lists 12 published programs associated with fostamatinib disodium in our pipeline index.