Fostamatinib is named as an intervention in 2 current clinical trials in our UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Austria, Czechia, Norway, Australia and Japan registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Rigel Pharmaceuticals (1). The most-studied condition is Warm Antibody Autoimmune Hemolytic Anemia.
Of the three regulators tracked here, the first to approve Fostamatinib was the US, on 17 Apr 2018. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Protections still running for marketed products containing Fostamatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Special Drug Use-results Survey for Long-term Use (Fostamatinib)
NCT06757257 · ClinicalTrials.gov ↗ · Chronic Idiopathic Thrombocytopenic Purpura
|
Observational | Recruiting | Kissei Pharmaceutical Co., Ltd | Japan |
|
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
NCT04138927 · Warm Antibody Autoimmune Hemolytic Anemia
|
Phase 3 | By invitation | Rigel Pharmaceuticals | UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Austria, Czechia, Norway, Australia |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
2 single-substance products containing Fostamatinib on the HPRA medicines list.
No entry for Fostamatinib in the EMA, FDA or German BfArM shortage lists we track.
| Lead sponsor | Trials |
|---|---|
| Rigel Pharmaceuticals | 1 |
| Kissei Pharmaceutical Co., Ltd | 1 |
A trial with sites in more than one country appears in each of those registers.
2 current trials in our UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Austria, Czechia, Norway, Australia and Japan registers name Fostamatinib as a drug or biological intervention, as of the registry sync on 1 October 2026. Completed and withdrawn studies are not counted.
Yes. 1 of the 2 trials is recruiting: 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Rigel Pharmaceuticals (1) and Kissei Pharmaceutical Co., Ltd (1). The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 2 single-substance products containing Fostamatinib, for example Tavlesse 100 mg film-coated tablets (Rigel Pharmaceuticals B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Fostamatinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Fostamatinib works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Fostamatinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Fostamatinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 1 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.