Asset profile

Gemtuzumab Ozogamicin

Antibody–drug conjugate

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Approvedregulatory verdict

Evidence outlook

Approved: Acute Myeloid Leukemia

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Partial signal

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Competitive landscape

64 competitors in this universe: 4 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Gemtuzumab Ozogamicin: this drugApprovedAntibody–drug conjugateCD33
Lintuzumab-Ac225Phase 3RadiopharmaceuticalCD33
BL-M11D1Phase 2/3Antibody–drug conjugateCD33
Anti-CD33 CAR T-CellsPhase 1/2Biologic (subtype unspecified)CD33
PRGN-3006 T CellsPhase 1Cell therapyCD33
ASTX727ApprovedSmall moleculeDecitabine/cedazuridine fixed combination (DNMT + CDA inhibition)
EnasidenibApprovedSmall moleculeIDH2
GilteritinibApprovedSmall moleculeFLT3
MidostaurinApprovedSmall moleculeFLT3;KIT;PKC;PDGFR
OlutasidenibApprovedSmall moleculeMutant IDH1
QuizartinibApprovedSmall moleculeFLT3
RevumenibApprovedSmall moleculeMenin
Tretinoin (Vesanoid)ApprovedSmall moleculeRARA (retinoic acid receptor alpha); degrades the PML-RARA fusion oncoprotein in APL
VenetoclaxApprovedSmall moleculeBCL-2
VyxeosApprovedSmall moleculeDNA synthesis (cytarabine, antimetabolite) / Topoisomerase II
131I-ApamistamabPhase 3Monoclonal antibodyCD45

…and 49 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(15 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (2)
December 2026 (2)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2026-12 · NCT05955261 · CT.gov ↗
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Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2026-12-31 · NCT03737955 · CT.gov ↗
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2027 (7)
February 2027 (1)
Phase 3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-02 · NCT05183035 · CT.gov ↗
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April 2027 (2)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-04 · NCT05558124 · CT.gov ↗
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Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-04 · NCT04385290 · CT.gov ↗
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June 2027 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-06-30 · NCT04050280 · CT.gov ↗
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November 2027 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-11-25 · NCT06917911 · CT.gov ↗
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December 2027 (2)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-12-18 · NCT01409161 · CT.gov ↗
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Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-12-31 · NCT03589729 · CT.gov ↗
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2028 (3)
July 2028 (1)
Phase 2Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2028-07-10 · NCT05199051 · CT.gov ↗
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October 2028 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-10-11 · NCT00801489 · CT.gov ↗
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December 2028 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-12-31 · NCT06448013 · CT.gov ↗
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2029 (2)
January 2029 (1)
Phase 1Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2029-01 · NCT05662904 · CT.gov ↗
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June 2029 (1)
Phase 3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-06-30 · NCT04293562 · CT.gov ↗
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2031 (1)
December 2031 (1)
Phase 3Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2031-12 · NCT02724163 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (16)
Phase 2/3 (6)
Phase 2 (44)
Phase 1/2 (11)
Phase 1 (17)
Phase 4 (3)
Used as active comparator (3)
Appears in other studies (2)