Nilotinib clinical trials
Nilotinib is named as an intervention in 13 current clinical trials in our Germany, France, Netherlands, Czechia, UK, USA, China, Spain, Italy, Canada, South Korea, Singapore, Mexico, India, Denmark, Switzerland, Austria, Portugal, Japan, Taiwan, Israel, Turkey, Egypt, Belgium, Sweden, Norway, Australia, Poland and Brazil registers. 5 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Novartis Pharmaceuticals (3). The most-studied condition is Chronic Myeloid Leukemia.
Where Nilotinib is approved
All regulators →Of the three regulators tracked here, the first to approve Nilotinib was the US, on 29 Oct 2007. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of gastrointestinal stromal tumours (13 Apr 2007, withdrawn)
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.
Nilotinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Nilotinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 14 listed patents; the last listed expires 30 Apr 2041 (US 11559485).
- Latest patent on the drug substance itself: 7 Oct 2032 (US 9061029, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 23 Mar 2029.
- Exclusivity ODE-380: Orphan drug exclusivity: treatment of pediatric patients greater than or equal to 1 year of age with accelerated phase philadelphia chromos…, until 23 Sep 2028.
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 Nilotinib
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 Nilotinib 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
- Bcr/Abl fusion protein inhibitor InhibitorTarget: Bcr/Abl fusion protein✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- Acute lymphoblastic leukemiaPhase 3
- Gastrointestinal stromal tumorPhase 3
- Soft tissue sarcomaPhase 3
- Ewing sarcomaPhase 2
- Lewy body dementiaPhase 2
- Parkinson diseasePhase 2
- Acoustic neuromaPhase 2
- Acral lentiginous melanomaPhase 2
- Acute leukemia of ambiguous lineagePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL255863, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5697, 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 Nilotinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Nilotinib. 4 are current, and 4 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia NICE TA425 | Optimised Recommended Not recommended | 21 Dec 2016 | Current |
| Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia NICE TA426 | Recommended | 21 Dec 2016 | Current |
| Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia NICE TA251 | Recommended Not recommended | 25 Apr 2012 | Current |
| Dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia (CML) (part review of NICE technology appraisal guidance 70), and dasatinib and nilotinib for people with CML for whom treatment with imatinib has failed because of intolerance NICE TA241 | Recommended Not recommended | 13 Jan 2012 | 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 Nilotinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 11 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Tasigna, Nilotinib Accord (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 Nilotinib
- ATC code
- L01XE08
- ChEMBL
- CHEMBL255863
- DrugBank
- DB04868
- PubChem CID
- 644241
- CAS number
- 641571-10-0
- FDA UNII
- F41401512X
- Wikidata
- Q412327
- Wikipedia
- Nilotinib
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 Nilotinib
13 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.
Nilotinib 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)
11 single-substance products containing Nilotinib on the HPRA medicines list.
- Nilotinib Clonmel 150 mg hard capsulesClonmel Healthcare Ltd · PA0126/393/002 · Marketed
- Nilotinib Clonmel 200 mg hard capsulesClonmel Healthcare Ltd · PA0126/393/003 · Marketed
- Nilotinib Accord 150 mg Capsule, hardAccord Healthcare S.L.U. · EU/1/24/1845/005-014
- Nilotinib Accord 200 mg Capsule, hardAccord Healthcare S.L.U. · EU/1/24/1845/015-024
- Nilotinib Accord 50 mg Capsule, hardAccord Healthcare S.L.U. · EU/1/24/1845/001-004
Supply shortages
- Nilotinib Viatris 50 mg HartkapselnGermany (BfArM) · Other reason · 19 Dec 2025 to 15 Dec 2026
Conditions studied with Nilotinib
20 conditionsAll 20 conditions
| Condition (as registered) | Trials |
|---|---|
| Chronic Myeloid Leukemia | 4 |
| Chronic Myeloid Leukemia, Chronic Phase | 2 |
| Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | 2 |
| Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive | 1 |
| Philadelphia Chromosome-Positive Chronic Myeloid Leukemia | 1 |
| Chronic Myelogenous Leukemia | 1 |
| Leukemia, Myelogenous, Chronic, BCR-ABL Positive | 1 |
| Malignant Solid Neoplasms | 1 |
| CML, Chronic Phase | 1 |
| Chronic Myeloid Leukemia, BCR/ABL-Positive | 1 |
| Cancer | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Withdrawal;Drug | 1 |
| Minimal Residual Disease | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Anatomic Stage III Breast Cancer AJCC v8 | 1 |
| Anatomic Stage IV Breast Cancer AJCC v8 | 1 |
| Locally Advanced Malignant Solid Neoplasm | 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 Nilotinib trials
How many clinical trials are testing Nilotinib?
13 current trials in our Germany, France, Netherlands, Czechia, UK, USA, China, Spain, Italy, Canada, South Korea, Singapore, Mexico, India, Denmark, Switzerland, Austria, Portugal, Japan, Taiwan, Israel, Turkey, Egypt, Belgium, Sweden, Norway, Australia, Poland and Brazil registers name Nilotinib (also registered as AMN107) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Nilotinib trials recruiting patients?
Yes. 5 of the 13 trials are recruiting: 1 with sites in Germany, 2 with sites in France, 1 with sites in Netherlands, 1 with sites in Czechia, 1 with sites in UK, 1 with sites in USA, 1 with sites in China, 2 with sites in Spain, 1 with sites in Italy, 1 with sites in Canada, 1 with sites in South Korea, 1 with sites in Singapore, 2 with sites in Mexico, 1 with sites in Denmark, 1 with sites in Austria, 1 with sites in Portugal, 1 with sites in Japan, 1 with sites in Taiwan, 1 with sites in Israel, 1 with sites in Turkey, 1 with sites in Egypt, 1 with sites in Poland 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 Nilotinib clinical trials?
Novartis Pharmaceuticals (3), Jiangsu Hansoh Pharmaceutical Co., Ltd (1), University of Jena (1) and European LeukemiaNet (1), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Nilotinib licensed in Ireland?
Yes. The HPRA medicines list includes 11 single-substance products containing Nilotinib, for example Nilotinib Clonmel 150 mg hard capsules (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Nilotinib shortage?
The registers we track list 1 entry for Nilotinib: 1 German notice. Shortages are product- and country-specific; check with a pharmacist.
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 Nilotinib 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 Nilotinib 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 Nilotinib (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.