NCT07604064 Olutasidenib IDH1 Mutation Acute Myeloid Leukemia Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07604064 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07604064 is a hot trial to watch
IDH1 Mutation Acute Myeloid Leukemia is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07604064 is notable because it evaluates Olutasidenib in a Phase 2 design sponsored by Kissei Pharmaceutical Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07604064 |
| Official title | A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Olutasidenib |
| Sponsor | Kissei Pharmaceutical Co., Ltd. |
| Geography | Japan |
| Enrollment | [object Object] |
| Primary endpoint | Incidence of adverse events and adverse drug reactions |
| Endpoint time frame | From the start of IMP administration to 28 days after the final dose of the IMP |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This clinical trial is a multicenter, single-arm, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of olutasidenib administered orally twice daily under fasting conditions for one cycle of 28 days in at least 3 Japanese patients with relapsed or refractory IDH1 mutation-positive AML.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across Japan shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Incidence of adverse events and adverse drug reactions (From the start of IMP administration to 28 days after the final dose of the IMP) — The number of events, number of patients, and incidence will be presented for all events, Grade 3 or higher events, Grade 4 or higher events, events resulting in death, serious events excluding death, events resulting in drug withdrawal, and events resulting in drug interruption.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Olutasidenib is indexed as Small molecule drug, with target IDH1, mechanism IDH1 inhibitors, Epigenetic drug, and global highest development status Approved.
Company & Deal Intelligence MCP profile: Kissei Pharmaceutical Co., Ltd. is resolved to a normalized organization record in Matsumoto-shi, Japan. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07604064 provides a focused lens on IDH1 Mutation Acute Myeloid Leukemia development. Its value will be determined by whether Olutasidenib can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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