Regulatory PathRegulatory requirements compared

Active substances

Bempedoic acid + Ezetimibe

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Bimpdix Plus10,180 mg,mgFilm-coated tablet · Oral use30 BlisterSAR 308.00Generic · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
NEXLIZET180MG;10MGtablet · oralESPERION THERAPS INCPrescription26 Feb 2020

EMA European Union — centrally authorised medicines

Nustendi Daiichi Sankyo Europe GmbH · Authorised · authorised 27 Mar 2020 · ATC C10B

Therapeutic indication (EMA)

Hypercholesterolaemia and mixed dyslipidaemiaNustendi 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 in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe • alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statinCardiovascular diseaseNustendi 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 and not adequately controlled with additional ezetimibe treatment or,• in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or, • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACNEXLIZET 180-10 MG TABLET$13.7964per EA23 Sep 2026
NHS Drug TariffBempedoic acid 180mg / Ezetimibe 10mg tablets£45.3628 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.