Asset profile

Balcinrenone

Small molecule

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Phase 3underway

Evidence outlook · registrational

Chronic Kidney Disease: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2030-07-01.

MIRACLE (NCT04595370): The trial was randomized and quadruple-blind, with dapagliflozin as the active comparator, but the primary endpoint was the surrogate biomarker UACR rather than a clinical heart-failure or kidney outcome. The primary comparison was not statistically significant, and the study had relatively small analyzed groups after placebo and AZD9977 monotherapy arms were removed early.

Also in development:Heart Failure · Phase 3

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Competitive landscape

111 competitors in this universe: 1 direct rival (same mechanism and indication), 1 same-class, 109 same-indication; 34 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Balcinrenone: this drugPhase 3Small moleculeMineralocorticoid receptor
Finerenone (Kerendia)ApprovedSmall moleculeMineralocorticoid receptor
Esaxerenone (Minnebro)Phase 3Small moleculeMineralocorticoid receptor
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
Daprodustat (Jesduvroq)ApprovedSmall moleculeHIF prolyl hydroxylase (HIF-PH1/2/3)
Difelikefalin (Korsuva)ApprovedPeptideKappa-opioid receptor (agonist, peripherally restricted)
Empagliflozin (Jardiance)ApprovedSmall moleculeSGLT2
Etelcalcetide (Parsabiv)ApprovedPeptideCalcium-sensing receptor (CaSR), allosteric agonist on parathyroid chief cells
Extended-Release Calcifediol (Rayaldee)ApprovedSmall moleculeVitamin D receptor (VDR), via conversion to calcitriol
Ferric Carboxymaltose (Injectafer / Ferinject)ApprovedIron Complex (iv)Iron repletion
Ferric Derisomaltose (Monoferric / Monofer)ApprovedIron Complex (iv)Iron repletion

…and 96 more. Research shows the complete landscape.

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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

(3 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
December 2026 (1)
Phase 1Kidney FailureRecruiting
Est. primary completion 2026-12-03 · NCT07754331 · CT.gov ↗
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2027 (1)
April 2027 (1)
Phase 3Heart FailureRecruiting
Est. primary completion 2027-04-16 · NCT06307652 · CT.gov ↗
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2030 (1)
July 2030 (1)
Phase 3Chronic Kidney DiseaseRecruiting
Est. primary completion 2030-07-01 · NCT07624305 · CT.gov ↗
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See the full readout calendar ↗

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 (2)
Phase 2 (3)
Phase 1 (16)