Asset profile

Olutasidenib

Small molecule

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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: Weak signal

Featured evidence outside covered markets:NCT06161974 · High Grade Glioma · Phase 2 · ungraded

How the evidence outlook works ↗

Competitive landscape

61 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Olutasidenib: this drugApprovedSmall moleculeMutant IDH1
IvosidenibPhase 3Small moleculeMutant IDH1
ASTX727ApprovedSmall moleculeDecitabine/cedazuridine fixed combination (DNMT + CDA inhibition)
EnasidenibApprovedSmall moleculeIDH2
Gemtuzumab OzogamicinApprovedAntibody–drug conjugateCD33
GilteritinibApprovedSmall moleculeFLT3
MidostaurinApprovedSmall moleculeFLT3;KIT;PKC;PDGFR
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
AK117Phase 3Monoclonal antibodyCD47
APG-2575(Lisaftoclax )Phase 3Small moleculeBCL-2
AzacitidinePhase 3Small moleculeDNMT1 (DNA methyltransferase 1)

…and 46 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

(15 total)

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

2027 (8)
January 2027 (1)
Phase 1Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2027-01-14 · NCT07411586 · CT.gov ↗
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February 2027 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-02-05 · NCT06543381 · CT.gov ↗
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April 2027 (1)
Phase 4Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-04-30 · NCT07486713 · CT.gov ↗
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June 2027 (2)
Phase 2Targeted Therapy, IDH1-Mutated Malignancies, MutationsRecruiting
Est. primary completion 2027-06-01 · NCT07032727 · CT.gov ↗
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Phase 1/2Mutant IDH1 Inhibitor OlutasidenibRecruiting
Est. primary completion 2027-06-30 · NCT06445959 · CT.gov ↗
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August 2027 (1)
Phase 2Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Clonal Cytopenia of Undetermined SignificanceRecruiting
Est. primary completion 2027-08-31 · NCT06566742 · CT.gov ↗
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December 2027 (2)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-12-01 · NCT07304011 · CT.gov ↗
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Phase 2Myeloid MalignanciesRecruiting
Est. primary completion 2027-12-31 · NCT06668584 · CT.gov ↗
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2028 (2)
June 2028 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-06 · NCT07471841 · CT.gov ↗
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October 2028 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-10-31 · NCT07130695 · CT.gov ↗
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2029 (3)
March 2029 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-03-31 · NCT06782542 · CT.gov ↗
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May 2029 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2029-05-15 · NCT05564390 · CT.gov ↗
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June 2029 (1)
Phase 2High Grade Glioma, Astrocytoma, Astrocytoma, Grade III, Astrocytoma, Grade IV, Diffuse Intrinsic Pontine Glioma, WHO Grade III Glioma …Recruiting
Est. primary completion 2029-06 · NCT06161974 · CT.gov ↗
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2030 (2)
April 2030 (1)
Phase 2Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2030-04-26 · NCT07153497 · CT.gov ↗
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September 2030 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2030-09 · NCT07604064 · 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 2 (11)
Phase 1/2 (4)
Phase 1 (3)
Phase 4 (1)