Finerenone

General Information

Finerenone Impurities and Finerenone

Daicel Pharma offers the best quality Finerenone impurities, such as Finerenone amide impurity, Finerenone Impurity 15, Finerenone Impurity 4, Finerenone M1, and Finerenone Related Impurity. It is vital for evaluating the quality, stability, and biological safety of Finerenone. In addition, Daicel Pharma specializes in the custom synthesis of Finerenone impurities and ensures their worldwide delivery.

Finerenone [CAS: 1050477-31-0] is a non-steroidal antagonist of the mineralocorticoid receptor (MR). It is a dihydropyridine channel blocker. It treats chronic kidney disease (CKD) associated with Type 2 diabetes (T2D) in adults. It reduces the risk of cardiovascular death, sustained eGFR decline, non-fatal myocardial infarction, and more in patients with CKD and T2D. Further, it treats patients with chronic kidney disease (stages 3 and 4 with albuminuria).

Finerenone: Use and Commercial Availability

Finerenone treats patients with diabetes and kidney disease. It inhibits mineralocorticoids like aldosterone, which regulates blood pressure and sodium retention. In addition, Finerenone lowers the occurrence of hyperkalemia. It helps in reducing hospitalization for heart failure in adult patients with chronic kidney disease with diabetes. Developed by Bayer Healthcare, Finerenone is available as oral tablets under the trade name Kerendia.

Finerenone Structure and Mechanism of Action

The chemical name of Finerenone is (4S)-4-(4-Cyano-2-methoxyphenyl)-5-ethoxy-1,4-dihydro-2,8-dimethyl-1,6-naphthyridine-3-carboxamide. The chemical formula for Finerenone is C₂₁H₂₂N₄O₃, and its molecular weight is approximately 378.43 g/mol.

Aldosterone and cortisol activate Finerenone, which regulates gene transcription. Finerenone blocks mineralocorticoid receptor (MR). It prevents sodium reabsorption and overaction in epithelial and nonepithelial tissues.

Finerenone Impurities and Synthesis

Impurities may form during the synthesis of Finerenone ¹ that affect its safety, efficacy, and shelf-life. They form during the synthesis, storage, or degradation² of Finerenone. It is necessary to control and monitor the impurities of Finerenone to improve the drug safety, efficacy, and storage.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Finerenone impurities, which includes Finerenone amide impurity, Finerenone Impurity 15, Finerenone Impurity 4, Finerenone M1, and Finerenone Related Impurity. The CoA is from a cGMP-compliant analytical facility. It contains the complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We give additional data like 13C-DEPT and CHN on request. Daicel Pharma can prepare any unidentified Finerenone impurity or degradation product. In addition, Daicel Pharma offers highly purified deuterium-labeled standard of Finerenone-D5 for bioanalytical research and BA/BE efficacy studies. We also provide a complete characterization report on delivery.