Asset profile

Gilteritinib

Small molecule

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 ↗

Upcoming events

(22 total)

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

2026 (2)
September 2026 (1)
Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2026-09-01 · NCT06561880 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2026 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2026-10 · NCT06022003 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2027 (3)
May 2027 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-05-31 · NCT07548710 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

June 2027 (1)
Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-06-30 · NCT04988555 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2027 (1)
Phase 1/2Myeloid LeukemiaActive not recruiting
Est. primary completion 2027-10-01 · NCT06235801 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2028 (10)
January 2028 (1)
Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-01-30 · NCT05010122 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

May 2028 (1)
Phase 3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-05-31 · NCT07463651 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

July 2028 (2)
Phase 2Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2028-07-10 · NCT05199051 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 1/2Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2028-07-31 · NCT05520567 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

August 2028 (1)
Phase 2Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2028-08 · NCT06667973 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

September 2028 (1)
Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-09-01 · NCT04140487 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2028 (1)
Phase 2/3Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2028-10-01 · NCT07425808 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

December 2028 (3)
Phase 1/2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-12 · NCT03013998 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-12 · NCT06221683 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-12-31 · NCT07259707 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2029 (6)
February 2029 (1)
Phase 3Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2029-02-01 · NCT07407140 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

April 2029 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-04 · NCT06696183 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

May 2029 (2)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-05-15 · NCT05564390 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-05-15 · NCT06317649 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

June 2029 (1)
Phase 3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-06-30 · NCT04293562 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

October 2029 (1)
Phase 2Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2029-10-01 · NCT07755202 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

2030 (1)
May 2030 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2030-05-31 · NCT02115295 · CT.gov ↗
What to watch

Research analysis

Source-grounded endpoint goals, benchmarks, comparator context, and caveats for this readout are included with Research.

See the full readout calendar ↗

All registered studies

Research

Unlock the complete ClinicalTrials.gov registry

Research includes every linked study, indication filters, phase grouping and featured-trial cross-links.

Competitive landscape

Research

Unlock the competitor landscape

Research compares assets by shared mechanism and indication, including each competitor's stage in the relevant market.