Nilemdo | European Medicines Agency (EMA)

June 28, 2025

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Overview

Nilemdo is a medicine for lowering levels of cholesterol in the blood. It contains the active substance bempedoic acid.

The medicine is used to reduce blood cholesterol levels in adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). Patients taking the medicine are required to be on a low-fat diet.

Nilemdo is also used to reduce the risk of heart problems in adults with, or at high risk for, problems affecting the heart and blood circulation, such as heart attack, stroke or other problems of the circulatory system caused by fatty deposits build up in the walls of the arteries (atherosclerosis).

Nilemdo is used in combination with a statin, with or without other fat-lowering medicines (mainly ezetimibe). Nilemdo can also be used alone or in combination with other fat-lowering medicines without a statin in patients who cannot take statins, or without a statin but with ezetimibe.

Nilemdo blocks an enzyme in the liver called adenosine triphosphate citrate lyase, which is involved in making cholesterol. By blocking this enzyme, Nilemdo reduces blood levels of cholesterol, including low-density lipoprotein (LDL) cholesterol (known as ‘bad’ cholesterol), and other fatty substances made by the liver.

Primary hypercholesterolaemia or mixed dyslipidaemia

Nilemdo effectively reduced LDL cholesterol levels in four main studies involving adults with hypercholesterolaemia or mixed dyslipidaemia, in which Nilemdo was compared with placebo (a dummy treatment).

Two of the studies involved a total of 3,009 patients who were also taking the maximum tolerated doses of statins with or without other fat-lowering medicines. After three months, patients taking Nilemdo had reductions in LDL cholesterol levels of 15% in one study and 17% in the other, while there was a rise in LDL cholesterol levels of around 2% in patients taking placebo in both studies.

The other two studies involved a total of 614 patients who were not able to take a statin or were only taking a low dose. After three months, LDL cholesterol levels in these studies were reduced by 23% and 24% in patients taking Nilemdo compared with a decrease of 1% and an increase of 5% respectively in patients taking placebo.

Atherosclerotic cardiovascular disease

Nilemdo was studied in almost 14,000 adults who were intolerant to statins and who had or were at high risk for cardiovascular disease. After at least 2 years of treatment, 11.7% (819 out of 6,992) of patients given Nilemdo experienced a cardiovascular event (meaning death, heart attack, stroke, or surgery to restore blood flow to the heart), compared with 13.3% (927 out of 6,978) of patients given placebo.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nilemdo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Nilemdo are continuously monitored. Side effects reported with Nilemdo are carefully evaluated and any necessary action taken to protect patients.

Nilemdo received a marketing authorisation valid throughout the EU on 1 April 2020.

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First published: 24/04/2020Last updated: 20/06/2024

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First published: 24/04/2020Last updated: 20/06/2024

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Product information

English (EN)
(1.19 MB – PDF)

First published: 24/04/2020Last updated: 23/06/2025

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Latest procedure affecting product information:
WS2798

08/05/2025

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).

English (EN)
(24.56 KB – PDF)

First published: 24/04/2020Last updated: 20/08/2020

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Product details

Name of medicine

Nilemdo

Active substance

bempedoic acid

International non-proprietary name (INN) or common name

bempedoic acid

Therapeutic area (MeSH)

Hypercholesterolemia
Dyslipidemias

Anatomical therapeutic chemical (ATC) code

C10AX

Pharmacotherapeutic group

Lipid modifying agents

Therapeutic indication

Hypercholesterolaemia and mixed dyslipidaemia

Nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:
• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,
• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

Cardiovascular disease

Nilemdo is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
• in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.

For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.

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Overview

How does Nilemdo work?

What benefits of Nilemdo have been shown in studies?

What are the risks associated with Nilemdo?

Why is Nilemdo authorised in the EU?

What measures are being taken to ensure the safe and effective use of Nilemdo?

Other information about Nilemdo

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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