Dasatinib clinical trials
Dasatinib is named as an intervention in 29 current clinical trials in our Canada, China, Mexico, Germany, Spain, Israel, France, Italy, Norway, Netherlands, Denmark, Austria, UK, USA, Czechia, Singapore, Australia, Belgium, Sweden, Portugal, Japan, South Korea, Taiwan, Poland, Egypt, Ireland, India, Switzerland, Turkey and Brazil registers. 10 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is National Cancer Institute (NCI) (5). The most-studied condition is Acute Lymphoblastic Leukemia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Dasatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Dasatinib was the US, on 28 Jun 2006. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of Diamond-Blackfan anaemia (22 Jun 2026, 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.
Dasatinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Dasatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 6 listed patents; the last listed expires 22 Jan 2041 (US 12544376).
- Exclusivity M-307: Other exclusivity: information added to the clinical pharmacology section to include results from a drug interaction study with gastric aci…, until 5 Dec 2026.
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 Dasatinib
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 Dasatinib works
All drug targets →- Bcr/Abl fusion protein inhibitor InhibitorTarget: Bcr/Abl fusion protein✓ In ChEMBL and the Guide to Pharmacology
- T-cell acute lymphoblastic leukemiaPhase 2/3
- Obesity disorderPhase 2/3
- Alzheimer diseasePhase 2
- B-cell chronic lymphocytic leukemiaPhase 2
- COVID-19Phase 2
- HIV infectious diseasePhase 2
- Acquired polycythemia veraPhase 2
- Acute myeloid leukemiaPhase 2
- AgingPhase 2
- Atypical chronic myeloid leukemia, BCR-ABL1 negativePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL5416410, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5678, 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 Dasatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Dasatinib. 5 are current, and 4 of these recommend it for at least some patients.
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 Dasatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 33 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Sprycel, Dasatinib Accord Healthcare (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 Dasatinib
- ChEMBL
- CHEMBL5416410
- PubChem CID
- 11540687
- CAS number
- 863127-77-9
- FDA UNII
- RBZ1571X5H
- Wikidata
- Q27139135
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 Dasatinib
29 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.
Dasatinib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Dasatinib. 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 |
|---|---|---|---|---|
|
Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Dasatinib To Reduce HIV-1 Reservoir, Chronic Inflammation, And Immune Senescence In People With HIV On Long-Term Antiretroviral Treatment.
2025-524363-20-01 · CTIS ↗ · Virus Diseases
|
Phase 2 | Authorised | Instituto De Salud Carlos III | Spain |
Dasatinib 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)
33 single-substance products containing Dasatinib on the HPRA medicines list.
- Dasatinib Clonmel 100 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/310/004 · Marketed
- Dasatinib Clonmel 20 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/310/001 · Marketed
- Dasatinib Clonmel 50 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/310/002 · Marketed
- Dasatinib Clonmel 70 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/310/003 · Marketed
- Dasatinib Teva 100 mg Film-coated TabletsTeva B.V. · PA1986/066/004 · Marketed
Supply shortages
No entry for Dasatinib in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- DasatinibFDA · 11 Sep 2026 · Generic (ANDA) · Msn
Conditions studied with Dasatinib
45 conditionsAll 45 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Lymphoblastic Leukemia | 4 |
| Chronic Myeloid Leukemia | 2 |
| B Acute Lymphoblastic Leukemia | 2 |
| B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | 2 |
| Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | 2 |
| Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent | 1 |
| Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent | 1 |
| Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory | 1 |
| Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive | 1 |
| Chronic Myelogenous Leukemia | 1 |
| Leukemia, Myelogenous, Chronic, BCR-ABL Positive | 1 |
| Hematologic Malignancies | 1 |
| Adult | 1 |
| Head and Neck Squamous Cell Carcinomas | 1 |
| Angioimmunoblastic T-cell Lymphoma (AITL) | 1 |
| Childhood Leukemia, Acute Lymphoblastic | 1 |
| T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma | 1 |
| Hematological Neoplasms | 1 |
| Chronic Myeloid Leukemia (CML) | 1 |
| Recent HIV-1 Infection | 1 |
| Alzheimer Disease, Early Onset | 1 |
| Mild Cognitive Impairment | 1 |
| Chronic Myeloid Leukemia, Chronic Phase | 1 |
| Withdrawal;Drug | 1 |
| Metastatic Colorectal Cancer | 1 |
| Advanced Lymphoma | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Bladder Carcinoma | 1 |
| Breast Carcinoma | 1 |
| Neuroblastoma | 1 |
| Acute Lymphoblastic Leukemia, Pediatric | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Multiple Myeloma | 1 |
| Advanced Solid Tumors | 1 |
| Glioblastoma | 1 |
| Recurrent Disease | 1 |
| Recurrent Glioblastoma | 1 |
| Chronic Myeloid Leukemia, BCR-ABL1 Positive | 1 |
| Recurrent Acute Lymphoblastic Leukemia | 1 |
| B Lymphoblastic Leukemia | 1 |
| Acute Lymphoblastic Lymphoma | 1 |
| B-cell Acute Lymphoblastic Leukemia | 1 |
| Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis | 1 |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL | 1 |
| Minimal Residual Disease | 1 |
Sponsors
lead sponsor per trial+ 9 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 Dasatinib trials
How many clinical trials are testing Dasatinib?
29 current trials in our Canada, China, Mexico, Germany, Spain, Israel, France, Italy, Norway, Netherlands, Denmark, Austria, UK, USA, Czechia, Singapore, Australia, Belgium, Sweden, Portugal, Japan, South Korea, Taiwan, Poland, Egypt, Ireland, India, Switzerland, Turkey and Brazil registers name Dasatinib (also registered as BMS 354825) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Dasatinib trials recruiting patients?
Yes. 10 of the 29 trials are recruiting: 4 with sites in Canada, 3 with sites in China, 2 with sites in Mexico, 2 with sites in Germany, 2 with sites in Spain, 2 with sites in Israel, 2 with sites in France, 2 with sites in Italy, 2 with sites in Norway, 1 with sites in Netherlands, 2 with sites in Denmark, 2 with sites in Austria, 1 with sites in UK, 1 with sites in USA, 1 with sites in Czechia, 2 with sites in Singapore, 1 with sites in Australia, 1 with sites in Belgium, 1 with sites in Sweden, 1 with sites in Portugal, 1 with sites in Japan, 1 with sites in South Korea, 1 with sites in Taiwan, 1 with sites in Poland, 1 with sites in Ireland, 1 with sites in Turkey and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Dasatinib clinical trials?
National Cancer Institute (NCI) (5), Novartis Pharmaceuticals (2), Princess Maxima Center for Pediatric Oncology (1) and Kumquat Biosciences Inc (1), among 24 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Dasatinib 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 Dasatinib licensed in Ireland?
Yes. The HPRA medicines list includes 33 single-substance products containing Dasatinib, for example Dasatinib Clonmel 100 mg film-coated tablets (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Dasatinib shortage?
Not in the lists we track: Dasatinib 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 Dasatinib 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 Dasatinib 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 Dasatinib (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.