Gilteritinib clinical trials
Gilteritinib is named as an intervention in 17 current clinical trials in our China, France, USA, Spain, Canada, Israel, Germany, Belgium, Switzerland, Italy, Mexico, Ireland, Netherlands, Sweden, Austria, Norway, Australia, UK, Japan, South Korea, Taiwan and Singapore registers. 13 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Institute of Hematology & Blood Diseases Hospital, China (3). The most-studied condition is Acute Myeloid Leukemia.
Where Gilteritinib is approved
All regulators →Of the three regulators tracked here, the first to approve Gilteritinib was the US, on 28 Nov 2018. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of acute myeloid leukaemia (17 Jan 2018, positive)
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.
Gilteritinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Gilteritinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 8 listed patents; the last listed expires 1 Jul 2036 (US 11938133).
- Latest patent on the drug substance itself: 28 Nov 2032 (US 8969336).
- Xospata for treatment of acute myeloid leukaemia: until 28 Oct 2029. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 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.
What health systems spend on Gilteritinib
All medicines →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.
How Gilteritinib works
All drug targets →- Tyrosine-protein kinase receptor FLT3 inhibitor InhibitorTarget: FLT3 fms related receptor tyrosine kinase 3✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase receptor UFO inhibitor InhibitorTarget: AXL AXL receptor tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- Myelodysplastic syndromePhase 3
- Chronic myeloid leukemiaPhase 2
- LeukemiaPhase 2
- Myeloid leukemiaPhase 2
- Myeloid neoplasmPhase 2
- Chronic myelomonocytic leukemiaPhase 1/2
- Myeloproliferative disorderPhase 1/2
- Non-small cell lung carcinomaPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3301622, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8708, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Gilteritinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Gilteritinib. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Gilteritinib for treating relapsed or refractory acute myeloid leukaemia NICE TA642 | Optimised | 12 Aug 2020 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Gilteritinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: XospataEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Gilteritinib
- ChEMBL
- CHEMBL3301622
- DrugBank
- DB12141
- PubChem CID
- 49803313
- CAS number
- 1254053-43-4
- FDA UNII
- 66D92MGC8M
- Wikidata
- Q27077802
- Wikipedia
- Gilteritinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Gilteritinib
17 trialsRegisters 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.
Gilteritinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Gilteritinib on the HPRA medicines list.
- Xospata 40 mg film-coated tabletsAstellas Pharma Europe B.V. · EU/1/19/1399/001
Supply shortages
No entry for Gilteritinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Gilteritinib
32 conditionsAll 32 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Myeloid Leukemia | 5 |
| AML | 3 |
| Acute Myeloid Leukemia (AML) | 2 |
| AML, Adult | 2 |
| Myelodysplastic Syndrome With Excess Blasts-2 | 1 |
| Leukemia, Myeloid, Acute | 1 |
| Leukemia, Lymphocytic, Acute | 1 |
| Multiple Myeloma | 1 |
| Myelodysplastic Syndromes | 1 |
| AML With Mutated NPM1 | 1 |
| Hematologic Malignancy | 1 |
| KMT2Ar | 1 |
| Acute Myeloid Leukemia, in Relapse | 1 |
| Acute Myeloid Leukemia Refractory | 1 |
| FLT3-mutated Acute Myeloid Leukemia | 1 |
| Non-small Cell Lung Cancer (NSCLC) | 1 |
| Anaplastic Lymphoma Kinase (ALK) Positive | 1 |
| FLT3 Gene Mutation | 1 |
| FLT3-ITD Mutation | 1 |
| Allogeneic Hematopoietic Cell Transplantation (HCT) | 1 |
| Maintenance Therapy | 1 |
| AML, Childhood | 1 |
| Refractory | 1 |
| Relapsed | 1 |
| AML - Acute Myeloid Leukemia | 1 |
| Refractory AML | 1 |
| Relapsed Adult AML | 1 |
| FLT3-TKD Mutation | 1 |
| Hematological Malignancies | 1 |
| Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm | 1 |
| Acute Myeloid Leukemia Post Cytotoxic Therapy | 1 |
| Acute Myeloid Leukemia, Myelodysplasia-Related | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Gilteritinib trials
How many clinical trials are testing Gilteritinib?
17 current trials in our China, France, USA, Spain, Canada, Israel, Germany, Belgium, Switzerland, Italy, Mexico, Ireland, Netherlands, Sweden, Austria, Norway, Australia, UK, Japan, South Korea, Taiwan and Singapore registers name Gilteritinib (also registered as ASP2215) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Gilteritinib trials recruiting patients?
Yes. 13 of the 17 trials are recruiting: 6 with sites in China, 3 with sites in France, 3 with sites in USA, 3 with sites in Spain, 3 with sites in Canada, 3 with sites in Israel, 1 with sites in Germany, 1 with sites in Belgium, 1 with sites in Switzerland, 2 with sites in Italy, 2 with sites in Mexico, 1 with sites in UK, 1 with sites in Japan, 1 with sites in South Korea, 1 with sites in Taiwan and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Gilteritinib clinical trials?
Institute of Hematology & Blood Diseases Hospital, China (3), Astellas Pharma Global Development, Inc (2), National Cancer Institute (NCI) (2) and Stichting Hemato-Oncologie voor Volwassenen Nederland (1), among 13 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Gilteritinib clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Gilteritinib licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Gilteritinib, for example Xospata 40 mg film-coated tablets (Astellas Pharma Europe B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Gilteritinib shortage?
Not in the lists we track: Gilteritinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Gilteritinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Gilteritinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Gilteritinib (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.