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  1. pharmadog
  2. ›drugs
  3. ›Nexletol
drug · small molecule
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bempedoic acid

Marketedupdated 3mo ago
by $ESPR Esperion Therapeutics, Inc.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 5
  • tagApproval54 co-mentions · 18 sources
  • drugNEXLIZET54 co-mentions · 18 sources
  • drugNEXLETOL45 co-mentions · 18 sources
  • tagSmall Molecule27 co-mentions · 18 sources
  • drug(bempedoic acid + ezetimibe)9 co-mentions · 9 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 7 approved and 3 investigational indications.

indications

investigational
Hyperlipidemia

targets

ATP-citrate synthase

all catalysts(9)

approval · 9
Feb 21, 2020
approval
$ESPR
6y ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
Sep 20, 2023
approval
$ESPR
3y ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
Dec 13, 2023
approval
$ESPR
3y ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
Mar 22, 2024
approval
$ESPR
2y ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
Mar 22, 2024
approval
$ESPR
2y ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
Jul 21, 2025
approval
$ESPR
1y ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
Jul 21, 2025
approval
$ESPR
1y ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
Nov 21, 2025
approval
$ESPR
9mo ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
Jan 9, 2026
approval
$ESPR
7mo ago
NEXLETOL (BEMPEDOIC ACID) — FDA approval
bempedoic acid
→
view all 9 catalysts →

Trials studying bempedoic acid

  • —A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemiarecruitingn=2,000
  • phase3A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Eventsnot yet recruitingn=103
  • phase3A Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acidnot yet recruitingn=222
  • —A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemiaactive not recruitingn=2,560
  • phase3A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)completedn=301
  • —Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemiaactive not recruitingn=5,000
  • phase1Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatincompletedn=58
  • phase3A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemiacompletedn=130
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 22, 2027
219 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (7)

  • Jun 19, 2040compositionUS 11613511
  • Jun 19, 2040formulationUS 11760714
  • Jun 19, 2040method-of-use (U-3873)US 11926584
  • Jun 19, 2040compositionUS 12398087
  • Jun 19, 2040compositionUS 12404227
  • Mar 14, 2036method-of-use (U-3883)US 11744816
  • Dec 3, 2030compositionUS 73357994.3y

FDA exclusivities (2)

  • Mar 22, 2027I-943Indication (3y)219d
  • Mar 22, 2027I-944Indication (3y)219d

News(2)

  • Scribe’s Benjamin Oakes on a rare IPO and bringing CRISPR to the masses
    The CEO spoke with BioPharma Dive about convincing investors to buy into the first gene editing IPO in more than two years.
    biopharma_dive · 4d ago
  • Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor
    Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
    biospace · 29d ago
brand
Nexletol
trade names
Bempedoic acid component of nexlizet, Nexletol, Nilemdo
generic
bempedoic acid
MOA
ATP-citrate synthase inhibitor
indication
Heterozygous Familial Hypercholesterolemia (heFH)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 9m ago
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