Asset profile

Olutasidenib

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: Weak signal

How the evidence outlook works ↗

Upcoming events

(6 total)

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

2027 (1)
December 2027 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-12-01 · NCT07304011 · CT.gov ↗
What to watch

Research analysis

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

2028 (1)
June 2028 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-06 · NCT07471841 · CT.gov ↗
What to watch

Research analysis

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

2029 (2)
March 2029 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-03-31 · NCT06782542 · 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 (1)
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.

2030 (2)
April 2030 (1)
Phase 2Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2030-04-26 · NCT07153497 · CT.gov ↗
What to watch

Research analysis

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

September 2030 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2030-09 · NCT07604064 · 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

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Competitive landscape

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