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Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Hyperlipidemias

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Drug Information

Target Indication

Hyperlipidemias

Clinical Trial

NCT03337308

Last updated: 12/4/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA4/1/2020

Nilemdo

Hypercholesterolaemia and mixed dyslipidaemiaNilemdo 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 diseaseNilemdo 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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Drug Science
Mechanism of action & safety profile
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