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Details:
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. It is being evaluated for the treatment of chronic kidney disease and type 2 diabetes.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2023
Details:
Kerendia/Firialta (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to block harmful effects of MR overactivation and expands clinical development program investigating finerenone for potential treatment of heart failure.
Lead Product(s): Finerenone
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Kerendia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2023
Details:
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to block harmful effects of MR overactivation, which is investigating for the treatment of heart failure.
Lead Product(s): Finerenone
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Kerendia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CPC Clinical Research
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2023
Details:
Kerendia/Firialta (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to block harmful effects of MR overactivation. It has been granted marketing authorization for expanded indication in China for chronic kidney disease and T2D.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2023
Details:
Kerendia (finerenone) is a non-steroidal mineralocorticoid receptor antagonist and was approved by the FDA to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2023
Details:
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to block harmful effects of MR overactivation. It has been granted marketing authorization for expanded indication in China for chronic kidney disease and T2D.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2023
Details:
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 10, 2023
Details:
Kerendia (finerenone), is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2022
Details:
KERENDIA (finerenone) is indicated to reduce risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with type 2 diabetes.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Kerendia (Finerenone) is non-steroidal, selective MR antagonist that block the harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
The positive data from the pivotal Phase III FIGARO-DKD study demonstrated that Kerendia (finerenone) significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2022
Details:
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2022
Details:
FIDELITY investigated the efficacy and safety of Kerendia (finerenone) across a broad range of patients with early to late-stage CKD and T2D and provided insights into the relationship between CKD stage.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details:
Kerendia (finerenone) non-steroidal, selective mineralocorticoid receptor antagonist, is indicated for treatment of CKD (eGFR of ≥ 25 to 75 mL/min/1.73 m2 with albuminuria) associated with T2D in adults, to reduce risk of sustained eGFR decline and end-stage kidney disease.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2022
Details:
Data from the exploratory post hoc analysis of FIDELITY also highlight the potential of Kerendia™ (finerenone) to reduce the incidence of hospitalization for heart failure (HHF), with a more pronounced effect in patients with left ventricular hypertrophy (LVH) at baseline.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2022
Details:
Data from prespecified subgroup analyses from FIDELITY, a prespecified pooled analysis of Phase III FIDELIO-DKD and FIGARO-DKD trials, indicate that compared to placebo, Kerendia (finerenone) consistently reduced risk of composite CV and kidney outcomes compared with placebo.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
Further analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, explores effect of KERENDIA® on cardiovascular and kidney outcomes in patients with chronic kidney disease associated with type 2 diabetes, with and without history of CV disease.
Lead Product(s): Finerenone
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
FIDELITY investigated the efficacy and safety of Kerendia across the spectrum of patients with CKD and T2D and provided insights into the relationship between CKD stage and the effects of Kerendia on composite cardiovascular and kidney-specific endpoints.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist was granted marketing authorization in the European Union.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
The submission is based on positive data from the FIGARO-DKD study, which demonstrated that Kerendia (finerenone) significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
The primary objective of the study is to demonstrate that the simultaneous initiation and combined use of finerenone and empagliflozin is superior to either empagliflozin alone, or finerenone alone, in reducing urine albumin-to-creatinine ratio (UACR).
Lead Product(s): Finerenone,Empagliflozin
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2022
Details:
The approval is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of Kerendia, selective mineralocorticoid receptor antagonist on kidney and CV outcomes in patients with CKD associated with T2D.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2022
Details:
Finerenone was approved under the brand name Kerendia® by USFDA based on the positive results of the FIDELIO-DKD Phase III study for adult patients with CKD and T2D.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2021
Details:
Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2021
Details:
Compared with placebo, finerenone reduced the risk of the composite CV outcome of time to CV death, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure and was analyzed with and without SGLT2i at baseline.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2021
Details:
Finerenone (BAY 94-8862) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2021
Details:
Kerendia by Bayer Pharmaceuticals, designed to slow chronic kidney disease progression and reduce the risk of kidney failure in adult patients with chronic kidney disease associated with type 2 diabetes.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: American Association of Kidney Patients
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2021
Details:
Finerenone (BAY 94-8862) is a novel, non-steroidal, selective antagonist of the mineralocorticoid receptor (MR) that has been shown to block harmful effects of mineralocorticoid receptor (MR) overactivation.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: Kerendia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2021
Details:
Researchers reported that the trial, called FIDELIO-DKD, met its primary endpoint showing a significant benefit of finerenone, a nonsteroidal, in terms of a composite of sustained decrease in kidney function, kidney failure and renal death.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: BAY94-8862
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2021
Details:
Finerenone significantly reduced the composite primary endpoint of cardiovascular death and non-fatal cardiovascular events versus placebo when added to standard of care.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: BAY94-8862
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2021
Details:
The NDA was based on Phase III FIDELIO-DKD trial data. Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist that showed renal and cardiovascular benefits in patients with CKD and T2D in the Phase III FIDELIO-DKD study.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: BAY 94-8862
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2021
Details:
The FIDELIO-DKD data were presented in October at the American Society of Nephrology’s (ASN) Kidney Week 2020, and simultaneously published in the New England Journal of Medicine. Based on these data, Bayer submitted finerenone for marketing authorization in the US and the EU.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: BAY 94-8862
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
The FIDELIO-DKD study, which evaluated the efficacy and safety of finerenone versus placebo when added to standard of care in patients with CKD and T2D, is the first large contemporary positive outcomes study in patients with CKD and T2D
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: BAY 94-8862
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
The results show that the investigational drug finerenone delayed the progression of CKD by significantly reducing the combined risk of time to first occurrence of kidney failure.
Lead Product(s): Finerenone
Therapeutic Area: Nephrology Product Name: BAY 94-8862
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2020
Details:
FINEARTS-HF is the first large-scale, long-term study to investigate the non-steroidal, selective mineralocorticoid receptor antagonist finerenone on morbidity and mortality outcomes in a heart failure patient population.
Lead Product(s): Finerenone
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
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