Head-to-head evidence

Molidustat vs Roxadustat

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.

Chronic Kidney Disease

Shared mechanism: HIF prolyl hydroxylase (HIF-PH1/2/3) · full Chronic Kidney Disease pipeline

Molidustat

Developed by Bayer

Phase 3 in Chronic Kidney Diseasesmall molecule
Partial signal

NCT03543657 · Phase 3 · completed

The trial randomized 229 participants to molidustat or darbepoetin alfa with matching placebos and quadruple blinding. Its primary endpoints were hemoglobin measures, which are laboratory surrogate outcomes, and no primary results or statistical comparison are available.

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Roxadustat · Evrenzo

Marketed by Astellas Pharma and partners

Phase 3 in Chronic Kidney Diseasesmall molecule
Reliable signal

NCT01750190 · Phase 3 · completed

This was a randomized, quadruple-blind, placebo-controlled Phase 3 trial in 922 non-dialysis CKD patients with anemia. The two primary efficacy endpoints—mean change in hemoglobin over weeks 28-52 and hemoglobin response during the first 24 weeks—were both statistically significant and strongly favored roxadustat over placebo (p<0.0001 for both). The study was adequately powered and used a hard hemoglobin-based clinical endpoint, supporting a strong design and result.

Next expected readout: October 2027 · NCT05970172 (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: Molidustat's landscape · Roxadustat's landscape