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Drug

Blinatumomab

Approved · EMA
ClassB-lymphocyte antigen CD19 cross-linking agentEmerging researchLate-stage development

Also known as Blincyto.

RxNorm1597258ChEMBLCHEMBL1742992ATCL01FX07UNII4FR53SIF3A
3
Research papers
88
Active clinical trials
4
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

The Regimen of Blinatumomab and Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating Precursor B Cell Acute Lymphoblastic Leukemia: A Phase II, Single Arm and Multicenter Study

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia

Clinical trial2026-07-28Results expected Q4 2030 · ClinicalTrials.gov

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Clinical trial2026-07-10Results expected Q4 2033 · ClinicalTrials.gov

Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

Clinical trial2026-07-10Results expected Q3 2027 · ClinicalTrials.gov

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Clinical trial2026-07-09Results expected Q4 2028 · ClinicalTrials.gov

A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy)

Clinical trial2026-07-08Results expected Q3 2027 · ClinicalTrials.gov

A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults

Clinical trial2026-07-08Results expected Q3 2028 · ClinicalTrials.gov

A Phase IB/II Study of Blinatumomab in Patients With Pre B-cell Acute Lymphoblastic Leukemia (ALL) and B-cell Non-Hodgkin Lymphoma (NHL) as Post-allogeneic Stem Cell Transplant (Allo-HSCT) Remission Maintenance

Clinical trial2026-07-06Results expected Q4 2026 · ClinicalTrials.gov

Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia.

Research2020-07-03Leukemia & lymphoma

The BiTE (bispecific T-cell engager) platform: Development and future potential of a targeted immuno-oncology therapy across tumor types.

Research2020-05-13Cancer

Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia.

Research2018-01-22Blood

Approval: Blincyto (EMA)

Regulatory2015-11-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Blinatumomab
Aliases & brands
Blincyto
RxNorm CUI
1597258
ChEMBL ID
CHEMBL1742992
ATC codes
L01FX07
UNII
4FR53SIF3A
Primary mechanism
B-lymphocyte antigen CD19 cross-linking agent
Regulatory jurisdictions
ema

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

B-lymphocyte antigen CD19
CD19 · P15391
CROSS-LINKING AGENTB-lymphocyte antigen CD19 cross-linking agent
T-cell surface glycoprotein CD3 epsilon chain
CD3E · P07766
CROSS-LINKING AGENTT cell surface glycoprotein CD3 cross-linking agent
T-cell surface glycoprotein CD3 gamma chain
CD3G · P09693
CROSS-LINKING AGENTT cell surface glycoprotein CD3 cross-linking agent
T-cell surface glycoprotein CD3 delta chain
CD3D · P04234
CROSS-LINKING AGENTT cell surface glycoprotein CD3 cross-linking agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-11-23
Latest approval
2015-11-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2015-11-23Approval
Approval: Blincyto (EMA)
Indication: Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (ALL). Patients with… Show full indication

Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B‑cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2). Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

139 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
139
registered trials across all phases
LATEST COMPLETION 2025
88
Active studies
65
Recruiting
36
Late-stage (III+)
30
Completed
21
Discontinued
PHASE DISTRIBUTIONn = 139
Early Phase 11Phase 121Phase 1 / 217Phase 264Phase 2 / 39Phase 315Phase 43Phase N / A9

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Refractory Autoimmune Encephalitis and Autoimmune Cerebellitis

Not yet recruitingPH IVBeijing Tiantan Hospitaln=122028

Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation

RecruitingPH IVSuping ZHANGn=602027

A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission

TerminatedPH IVAmgenn=102024

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

RecruitingPH II/IIIMerck Sharp & Dohme LLCn=3402033

A Phase 3, Open-label, Randomized, Controlled Trial of Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukaemia

Not yet recruitingPH IIIAmgenn=5602033

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1b Open-label Study to Investigate Safety, Tolerability and Pharmacokinetics of Intravenous Blinatumomab in Japanese Adult Subjects With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)

CompletedPH IAmgenn=62025

A Phase I Trial of the Combination of Lenalidomide and Blinatumomab in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma (NHL)

CompletedPH INational Cancer Institute (NCI)n=352025

Phase II Study of Blinatumomab in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

CompletedPH IIM.D. Anderson Cancer Centern=362025

A Phase 2 Study of Ibrutinib and Blinatumomab in Relapsed and Refractory B-Cell Acute Lymphoblastic Leukemia

CompletedPH IIUniversity of California, Davisn=192025

A Multicenter Phase II Study of Blinatumomab for Treatment of Adult Patients With Morphologic Relapsed/Refractory or Measurable Residual Disease (MRD) CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)

CompletedPH IIUniversity of Maryland, Baltimoren=22025

IIT2017-05-MERIN-BLINHMCT: Blinatumomab Plus HLA-Mismatched Cellular Therapy (HMCT) for Relapsed/Refractory CD19+ ALL

CompletedPH ICedars-Sinai Medical Centern=222024

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20182020
Major research themes4
Antibodies, Bispecific1Hematopoietic Stem Cell Transplantation1Precursor B-Cell Lymphoblastic Leukemia-Lymphoma1Precursor Cell Lymphoblastic Leukemia-Lymphoma1
Journals, researchers & institutions
Top journals
  • Blood1
  • Cancer1
  • Leukemia & lymphoma1
Leading researchers
  • Zugmaier G3
  • Bargou RC2
  • Bonifacio M2
  • Brüggemann M2
  • Dombret H2
  • Faul C2
  • Gökbuget N2
  • Graux C2
Leading institutions
free-text, unnormalised
  • University Hospital3
  • Comprehensive Cancer Center Mainfranken2
  • Universitätsklinikum Schleswig-Holstein2
  • Universitätsklinikum Würzburg2
  • Université Catholique de Louvain2
  • University Hôpital Saint-Louis2
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.