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Kerendia (FINERENONE)
Kerendia works by blocking the mineralocorticoid receptor, a protein that regulates sodium and potassium levels in the body.
Kerendia (Finerenone) is a nonsteroidal Mineralocorticoid-Receptor Antagonist developed by Bayer Healthcare. It targets the mineralocorticoid receptor to treat chronic kidney disease associated with type 2 diabetes. Kerendia is a small molecule modality, FDA-approved in 2021, and remains patented with no generic manufacturers. Key safety considerations include its mechanism of action, which may affect electrolyte levels and kidney function. As a result, patients should be closely monitored for potential side effects.
At a glance
| Generic name | FINERENONE |
|---|---|
| Sponsor | Bayer |
| Drug class | Nonsteroidal Mineralocorticoid-Receptor Antagonist [EPC] |
| Target | Mineralocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2021 |
| Annual revenue | 600 |
Mechanism of action
Finerenone is nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, and blood vessels) tissues. MR overactivation is thought to contribute to fibrosis and inflammation. Finerenone has high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.
Approved indications
- Chronic kidney disease (CKD) associated with type 2 diabetes (T2D)
Common side effects
- Hyperkalemia
- Hypotension
- Hyponatremia
Key clinical trials
- A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
- A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction (PHASE3)
- A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (PHASE3)
- A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction (PHASE3)
- An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea
- An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
- An Observational Study Called FIRST-2.0 China to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions in a Chinese Population.
- A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and Chronic Kidney Disease (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Kerendia CI brief — competitive landscape report
- Kerendia updates RSS · CI watch RSS
- Bayer portfolio CI