Asciminib clinical trials
Asciminib is named as an intervention in 7 current clinical trials in our Germany, USA, South Korea, UK, India, France, Spain, Italy, Netherlands, Switzerland, Czechia, Canada, Singapore, China, Belgium, Sweden, Denmark, Austria, Norway, Portugal, Japan, Taiwan, Australia, Israel and Turkey registers. 2 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. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Asciminib is approved
All regulators →Of the three regulators tracked here, the first to approve Asciminib was the US, on 29 Oct 2021. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of chronic myeloid leukaemia (24 Mar 2020, 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.
Asciminib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Asciminib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 17 May 2040 (US 12252479).
- Latest patent on the drug substance itself: 14 May 2040 (US 11407735).
- Exclusivity ODE-499: Orphan drug exclusivity: treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia (ph+ CM…, until 29 Oct 2031.
- Exclusivity ODE-500: Orphan drug exclusivity: treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia (ph+…, until 29 Oct 2031.
- Exclusivity ODE-381: Orphan drug exclusivity: treatment of adult patients with philadelphia chromosome-positive chronic myeloid leukemia (ph+ CML) in chronic ph…, until 29 Oct 2028.
- Exclusivity ODE-382: Orphan drug exclusivity: treatment of adult patients with philadelphia chromosome-positive chronic myeloid leukemia (ph+ CML) in chronic ph…, until 29 Oct 2028.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 29 Oct 2028.
- Exclusivity M-318: Other exclusivity: modifications to labeling to include updated recommendations for cyp3a4 inducers and substrates of bcrp and updated data…, until 2 Oct 2028.
- 2 further exclusivities are listed.
- Scemblix for treatment of chronic myeloid leukaemia: until 26 Aug 2032. 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 Asciminib
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 Asciminib 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
- Acute lymphoblastic leukemiaPhase 2
- Acute promyelocytic leukemiaPhase 2
- Disease recurrencePhase 2
- Acute myeloid leukemiaPhase 1/2
- Breast cancerPhase 1/2
- LeukemiaPhase 1/2
- Lymphoid leukemiaPhase 1/2
- Childhood leukemiaPhase 1
- MedulloblastomaEarly phase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4208229, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8962, 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 Asciminib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Asciminib. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Asciminib for treating chronic myeloid leukaemia after 2 or more tyrosine kinase inhibitors NICE TA813 | Recommended | 3 Aug 2022 | 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 Asciminib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ScemblixEMA 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 Asciminib
- ChEMBL
- CHEMBL4208229
- DrugBank
- DB12597
- PubChem CID
- 72165228
- CAS number
- 1492952-76-7
- FDA UNII
- L1F3R18W77
- Wikidata
- Q27074535
- Wikipedia
- Asciminib
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 Asciminib
7 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.
Asciminib in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Asciminib. 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 |
|---|---|---|---|---|
|
Efficacy of asciminib in chronic phase CML patients with T315l mutations
2025-523491-23-00 · Neoplasms
|
Phase 2 | Authorised | Friedrich-Schiller-Universitaet Jena | Germany |
|
A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)
2025-522019-40-00 · CTIS ↗ · Neoplasms
|
Phase 1 | Authorised | Novartis Pharma AG | Italy, Spain, Germany + 4 more |
Asciminib 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)
3 single-substance products containing Asciminib on the HPRA medicines list.
- Scemblix 100 mg film-coated tabletsNovartis Europharm Limited · EU/1/22/1670/006-007
- Scemblix 20 mg film-coated tabletsNovartis Europharm Limited · EU/1/22/1670/001-002
- Scemblix 40 mg film-coated tabletsNovartis Europharm Limited · EU/1/22/1670/003-004
Supply shortages
No entry for Asciminib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Asciminib
8 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 3 |
| University of Jena | 1 |
| Thomas Ernst, PD Dr. med | 1 |
| Gruppo Italiano Malattie EMatologiche dell'Adulto | 1 |
| Korean Society of Hematology | 1 |
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 Asciminib trials
How many clinical trials are testing Asciminib?
7 current trials in our Germany, USA, South Korea, UK, India, France, Spain, Italy, Netherlands, Switzerland, Czechia, Canada, Singapore, China, Belgium, Sweden, Denmark, Austria, Norway, Portugal, Japan, Taiwan, Australia, Israel and Turkey registers name Asciminib as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Asciminib trials recruiting patients?
Yes. 2 of the 7 trials are recruiting: 1 with sites in South Korea and 1 with sites in Spain. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Asciminib clinical trials?
Novartis Pharmaceuticals (3), University of Jena (1), Thomas Ernst, PD Dr. med (1) and Gruppo Italiano Malattie EMatologiche dell'Adulto (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Asciminib licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Asciminib, for example Scemblix 100 mg film-coated tablets (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Asciminib shortage?
Not in the lists we track: Asciminib 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 Asciminib 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 Asciminib 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 Asciminib (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.