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Esperion Therapeutics (ESPR) FDA Events

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FDA Events for Esperion Therapeutics (ESPR)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Esperion Therapeutics (ESPR). Over the past two years, Esperion Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as bempedoic and NEXLETOL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Esperion Therapeutics' Drugs in FDA Review

bempedoic acid - FDA Regulatory Timeline and Events

bempedoic acid is a drug developed by Esperion Therapeutics for the following indication: For the Treatment for Hypercholesterolemia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin - FDA Regulatory Timeline and Events

NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin is a drug developed by Esperion Therapeutics for the following indication: Hypercholesterolemia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Esperion Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Esperion Therapeutics (ESPR) has reported FDA regulatory activity for the following drugs: NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin and bempedoic acid.

The most recent FDA-related event for Esperion Therapeutics occurred on May 8, 2025, involving NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin. The update was categorized as "Provided Update," with the company reporting: "HLS Therapeutics partners with Esperion Therapeutics to commercialize NEXLETOL® and NEXLIZET® in Canada"

Current therapies from Esperion Therapeutics in review with the FDA target conditions such as:

  • Hypercholesterolemia - NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
  • For the Treatment for Hypercholesterolemia - bempedoic acid

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ESPR) was last updated on 7/10/2025 by MarketBeat.com Staff
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