Finerenone, marketed under the brand name Kerendia among others, is a

medication Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...

used to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type2 diabetes. Finerenone is a non-steroidal mineralocorticoid receptor antagonist. It is taken orally (swallowed by mouth). Common side effects include abnormally high levels of potassium in the bloodstream, abnormally low levels of sodium in the bloodstream, and abnormally low blood pressure. Finerenone was approved for medical use in the United States in July 2021, and in the European Union in February 2022. The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

considers it to be a first-in-class medication.

Medical uses

In the United States, finerenone is indicated to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with

chronic kidney disease Chronic kidney disease (CKD) is a type of long-term kidney disease, defined by the sustained presence of abnormal kidney function and/or abnormal kidney structure. To meet criteria for CKD, the abnormalities must be present for at least three mo ...

associated with type2 diabetes. In the European Union, finerenone is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type2 diabetes in adults.

Pharmacology

Finerenone has less relative affinity to other steroid hormone receptors than currently available aldosterone antagonists such as eplerenone and spironolactone, which should result in fewer adverse effects like gynaecomastia,

impotence Erectile dysfunction (ED), also referred to as impotence, is a form of sexual dysfunction in males characterized by the persistent or recurring inability to achieve or maintain a Human penis, penile erection with sufficient rigidity and durat ...

, and low libido. This table compares inhibitory (blocking) concentrations ( IC₅₀, unit: nM) of three antimineralocorticoids. Mineralocorticoid receptor inhibition is responsible for the desired action of the drugs, whereas inhibition of the other receptors potentially leads to side effects. Lower values mean stronger inhibition. Finerenone acts as an antagonist to mineralocorticoid receptors harboring the S810L mutation, unlike other traditional inhibitors of mineralocorticoids such as spironolactone and eplerenone that incidentally act as agonists. A meta-analysis of data from seven randomized controlled trials (13,783 participants) found a benefit to using finerenone in people with diabetic kidney disease and overt proteinuria.

Adverse effects

Finerenone may cause electrolyte imbalances. Symptoms that correlate with higher levels of potassium include nausea, weakness, chest pain, and loss of movement. People with lower levels of sodium may experience headaches, confusion, weakness, and feeling off balance.

History

The efficacy of finerenone to improve kidney and heart outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease associated with type2 diabetes. In this study, 5,674 participants were randomly assigned to receive either finerenone or a placebo. The study compared the two groups for the number of participants whose disease progressed to a composite (or combined) endpoint that included at least a 40% reduction in kidney function, progression to kidney failure, or kidney death. Results showed that 504 of the 2,833 participants who received finerenone had at least one of the events in the composite endpoint compared to 600 of the 2,841 participants who received a placebo. The US

(FDA) granted the application for finerenone priority review and fast track designations. The FDA granted the approval of Kerendia to Bayer Healthcare.

Legal status

In December 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kerendia, intended for the treatment of chronic kidney disease associated with type2 diabetes in adults. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Finerenone was approved for medical use in the European Union in February 2022.

Brand names

Finerenone is sold under the brand names Kerendia and Firialta.

Research

In a phase II study, finerenone reduced urine albumin to creatinine ratio in patients with diabetic kidney disease. Based on that finding, it is being studied in phase studies designed to assess whether it reduces risk of progression of chronic kidney disease and adverse cardiovascular events in patients with type 2 diabetes. These studies have enrolled more than 13,000 patients with primary completion anticipated in 2020 and 2021.