Kerendia
Authorised
This medicine is authorised for use in the European Union
finerenone
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Kerendia is a medicine used to treat chronic (long-term) kidney disease in adults with type 2 diabetes. It is used for patients with kidney damage who pass albumin (a type of protein) in their urine.
Kerendia is also used to treat chronic heart failure (when the heart does not pump blood as well as it should) with left ventricular ejection fraction (LVEF) ≥ 40% in adults (a measure of how well the heart pumps blood).
Kerendia contains the active substance finerenone.
Kerendia can only be obtained with a prescription.
Kerendia is available as tablets to be taken by mouth once a day. The dose depends on the condition Kerendia is used for, and on the patient’s kidney function.
For more information about using Kerendia, see the package leaflet or contact your doctor or pharmacist.
The active substance in Kerendia, finerenone, binds to a receptor (target) known as mineralocorticoid receptor (MR). MR is involved in the activation of processes that cause inflammation and scarring in the heart and kidneys. By binding to MR, Kerendia blocks the start of these processes, leading to improvements of kidney and heart damage.
Chronic kidney disease
Kerendia, in addition to standard treatment, was shown to be effective at slowing down kidney disease in two main studies. The first study involved 5,662 patients with chronic kidney disease and type 2 diabetes. In this study, 18% of patients taking Kerendia (498 out of 2,824) experienced a loss of kidney function compared with 21% of patients taking a placebo (a dummy treatment) (600 out of 2,838).
Another study in 7,328 patients with chronic kidney disease showed that Kerendia was effective at reducing the risk of patients having a heart attack, a stroke, being hospitalised for heart failure or dying from heart problems. In the study, 12% of patients taking Kerendia (457 out of 3,674) experienced serious heart‑related problems or died from cardiovascular causes compared with 14% of patients taking placebo (518 out of 3,654).
Chronic heart failure
Kerendia was compared with placebo in a main study involving 6,001 adults with heart failure with LVEF ≥ 40%. Over an average duration of treatment of 28 months, 21% (624 out of 3,003) of patients treated with Kerendia either died as a result of heart and circulation problems or were admitted to hospital or had an urgent medical visit due to heart failure, compared to 24% (719 out of 2,998) of patients on placebo.
For the full list of side effects and restrictions with Kerendia, see the package leaflet.
The most common side effect with Kerendia (which may affect more than 1 in 10 people) is hyperkalaemia (high potassium levels in the blood). Other common side effects, which may affect up to 1 in 10 people, include low blood levels of sodium, high blood levels of uric acid, low blood pressure, itching and loss of kidney function.
Kerendia must not be used in patients with Addison’s disease (a condition that prevents the body from producing enough of the hormones cortisol and aldosterone). It must also not be used with certain medicines that strongly block the effects of CYP3A4, a liver enzyme that helps the body process many medicines.
Kerendia was shown to slow down loss of kidney function in adults with chronic kidney disease and type 2 diabetes, and to reduce the occurrence of heart failure events and death from cardiovascular causes in patients with chronic heart failure. Overall, the medicine’s side effects were considered manageable with regular monitoring of kidney function.
Therefore, the European Medicines Agency decided that Kerendia’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kerendia have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Kerendia are continuously monitored. Side effects reported with Kerendia are carefully evaluated and any necessary action taken to protect patients.
Kerendia received a marketing authorisation valid throughout the EU on 16 February 2022.
Product information
Latest procedure affecting product information:X/0000248026
26/03/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Kerendia
- Active substance
- finerenone
- International non-proprietary name (INN) or common name
- finerenone
- Therapeutic area (MeSH)
- Renal Insufficiency, Chronic
- Diabetes Mellitus, Type 2
- Heart Failure
- Anatomical therapeutic chemical (ATC) code
- C09
Pharmacotherapeutic group
Agents acting on the renin-angiotensin systemTherapeutic indication
Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults.
For study results with respect to renal and cardiovascular events, see section 5.1.
Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.
News on Kerendia
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