Imatinib clinical trials
Imatinib is named as an intervention in 35 current clinical trials in our China, France, Canada, Germany, Italy, Australia, Spain, Japan, USA, Taiwan, Mexico, Netherlands, Sweden, South Korea, Belgium, Switzerland, Czechia, Portugal, Norway, Austria, Singapore, Israel, Denmark, UK, Poland, Brazil, Ireland, India, Turkey and Egypt registers. 19 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Centre Leon Berard (3). The most-studied condition is Chronic Myeloid Leukemia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Imatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Imatinib was the US, on 10 May 2001. It is approved in 3 of the 3 regulators tracked here.
- 9 EU orphan designations, most recently for treatment of pulmonary arterial hypertension (21 Jun 2021, 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.
Imatinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Imatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 27 Apr 2040 (US 11957681).
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 Imatinib
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 Imatinib works
All drug targets →- Tyrosine-protein kinase ABL inhibitor InhibitorTarget: ABL1 ABL proto-oncogene 1, non-receptor tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- Platelet-derived growth factor receptor beta inhibitor InhibitorTarget: PDGFRB platelet derived growth factor receptor betaChEMBL only
- Stem cell growth factor receptor inhibitor InhibitorTarget: KIT KIT proto-oncogene, receptor tyrosine kinaseChEMBL only
- Bcr/Abl fusion protein inhibitor InhibitorTarget: Bcr/Abl fusion protein✓ In ChEMBL and the Guide to Pharmacology
- B-cell acute lymphoblastic leukemiaPhase 3
- COVID-19Phase 3
- T-cell acute lymphoblastic leukemiaPhase 3
- Acute lymphoblastic leukemiaPhase 3
- Acute respiratory distress syndromePhase 3
- Brain edemaPhase 3
- Chronic graft versus host diseasePhase 3
- Graft versus host diseasePhase 3
- Intestinal cancerPhase 3
- Ischemic strokePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL941, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5687, 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 Imatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 9 technology appraisals of Imatinib. 7 are current, and 6 of these recommend it for at least some patients. 2 older appraisals were replaced or withdrawn.
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 Imatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 15 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Glivec, Imatinib Accord (generic), Imatinib Teva (generic)EMA 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 Imatinib
- ATC code
- L01XE01
- ChEMBL
- CHEMBL941
- DrugBank
- DB00619
- PubChem CID
- 5291
- CAS number
- 152459-95-5
- FDA UNII
- BKJ8M8G5HI
- Wikidata
- Q177094
- Wikipedia
- Imatinib
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 Imatinib
35 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.
Imatinib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Imatinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy
2026-525913-30-00 · Immune System Diseases
|
Phase 3 | Ongoing | Sanofi-Aventis Recherche & Developpement | Belgium, Czechia, Hungary + 19 more |
Imatinib 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)
15 single-substance products containing Imatinib on the HPRA medicines list.
- Imatinib Krka d.d 100 mg film-coated tabletsKRKA, d.d., Novo mesto · PA1347/054/001 · Marketed
- Imatinib Krka d.d. 400 mg film-coated tabletsKRKA, d.d., Novo mesto · PA1347/054/002 · Marketed
- Imatinib Rowex 100 mg film-coated tabletsRowex Limited, · PA0711/248/001 · Marketed
- Imatinib Rowex 400 mg film-coated tabletsRowex Limited, · PA0711/248/002 · Marketed
- Glivec 100 mg film-coated tabletsNovartis Europharm Limited · EU/1/01/198/007-008
Supply shortages
No entry for Imatinib in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- ImkeldiFDA · 22 Nov 2024 · New Drug (NDA) · Shorla Oncology
Conditions studied with Imatinib
55 conditionsAll 55 conditions
| Condition (as registered) | Trials |
|---|---|
| Chronic Myeloid Leukemia | 2 |
| Gastrointestinal Stromal Tumors | 2 |
| B Acute Lymphoblastic Leukemia | 2 |
| Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | 2 |
| Respiratory Tract Diseases | 1 |
| Influenza (Pandemic) | 1 |
| Influenza | 1 |
| Community Acquired Pneumonia | 1 |
| Leukemia, Acute Lymphoblastic | 1 |
| Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive | 1 |
| Chronic Myelogenous Leukemia | 1 |
| Leukemia, Myelogenous, Chronic, BCR-ABL Positive | 1 |
| Gastrointestinal Stromal Neoplasms | 1 |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) | 1 |
| GIST - Gastrointestinal Stromal Tumor | 1 |
| GIST | 1 |
| GIST Metastatic Cancer | 1 |
| Gastro Intestinal Stromal Tumour | 1 |
| Graft-versus-host Disease | 1 |
| Chronic Myeloid Leukemia, Chronic Phase | 1 |
| Rare Tumor | 1 |
| Cancer | 1 |
| Progression-free Survival | 1 |
| Gastrointestinal Stromal Tumor | 1 |
| Neoadjuvant | 1 |
| Palmoplantar Pustulosis (PPP) | 1 |
| Solid Tumor Cancer | 1 |
| Hematological Neoplasms | 1 |
| CML, Chronic Phase | 1 |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | 1 |
| Unresectable Gastrointestinal Stromal Tumor (GIST) | 1 |
| Locally Advanced Gastrointestinal Stromal Tumor (GIST) | 1 |
| Metastatic Gastrointestinal Stromal Tumor | 1 |
| Metastatic Gastrointestinal Stromal Tumor (GIST) | 1 |
| C-KIT Mutation | 1 |
| Advanced Gastrointestinal Stromal Tumor (GIST) | 1 |
| Philadelphia Chromosome Positive CML | 1 |
| BCR-ABL Positive Chronic Myelogenous Leukemia | 1 |
| Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) | 1 |
| ALL, Adult | 1 |
| Philadelphia-Positive ALL | 1 |
| Breast Cancer | 1 |
| Triple Negative Breast Cancer | 1 |
| Rare Malignant Neoplasm | 1 |
| B Lymphoblastic Leukemia | 1 |
| Acute Lymphoblastic Leukemia | 1 |
| Mixed Phenotype Acute Leukemia | 1 |
| T Acute Lymphoblastic Leukemia | 1 |
| Chronic Myeloid Leukemia, BCR-ABL1 Positive | 1 |
| Minimal Residual Disease | 1 |
| Gastrointestinal Stromal Tumor (GIST) | 1 |
| Gastrointestinal Stromal Cancer | 1 |
| Gastrointestinal Stromal Neoplasm | 1 |
| Gastrointestinal Stromal Tumor, Malignant | 1 |
| Gastrointestinal Stromal Tumor of Rectum | 1 |
Sponsors
lead sponsor per trial+ 15 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Imatinib trials
How many clinical trials are testing Imatinib?
35 current trials in our China, France, Canada, Germany, Italy, Australia, Spain, Japan, USA, Taiwan, Mexico, Netherlands, Sweden, South Korea, Belgium, Switzerland, Czechia, Portugal, Norway, Austria, Singapore, Israel, Denmark, UK, Poland, Brazil, Ireland, India, Turkey and Egypt registers name Imatinib (also registered as STI571) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Imatinib trials recruiting patients?
Yes. 19 of the 35 trials are recruiting: 8 with sites in China, 5 with sites in France, 4 with sites in Canada, 4 with sites in Germany, 3 with sites in Italy, 3 with sites in Australia, 4 with sites in Spain, 3 with sites in Japan, 4 with sites in USA, 3 with sites in Taiwan, 2 with sites in Mexico, 3 with sites in Netherlands, 3 with sites in Sweden, 3 with sites in South Korea, 2 with sites in Belgium, 2 with sites in Switzerland, 2 with sites in Czechia, 3 with sites in Portugal, 3 with sites in Norway, 1 with sites in Austria, 2 with sites in Singapore, 1 with sites in Israel, 2 with sites in Denmark, 2 with sites in UK, 2 with sites in Poland, 2 with sites in Brazil, 2 with sites in Ireland, 1 with sites in India and 1 with sites in Turkey. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Imatinib clinical trials?
Centre Leon Berard (3), Novartis Pharmaceuticals (2), Jiangsu Hansoh Pharmaceutical Co., Ltd (2) and National Cancer Institute (NCI) (2), among 30 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Imatinib clinical trials in Ireland?
Yes. 2 trials 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 Imatinib licensed in Ireland?
Yes. The HPRA medicines list includes 15 single-substance products containing Imatinib, for example Imatinib Krka d.d 100 mg film-coated tablets (KRKA, d.d., Novo mesto). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Imatinib shortage?
Not in the lists we track: Imatinib 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 Imatinib 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 Imatinib 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 Imatinib (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.