Probatebeta
Drug

Bempedoic acid

As of the edition of 20 October 2026, Bempedoic acid is a small molecule: marketed, first approved in 2020 (US); acts on ACLY; US protection ends in 2040.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2025
Kind
Small molecule
Brand name
Nexletol
First approved
21 February 2020 (US)
Approvals on record
5 in 3 regions
Holder of the most recent approval
Otsuka; 3 holders in all
Registered trials
46, 1 stopped early
Disease areas
Nutrition and metabolism; Heart and blood vessels; Inherited and neonatal; Hormones; Immune system; Infections

US protection

US protection ends in 2040.

The last listed US drug-substance patent ends in 2040. The application that gives this date is held by Esperion Therapeutics.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

12 listings count towards this date. The exact date and each listing are in the product.

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Companies that need a new molecule because of this drug

3 companies on route B because of this drug.

Companies on route B for this drug

In the product

3 companies are on route B because of Bempedoic acid.

See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.

Target

GeneProteinUniProt
ACLYATP-citrate synthaseP53396

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated4130
Phase 1101000
Phase 2141310
Phase 312930
Phase 46221
All trials46

Who has held its approvals

CompanyRoleYears
Esperion TherapeuticsOriginator and Lead sponsor of trials2010 to now
Daiichi SankyoApplicant and Lead sponsor of trials2020 to now
OtsukaApplicant and Lead sponsor of trials2021 to now

Other marketed drugs held by Otsuka

Otsuka

Other drugs whose US protection ends in 2040