Finerenone is under clinical development by Bayer and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Finerenone’s likelihood of approval (LoA) and phase transition for Diabetic Nephropathy took place on 18 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Finerenone Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Finerenone overview

Finerenone (Kerendia) is a nonsteroidal mineralocorticoid. It is formulated as film coated tablets for oral route of administration. Kerendia is indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes. Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. Kerendia is indicated for the treatment of chronic kidney disease with type 2 diabetes in adults, excluding patients with end-stage renal disease or on dialysis. Kerendia is indicated for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in adults, to reduce the risk of sustained eGFR decline and end-stage kidney disease.

Finerenone (BAY-948862) is under development for the treatment of diabetic nephropathy, diabetic retinopathy, chronic heart failure and chronic kidney disease, proteinuria, glomerulonephritis, hypertension in patients with type 2 diabetes. The drug candidate is administered orally as a tablet. It is a new molecular entity and acts by targeting non-steroidal mineralocorticoid receptor (MR).

It was under development for the treatment of Duchenne muscular dystrophy.

Bayer overview

Bayer is engaged in the discovery, development, manufacturing, and commercialization of products for human health, and agriculture. It provides medicines for cardiovascular diseases, women’s health, cancer, hematology, ophthalmology and other indications. It also strives to develop new molecules and technologies for use in the fields of medicine and modern agriculture. The company’s product portfolio includes prescription products, specialty pharmaceuticals, diagnostic imaging equipment, non-prescription (over the counter or OTC) products, seeds, crop protection solutions and non-agricultural pest control solutions. Bayer markets its healthcare and crop protection products essentially through wholesalers, pharmacies, hospitals and retailers. It operates through a network of subsidiaries in Asia-Pacific, Europe, North America, Latin America, Africa and the Middle East. Bayer is headquartered in Leverkusen, North Rhine-Westphalia, Germany.

Quick View Finerenone LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Finerenone
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Genetic Disorders
  • Genito Urinary System And Sex Hormones
  • Metabolic Disorders
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.