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Finerenone - Bayer HealthCare Pharmaceuticals

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Drug Profile

Finerenone - Bayer HealthCare Pharmaceuticals

Alternative Names: BAY-94-8862; Firialta™; KERENDIA; Kerendia

Latest Information Update: 29 Sep 2025

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At a glance

  • Originator Bayer HealthCare Pharmaceuticals
  • Class Amides; Antihyperglycaemics; Heart failure therapies; Naphthyridines; Nitriles; Small molecules; Urologics
  • Mechanism of Action Mineralocorticoid receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Diabetic nephropathies
  • Registered Heart failure
  • Phase III Chronic heart failure; Renal failure; Type 1 diabetes mellitus

Most Recent Events

  • 23 Sep 2025 Bayer plans a phase III FIORE trial for Heart failure and Left-ventricular-dysfunction (In Children, In adolescents, In infants) in Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Finland, Germany, Greece, Hungary, Israel, Italy, Mexico, Poland, Portugal, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom and USA (NCT07188805)
  • 14 Jul 2025 Registered for Heart failure in USA (PO)
  • 17 Mar 2025 Finerenone receives priority review status for Heart failure in USA

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