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Drug

Gemtuzumab ozogamicin

Approved medicine
ClassMyeloid cell surface antigen CD33 binding agentResearchOngoing clinical research

Also known as Mylotarg, hP67.6-Calicheamicin.

RxNorm1294580ChEMBLCHEMBL1201506ATCL01FX02UNII8GZG754X6M
15
Active clinical trials
Myeloid cell surface antigen CD33
Primary target
1
Regulatory events
Latest activity
beta

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

A Pilot Study of Liposomal Cytarabine and Daunorubicin (CPX-351) in Combination With Gemtuzumab Ozogamicin (GO) in Relapsed Refractory Patients With Acute Myeloid Leukemia (AML) and Post-Hypomethylating Agent (Post-HMA) Failure High-Risk Myelodysplastic Syndrome (HR-MDS)

Clinical trial2026-07-24Status changed to Completed · ClinicalTrials.gov

Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia

Clinical trial2026-07-23Results posted · ClinicalTrials.gov

Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia

Clinical trial2026-07-23Status changed to Completed · ClinicalTrials.gov

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Clinical trial2026-07-10Results expected Q2 2029 · ClinicalTrials.gov

Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy

Clinical trial2026-07-09Results expected Q4 2027 · ClinicalTrials.gov

A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia

Clinical trial2026-07-01Results posted · ClinicalTrials.gov

International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

Clinical trial2026-06-29Results expected Q4 2031 · ClinicalTrials.gov

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Clinical trial2026-06-18Results expected Q2 2029 · ClinicalTrials.gov

Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms

Clinical trial2026-05-22Results expected Q4 2027 · ClinicalTrials.gov

Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)

Clinical trial2026-05-20Results expected Q4 2027 · ClinicalTrials.gov

A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

Clinical trial2026-05-19Results expected Q1 2027 · ClinicalTrials.gov

Approval: Mylotarg (EMA)

Regulatory2018-04-19EMA

Profile

Identifiers & mechanism

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

Canonical name
Gemtuzumab ozogamicin
Aliases & brands
MylotarghP67.6-Calicheamicin
RxNorm CUI
1294580
ChEMBL ID
CHEMBL1201506
ATC codes
L01FX02
UNII
8GZG754X6M
Primary mechanism
Myeloid cell surface antigen CD33 binding agent
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Myeloid cell surface antigen CD33
CD33 · P20138
BINDING AGENTMyeloid cell surface antigen CD33 binding 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
2018-04-19
Latest approval
2018-04-19
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-04-19Approval
Approval: Mylotarg (EMA)
Indication: Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo… Show full indication

Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).

Evidence ↗

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

Clinical trials

83 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
83
registered trials across all phases
LATEST COMPLETION 2026
15
Active studies
12
Recruiting
18
Late-stage (III+)
53
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 83
Early Phase 11Phase 113Phase 1 / 210Phase 241Phase 2 / 34Phase 312Phase 42

Late-stage studies

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

A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN (MYLOTARG (TRADEMARKER)) AS A SINGLE-AGENT REGIMEN IN PATIENTS WITH RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA

CompletedPH IVPfizern=512021

A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)

CompletedPH IVWyeth is now a wholly owned subsidiary of Pfizern=302004

International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy

Active, not recruitingPH IIIUniversity of Birminghamn=7002032

A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

RecruitingPH IIIPedAL BCU, LLCn=1302031

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

RecruitingPH IIIKey trialChildren's Oncology Groupn=1,1862029

Recent completions

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

A Pilot Study of Liposomal Cytarabine and Daunorubicin (CPX-351) in Combination With Gemtuzumab Ozogamicin (GO) in Relapsed Refractory Patients With Acute Myeloid Leukemia (AML) and Post-Hypomethylating Agent (Post-HMA) Failure High-Risk Myelodysplastic Syndrome (HR-MDS)

CompletedPH IIM.D. Anderson Cancer Centern=502026

A Phase I Study to Evaluate the Safety and Tolerability of Gemtuzumab Ozogamicin and Midostaurin When Used in Combination With Standard Cytarabine and Daunorubicin Induction for Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia

CompletedPH IUma Boraten=212025

A Trial of Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults (ATACC AML)

CompletedPH IBaylor College of Medicinen=262025

Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia

CompletedPH I/IIBrown Universityn=112025

A Phase I Study of Liposomal Cytarabine and Daunorubicin (CPX-351) in Combination With Gemtuzumab Ozogamicin (GO) in Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia (AML)

CompletedPH IM.D. Anderson Cancer Centern=12025

Phase 1/1b Trial of Talazoparib and Gemtuzumab Ozogamicin in Adult Patients With Relapsed and/or Refractory Acute Myeloid Leukemia

CompletedPH IRoswell Park Cancer Instituten=242024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.