Last update 26 May 2025

Gemtuzumab Ozogamicin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Anti-CD33-monoclonal-antibody-calicheamicin, Anti-CD33-monoclonal-antibody-p67-6-calicheamicin-conjugate, Gemtuzumab
+ [18]
Action
inhibitors
Mechanism
CD33 inhibitors(Myeloid cell surface antigen CD33 inhibitors), DNA inhibitors(DNA inhibitors)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (17 May 2000),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea)
Login to view timeline

Structure/Sequence

Boost your research with our ADC technology data.
Boost your research with our ADC technology data.

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Acute Myeloid Leukemia
Japan
25 Jul 2005
CD33-positive Acute Myeloid Leukemia
United States
17 May 2000
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Promyelocytic LeukemiaPhase 3-01 May 2002
acute leukemiaPhase 3
United States
01 May 2001
Acute Lymphoblastic LeukemiaPhase 3
United States
01 May 2001
Chronic phase chronic myeloid leukemiaPhase 3
United States
01 May 2001
Myelodysplastic SyndromesPhase 3
United States
01 May 2001
Refractory acute myeloid leukemiaPhase 3
United States
01 May 2001
Residual NeoplasmPhase 2
United States
30 Nov 2018
Myeloid TumorPhase 2
United States
14 Sep 2018
Recurrent Acute LeukemiaPhase 1
United States
23 Oct 2020
Relapsing acute myeloid leukemiaPhase 1
United States
23 Oct 2020
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
18
trem-cel + Mylotarg
nlnlbpyzzx(aiobkykzpk) = ujdmgwzpox udzdgmqbyd (alxqtltizq )
Positive
05 Sep 2024
Not Applicable
157
wqupibqczm(mrzppmhdyt) = No VOD-related deaths occurred bypevocnjy (irogotlpkt )
Positive
24 May 2024
Not Applicable
84
Gemtuzumab ozogamicin (GO)
zaudzccsxk(ntefystemy) = no VOD-related deaths were observed hquwtsytdu (qgrcwvqneu )
Positive
24 May 2024
Phase 2
Core binding factor acute myeloid leukemia
Consolidation | First line | Induction
RUNX1-RUNX1T1 | CBFB-MYH11 | FLT3 ...
179
btihndrkrp(crstfxjqaq) = avquabkxtu txguhtnomm (duhipiruzc )
Positive
14 May 2024
btihndrkrp(crstfxjqaq) = timqkhebba txguhtnomm (duhipiruzc )
Not Applicable
157
izkvljnqmc(xphnetbcnu) = Non-fatal VOD was reported in 7 (4%) patients ogmwzlscqi (suyqujxzan )
-
14 May 2024
Not Applicable
84
Gemtuzumab ozogamicin (GO) 1-3 mg/m2
tingxjbkoi(rknepcwlde) = Non-fatal VOD was reported in 6 (7%) patients, most cases were mild (n=5; 83%) gswkakydwx (pohwmurtsn )
-
14 May 2024
Gemtuzumab ozogamicin (GO) 4-6 mg/m2
Phase 3
265
Gemtuzumab ozogamicin + intensive chemotherapy
megtiiwfts(koziboahpe) = there was no increase in hemorrhages CTC ≥ 3° (9 and 16 cases in the GO and non-GO cohorts) ctecwdxbgr (semqgyzzjw )
Positive
14 May 2024
Intensive chemotherapy without Gemtuzumab ozogamicin
Phase 2
16
rsbczhalkb = bouzbartud rvbstqvpeg (atghqhaagw, ctoeoakjgb - jmrgegjfre)
-
18 Apr 2024
Phase 1/2
Acute Myeloid Leukemia
Maintenance
CD33-negative
6
cerdqdrtmc(gosfwvwliq) = dqfncxujvr wvzwfqhnol (krkpvgihed, 86 - 99)
Positive
01 Feb 2024
Not Applicable
20
alkkrpygcq(xplczercok) = One patient died from sepsis after hematopoietic stem cell transplant bfrcnohzhl (dzlcurlezr )
-
10 Dec 2023
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free