NDAORALTABLET
Approved
Apr 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 24m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAVALISSE (fostamatinib) is an oral small-molecule Syk inhibitor approved in 2018 for immune thrombocytopenia (ITP). It works by inhibiting spleen tyrosine kinase (Syk), a key enzyme in immune cell signaling, thereby reducing platelet destruction. This represents a novel mechanism for a chronic autoimmune bleeding disorder.
$40MPart D
Peak6.1 years to LOEProduct is at peak commercialization with modest Part D spending; team size likely stable with focus on market penetration rather than launch activities.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Started Aug 2026
40 enrolled
Acute Respiratory Distress SyndromeARDS
Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD
Started Oct 2025
30 enrolled
Chronic Graft Versus Host Disease
Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
Started Dec 2024
36 enrolled
Pancreatic Ductal Adenocarcinoma (PDAC)
Special Drug Use-results Survey for Long-term Use (Fostamatinib)
Started May 2023
149 enrolled
Chronic Idiopathic Thrombocytopenic Purpura
Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa
Started Oct 2021
20 enrolled
Hidradenitis Suppurativa
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.