Asset profile

Gilteritinib

Small molecule

Preview Research free. Sign in to unlock 3 full asset or company pages every day, no card needed.Sign in to unlock this page
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

Also in development:Non-Small Cell Lung Cancer · Phase 1/2

How the evidence outlook works ↗

Competitive landscape

125 competitors in this universe: 5 direct rivals (same mechanism and indication), 0 same-class, 120 same-indication.

Unlock with Research ↗
DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Gilteritinib: this drugApprovedSmall moleculeFLT3
QuizartinibApprovedSmall moleculeFLT3
Clifutinib BesylatePhase 3Small moleculeFLT3
XY0206Phase 3Small moleculeFLT3
Anti-CI135 CAR-TPhase 1Cell therapyFLT3
BMF-500Phase 1—FLT3
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
ASTX727ApprovedSmall moleculeDecitabine/cedazuridine fixed combination (DNMT + CDA inhibition)
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A
BAY2927088 (Hyrnuo)ApprovedSmall moleculeHER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR
BevacizumabApprovedMonoclonal antibodyVEGF-A, Vascular Endothelial Growth Factor Inhibitor
Bevacizumab-Awwb (MVASI)ApprovedMonoclonal antibodyVEGF-A

…and 110 more. Research shows the complete landscape.

Research

Unlock the full comparison

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

(32 total)

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

2026 (3)
December 2026 (3)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2026-12 · NCT06001788 · CT.gov ↗
What to watch
Unlock with Research ↗
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2026-12 · NCT05955261 · CT.gov ↗
What to watch
Unlock with Research ↗
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2026-12-31 · NCT05010772 · CT.gov ↗
What to watch
Unlock with Research ↗
2027 (8)
January 2027 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-01-31 · NCT06222580 · CT.gov ↗
What to watch
Unlock with Research ↗
February 2027 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-02-15 · NCT05024552 · CT.gov ↗
What to watch
Unlock with Research ↗
April 2027 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-04-21 · NCT05756777 · CT.gov ↗
What to watch
Unlock with Research ↗
May 2027 (2)
Phase 1Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8Recruiting
Est. primary completion 2027-05 · NCT06225427 · CT.gov ↗
What to watch
Unlock with Research ↗
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-05-31 · NCT07548710 · CT.gov ↗
What to watch
Unlock with Research ↗
June 2027 (2)
Phase 2Targeted Therapy, IDH1-Mutated Malignancies, MutationsRecruiting
Est. primary completion 2027-06-01 · NCT07032727 · CT.gov ↗
What to watch
Unlock with Research ↗
Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-06-30 · NCT04988555 · CT.gov ↗
What to watch
Unlock with Research ↗
October 2027 (1)
Phase 1/2Myeloid LeukemiaRecruiting
Est. primary completion 2027-10-01 · NCT06235801 · CT.gov ↗
What to watch
Unlock with Research ↗
2028 (12)
January 2028 (2)
Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-01-30 · NCT05010122 · CT.gov ↗
What to watch
Unlock with Research ↗
Early phase / not applicableAcute Myeloid LeukemiaRecruiting
Est. primary completion 2028-01-30 · NCT06265545 · CT.gov ↗
What to watch
Unlock with Research ↗
May 2028 (2)
Early phase / not applicableAcute Myeloid LeukemiaRecruiting
Est. primary completion 2028-05-10 · NCT07131059 · CT.gov ↗
What to watch
Unlock with Research ↗
Phase 3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-05-31 · NCT07463651 · CT.gov ↗
What to watch
Unlock with Research ↗
July 2028 (2)
Phase 2Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2028-07-10 · NCT05199051 · CT.gov ↗
What to watch
Unlock with Research ↗
Phase 1/2Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2028-07-31 · NCT05520567 · CT.gov ↗
What to watch
Unlock with Research ↗
August 2028 (2)
Phase 2Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2028-08 · NCT06667973 · CT.gov ↗
What to watch
Unlock with Research ↗
Early phase / not applicableHematological MalignanciesNot yet recruiting
Est. primary completion 2028-08 · NCT06992934 · CT.gov ↗
What to watch
Unlock with Research ↗
September 2028 (1)
Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-09-01 · NCT04140487 · CT.gov ↗
What to watch
Unlock with Research ↗
October 2028 (1)
Phase 2/3Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2028-10-01 · NCT07425808 · CT.gov ↗
What to watch
Unlock with Research ↗
December 2028 (2)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-12 · NCT06221683 · CT.gov ↗
What to watch
Unlock with Research ↗
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-12-31 · NCT07259707 · CT.gov ↗
What to watch
Unlock with Research ↗
2029 (7)
February 2029 (1)
Phase 3Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2029-02-01 · NCT07407140 · CT.gov ↗
What to watch
Unlock with Research ↗
April 2029 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-04 · NCT06696183 · CT.gov ↗
What to watch
Unlock with Research ↗
May 2029 (2)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-05-15 · NCT06317649 · CT.gov ↗
What to watch
Unlock with Research ↗
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-05-15 · NCT05564390 · CT.gov ↗
What to watch
Unlock with Research ↗
June 2029 (1)
Phase 3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-06-30 · NCT04293562 · CT.gov ↗
What to watch
Unlock with Research ↗
October 2029 (1)
Phase 2Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2029-10-01 · NCT07755202 · CT.gov ↗
What to watch
Unlock with Research ↗
December 2029 (1)
Phase 1Non-Small Cell Lung CancerRecruiting
Est. primary completion 2029-12-31 · NCT07140016 · CT.gov ↗
What to watch
Unlock with Research ↗
2030 (1)
May 2030 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2030-05-31 · NCT02115295 · CT.gov ↗
What to watch
Unlock with Research ↗
2032 (1)
December 2032 (1)
Phase 2/3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2032-12 · NCT03013998 · CT.gov ↗
What to watch
Unlock with Research ↗

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 (9)
Phase 2/3 (2)
Phase 2 (15)
Phase 1/2 (14)
Phase 1 (18)
Early phase / not applicable (3)