Blinatumomab clinical trials
Blinatumomab is named as an intervention in 52 current clinical trials in our China, Israel, Australia, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Mexico, Denmark, Austria, Sweden, Czechia, Portugal, Japan, USA, Norway, Switzerland, Turkey, South Korea, Ireland, UK, Brazil, Taiwan and Poland registers. 32 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 (8). The most-studied condition is Acute Lymphoblastic Leukemia. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Blinatumomab is approved
All regulators →Of the three regulators tracked here, the first to approve Blinatumomab was the US, on 3 Dec 2014. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of acute lymphoblastic leukaemia (24 Jul 2009, 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.
Blinatumomab patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Blinatumomab, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- BLINCYTO for treatment of acute lymphoblastic leukaemia: until 25 Nov 2027 (includes 24 months' paediatric extension). 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 Blinatumomab
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 Blinatumomab works
All drug targets →- T cell surface glycoprotein CD3 cross-linking agent Cross-linking agentTarget: T cell surface glycoprotein CD3✓ In ChEMBL and the Guide to Pharmacology
- B-lymphocyte antigen CD19 cross-linking agent Cross-linking agentTarget: CD19 CD19 molecule✓ In ChEMBL and the Guide to Pharmacology
- Mixed phenotype acute leukemiaPhase 3
- Precursor B-cell acute lymphoblastic leukemiaPhase 3
- B-cell adult acute lymphocytic leukemiaPhase 2/3
- B-cell childhood acute lymphoblastic leukemiaPhase 2/3
- T-cell acute lymphoblastic leukemiaPhase 2/3
- T-cell adult acute lymphocytic leukemiaPhase 2/3
- T-lymphoblastic lymphomaPhase 2/3
- Diffuse large B-cell lymphomaPhase 2/3
- Myasthenia gravisPhase 2/3
- Non-Hodgkin lymphomaPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1742992, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7384, 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 Blinatumomab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Blinatumomab. 4 are current, and 3 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Blinatumomab with chemotherapy for consolidation treatment of Philadelphia-chromosome-negative CD19-positive minimal residual disease-negative B-cell precursor acute lymphoblastic leukaemia NICE TA1049 | Optimised | 26 Mar 2025 | Current |
| Blinatumomab for previously treated Philadelphia-chromosome-positive acute lymphoblastic leukaemia (terminated appraisal) NICE TA686 | Terminated (no company submission) | 31 Mar 2021 | Current |
| Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity NICE TA589 | Optimised | 24 Jul 2019 | Current |
| Blinatumomab for previously treated Philadelphia-chromosome-negative acute lymphoblastic leukaemia NICE TA450 | Recommended | 28 Jun 2017 | 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 Blinatumomab
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: BlincytoEMA 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.
Trials by status
Trials by phase
Clinical trials of Blinatumomab
52 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.
Blinatumomab in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Blinatumomab. 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.
Blinatumomab 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 Blinatumomab on the HPRA medicines list.
- BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusionAmgen Europe B.V., · EU/1/15/1047/001
Supply shortages
No entry for Blinatumomab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Blinatumomab
64 conditionsAll 64 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Lymphoblastic Leukemia | 7 |
| B Acute Lymphoblastic Leukemia | 4 |
| ALL, Adult | 3 |
| Childhood Leukemia, Acute Lymphoblastic | 3 |
| Mixed Phenotype Acute Leukemia | 2 |
| Acute Lymphoblastic Leukemia ALL | 2 |
| B Cell Acute Lymphoblastic Leukemia (B-ALL) | 2 |
| Philadelphia-Positive ALL | 2 |
| B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | 2 |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia | 2 |
| B-cell Acute Lymphoblastic Leukemia | 2 |
| Recurrent B Acute Lymphoblastic Leukemia | 2 |
| Down Syndrome | 2 |
| B Lymphoblastic Lymphoma | 2 |
| B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | 2 |
| Leukemia, Acute Lymphoblastic | 1 |
| Systemic Lupus Erythematosus | 1 |
| Active Refractory Rheumatoid Arthritis | 1 |
| Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL) | 1 |
| B Cell Precursor Acute Lymphoblastic Leukemia | 1 |
| Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia | 1 |
| Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia | 1 |
| Leukemia, Myeloid, Chronic | 1 |
| Myeloid Leukemia | 1 |
| Chronic Myeloid Leukemia | 1 |
| Philadelphia Positive Acute Lymphoblastic Leukemia | 1 |
| Precursor B-Cell Lymphoblastic Leukemia | 1 |
| Philadelphia-Negative ALL | 1 |
| Autoimmune Encephalitis (AE) | 1 |
| Autoimmune Cerebellitis | 1 |
| Acute B-cell Lymphoblastic Leukemia | 1 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | 1 |
| B-Cell Acute Lymphoblastic Leukemia, Adult | 1 |
| ALL (Acute B-Lymphoblastic Leukemia) | 1 |
| Precursor B-Cell Acute Lymphoblastic Leukemia | 1 |
| B Precursor Acute Lymphoblastic Leukemia | 1 |
| Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia | 1 |
| Acute Lymphoblastic Leukemia, Adult | 1 |
| Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) | 1 |
| Ph+ ALL | 1 |
| Acute Lymphoblastic Leukemia, B-precursor | 1 |
| B-Cell Lymphoblastic Leukemia | 1 |
| Ph-Like | 1 |
| Systemic Lupus Erythematosus (SLE) | 1 |
| Children | 1 |
| Blinatumomab | 1 |
| Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) | 1 |
| Newly Diagnosed Mixed Phenotype Acute Leukemia | 1 |
| Primary Sjögren's Syndrome (pSS) | 1 |
| Acute Lymphoblastic Leukemia (ALL) | 1 |
| Stem Cell Transplant | 1 |
| Graft -Versus-host-disease | 1 |
| ALL, Recurrent, Adult | 1 |
| B-Cell Acute Lymphoblastic Leukaemia | 1 |
| Acute Lymphoblastic Leukemia, Pediatric | 1 |
| Acute Lymphoblastic Leukemia, Adult B-Cell | 1 |
| Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) | 1 |
| Central Nervous System Leukemia | 1 |
| Lymphoblastic Leukemia | 1 |
| Recurrent Acute Lymphoblastic Leukemia | 1 |
| Leukemia, Lymphoblastic, Acute, Philadelphia-Positive | 1 |
| Acute Lymphoblastic Lymphoma | 1 |
| Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis | 1 |
| Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL | 1 |
Sponsors
lead sponsor per trial+ 14 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 Blinatumomab trials
How many clinical trials are testing Blinatumomab?
52 current trials in our China, Israel, Australia, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Mexico, Denmark, Austria, Sweden, Czechia, Portugal, Japan, USA, Norway, Switzerland, Turkey, South Korea, Ireland, UK, Brazil, Taiwan and Poland registers name Blinatumomab (also registered as Cycle 1) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Blinatumomab trials recruiting patients?
Yes. 32 of the 52 trials are recruiting: 16 with sites in China, 8 with sites in Israel, 7 with sites in Australia, 6 with sites in Canada, 7 with sites in Germany, 7 with sites in France, 6 with sites in Italy, 5 with sites in Spain, 4 with sites in Netherlands, 4 with sites in Belgium, 2 with sites in Mexico, 5 with sites in Denmark, 4 with sites in Austria, 4 with sites in Sweden, 4 with sites in Czechia, 4 with sites in Portugal, 2 with sites in Japan, 2 with sites in USA, 4 with sites in Norway, 2 with sites in Switzerland, 1 with sites in Turkey, 1 with sites in South Korea, 2 with sites in Ireland, 1 with sites in UK, 1 with sites in Taiwan and 2 with sites in Poland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Blinatumomab clinical trials?
Institute of Hematology & Blood Diseases Hospital, China (8), National Cancer Institute (NCI) (7), Amgen (5) and First Affiliated Hospital of Zhejiang University (3), among 29 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Blinatumomab 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 Blinatumomab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Blinatumomab, for example BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion (Amgen Europe B.V.,). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Blinatumomab shortage?
Not in the lists we track: Blinatumomab 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 Blinatumomab 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 Blinatumomab 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 Blinatumomab (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.