Bempedoic acid: clinical trials recruiting now
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) | Classification | Status | Initiated |
|---|---|---|---|
| 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 |
Phase breakdown
Conditions being studied
Recruiting trials involving Bempedoic acid
- A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
- Early Triple Lipid-Lowering Therapy With Bempedoic Acid After Acute Coronary Syndrome
- Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes
- Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy
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.