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nexletol

Generic: bempedoic acid

nexletol: developed by 1 company · 1 FDA decision.

nexletol evidence translation

What we can confirm

What it means

Source-backed records connect nexletol to ESPR; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could nexletol → ESPR affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established CVD, or at high risk for a CVD event but without established CVD, and to reduce LDL-C in adults with primary hyperlipidemia.

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
Esperion Therapeutics, Inc. (ESPR)
Reduce the risk of myocardial infarction and coronary revasc…
Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE 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 i(ESPR)FDA ↗
NDA211616Type 1 - New Molecular EntityStandardOralTablet

Frequently asked questions

Who is developing nexletol?

nexletol is being developed by Esperion Therapeutics, Inc..

What is nexletol's latest FDA decision?

The most recent tracked FDA decision for nexletol is Approval for 1 INDICATIONS AND USAGE 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 i, dated February 21, 2020.