Head-to-head evidence

BMF-500 vs Gilteritinib

Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.

Acute Myeloid Leukemia

Shared mechanism: FLT3 · full Acute Myeloid Leukemia pipeline

BMF-500

Developed by Biomea Fusion

Phase 1 in Acute Myeloid Leukemia
not yet graded

No graded featured trial for this indication yet; the grade above reflects that absence, not a judgment.

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Gilteritinib

Marketed by Astellas Pharma

Approved in Acute Myeloid Leukemiasmall molecule
Partial signal

NCT02997202 · Phase 3 · completed

This was a randomized, quadruple-blind, placebo-controlled trial with 178 participants per group and a hard clinical primary endpoint of relapse-free survival. The primary endpoint was not statistically significant (hazard ratio 0.679; p=0.0518), so the results provide well-controlled but inconclusive evidence of benefit.

Next expected readout: December 2026 · NCT06001788 (registry estimate)

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The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: BMF-500's landscape · Gilteritinib's landscape