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Kerendia
Published
Product name
Kerendia
Active ingredient
Finerenone
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Kerendia (finerenone) was approved for the following therapeutic use:
Kerendia is indicated to delay progressive decline of kidney function in adults with chronic kidney disease associated with Type 2 diabetes (with albuminuria), in addition to standard of care (see Section 5.1 Pharmacodynamic properties, clinical trials).
How this medicine works
Finerenone is a nonsteroidal antagonist of the mineralocorticoid receptor (MR) that potently attenuates inflammation and fibrosis mediated by MR overactivation. The MR is expressed in the kidneys, heart and blood vessels where finerenone also counteracts sodium retention and hypertrophic processes. Finerenone has high selectivity for the MR due to its nonsteroidal structure and bulky binding mode. Finerenone has no relevant affinity for androgen, progesterone, estrogen and glucocorticoid receptors and therefore does not cause sex hormone related adverse events (for example, gynecomastia). Its binding to the MR leads to a specific receptor ligand complex that blocks recruitment of transcriptional coactivators implicated in the expression of pro-inflammatory and pro-fibrotic mediators.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Kerendia was considered favourable for the therapeutic use approved.
Sponsor