EligibleTrials

Bempedoic acid: clinical trials recruiting now

5
Recruiting trials
14
Conditions studied
2
US states with sites
8
Countries

FDA drug label

FDA-approved
Yes. Bempedoic acid appears in the FDA drug-label database. Marketed as Nexletol.
Drug class
Adenosine Triphosphate-Citrate Lyase Inhibitor (FDA established pharmacologic class)
Mechanism of action
Adenosine Triphosphate-Citrate Lyase Inhibitors (as stated on the FDA label)

FDA-approved use

NEXLETOL is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). NEXLETOL, an adenosine triphosphate-citrate lyase (ACL) inhibitor, is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). ( 1 ) as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hyperch…

FDA recalls / enforcement

Reason (FDA)ClassificationStatusInitiated
Failed dissolution specifications: below specification results at stability 12-month — Esperion Class III (FDA: unlikely to cause harm) Completed 2023-08-16
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint. — Esperion Class III (FDA: unlikely to cause harm) Completed 2024-03-27

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 4 1 Not applicable 3

Conditions being studied

ConditionTrials
High cholesterol · Bempedoic acid for High cholesterol3
Acute Coronary Syndromes1
Atherosclerosis1
Cardiovascular Diseases1
Dyslipidemia1
Dyslipidemias1
HIV1
HIV Infections1
Hypercholesterolemia1
Mixed Dyslipidemia1
NASH1
Non Alcholic Fatty Liver Disease1
Primary Hypercholesterolemiia1
Type 2 Diabetes1

Recruiting trials involving Bempedoic acid

Common questions

Is Bempedoic acid FDA-approved?

Yes, marketed as Nexletol.

How many recruiting trials involve Bempedoic acid?

5 recruiting trials across 14 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.

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