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Lomonitinib · ZE46

Small molecule · Inhibitor of FLT3 and IRAK4

Phase 2/3 Most advanced trial

1 Registered trials

What is Lomonitinib?

Lomonitinib is an orally bioavailable inhibitor of FLT3 mutations and IRAK4. It selectively inhibits FLT3-mutant forms, including the FLT3-ITD-F691L gatekeeper mutation, while sparing wild-type FLT3, and inhibits IRAK4-mediated signaling to reduce adaptive resistance to FLT3 inhibition. It is studied in acute myeloid leukemia.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: ZE46
Drug type: Small molecule
Targets: FLT3, IRAK4
Mechanism: Inhibitor of FLT3 and IRAK4
Pathways: TLR signaling, IL-1R signaling
Therapy area: Hematology, Oncology
In trials of: SNDX
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 2/3
UNII: U4DPU7W7QU

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT03013998	Phase 2/3	Previously Untreated Relapsed Refractory Acute Myeloid Leukemia	Recruiting	SNDX

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Other drugs acting on FLT3 / IRAK4

Gilteritinib FDA approved Midostaurin FDA approved Pexidartinib FDA approved BMF-500 Phase 1 CDX-301 Phase 2 CLN-049 Phase 1 Dapolsertib Phase 1/2 Emavusertib Phase 1/2

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z