Asset profile

Molidustat

Small molecule

Phase 3HIF prolyl hydroxylase (HIF-PH1/2/3)No recent registered activity
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Evidence outlook · lead readout

MIYABI HD-M (NCT03543657) · Anemia, Renal Insufficiency, Chronic

The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.

MIYABI HD-M (NCT03543657): 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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Competitive landscape

67 competitors in this universe: 7 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 25 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Molidustat: this drugPhase 3Small moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
Daprodustat (Jesduvroq)ApprovedSmall moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
Vadadustat (Vafseo)ApprovedSmall moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
AND017Phase 3Small moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
Desidustat (Oxemia)Phase 3Small moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
EnarodustatPhase 3Small moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
Roxadustat (Evrenzo)Phase 3Small moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
SSS17Phase 2Small moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
Atrasentan (Vanrafia)ApprovedSmall moleculeEndothelin A receptor
Avacopan (Tavneos)ApprovedSmall moleculeComplement C5a receptor 1 (C5aR1/CD88)
Baxdrostat (Baxfendy)ApprovedSmall moleculeAldosterone synthase (CYP11B2)
Budesonide (targeted-Release) (TARPEYO / Nefecon)ApprovedSmall moleculeGlucocorticoid receptor
Canagliflozin (Invokana)ApprovedSmall moleculeSGLT2
Dapagliflozin (Farxiga / Forxiga)ApprovedSmall moleculeSGLT2
Difelikefalin (Korsuva)ApprovedPeptideKappa-opioid receptor (agonist, peripherally restricted)
Empagliflozin (Jardiance)ApprovedSmall moleculeSGLT2

…and 52 more. Research shows the complete landscape.

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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

No upcoming readouts on record for this asset.

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 3 (5)
Phase 2 (5)
Phase 1 (5)