bempedoic acid
Trade name: NEXLETOL
Approved
Feb 21, 2020
Bempedoic acid, sold under the brand name Nexletol among others, is a medication for the treatment of hypercholesterolemia. — Wikipedia
Clinical trial activity
44 trials · 27 clinical orgs · 1 marketing orgs
Earliest trial started Apr 1, 2010 (NCT01105598)
Timeline
2010s
- Jan 1, 2010
Esperion Therapeutics — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2010
Esperion Therapeutics — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2016
Esperion Therapeutics — Earliest Phase 3 Sponsor(trial)
2020s
- Feb 21, 2020
Esperion Therapeutics — Earliest FDA Approval
- Feb 21, 2020
Esperion Therapeutics — NDA Secondary Org
- Feb 21, 2020
Esperion Therapeutics — NDA Organization
Indications
Approved for
Studied for
- Atherosclerosis · Phase 3
- Cardiovascular Diseases · Phase 4
- Diabetes Mellitus · Phase 2
- Diabetes Mellitus, Type 2 · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Dyslipidemias · Phase 4
- Healthy Volunteers · Phase 4
- HIV Infections · Phase 3
- Hypercholesterolemia · Phase 3
- Hyperlipidemias · Phase 3
- Hypertension · Phase 2
- Lipid Metabolism Disorders · Phase 4
- Non-ST Elevated Myocardial Infarction · Phase 4
- Pharmacological and Toxicological Phenomena · Phase 1
- ST Elevation Myocardial Infarction · Phase 4
Mechanism of action
- Isocitrate lyaseANTAGONIST
ICL1 antagonist
- ATP-citrate synthaseINHIBITOR
ATP-citrate synthase inhibitor
Bempedoic acid is activated to a CoA-ester that inhibits ACL. ACL is upstream of HMG-CoA, an enzyme involved in the cholesterol biosynthesis pathway. Overall, bempedoic acid lowers low-density lipoprotein cholesterol by inhibition of cholesterol synthesis in the liver.
Combination products
nexlizet
with ezetimibe
Approval history
- approvedFeb 21, 2020
Chemistry & pharmacology
SMILES
CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O- Mol. weight
- 344.49 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3545313 ↗
- WikipediaBempedoic acid ↗
Also known as
- 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
- bempedoic acid
- bempedoic acid
- bempedoic acid
- bempedoic acid
- esp55016
- etc-1002
- etc-1002
- etc-1002
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07282821 | Phase 2 | Feb 1, 2026 | Biomedical Research Institute of New Mexico, Tufts University, University of Maryland, University of Pittsburgh, University of Southern California, University of Vermont |
| NCT07268625 | Phase 1 | Jan 5, 2026 | Daiichi Sankyo |
| NCT07255820 | Phase 4 | Jan 1, 2026 | Bahria University |
| NCT07239414 | Phase 3 | Nov 10, 2025 | Sheikh Zayed Medical College |
| NCT07235189 | Phase 1 | Oct 28, 2025 | Daiichi Sankyo |
| NCT07201545 | Phase 1 | Oct 7, 2025 | Daiichi Sankyo |
| NCT07182383 | Phase 1 | Sep 29, 2025 | Daiichi Sankyo |
| NCT07170852 | Phase 1 | May 21, 2025 | Humanis Saglık Anonim Sirketi |
| NCT06925100 | Phase 4 | Apr 1, 2025 | Daiichi Sankyo |
| NCT06780410 | Phase 3 | Dec 20, 2024 | Gan and Lee Pharmaceuticals, USA |
| NCT06742853 | Phase 1 | Dec 20, 2024 | AstraZeneca |
| NCT06923956 | Phase 1 | Dec 4, 2024 | Humanis Saglık Anonim Sirketi |
| NCT06450366 | Phase 3 | Jul 8, 2024 | Merck |
| NCT06381947 | Phase 4 | May 1, 2024 | University of Salerno |
| NCT05587621 | N/A | Apr 1, 2024 | Friedrich Schiller University, University of Jena |
| NCT06035874 | N/A | Oct 15, 2023 | Diabetes & Endocrinology Foundation, Medanta - The Medicity |
| NCT06021951 | Phase 4 | Aug 4, 2023 | Esperion Therapeutics |
| NCT05687071 | Phase 3 | Feb 27, 2023 | Otsuka |
| NCT05683340 | Phase 3 | Feb 13, 2023 | Otsuka |
| NCT05694260 | Phase 2 | Jan 12, 2023 | Esperion Therapeutics |
Organizations
Research & Development (27)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Esperion Therapeutics | For profit | 24 | 23 | 4 | 2010 |
| Daiichi Sankyo | For profit | 5 | 5 | 2 | 2025 |
| Medpace, Inc. | For profit | 3 | 0 | 1 | 2013 |
| Otsuka | For profit | 3 | 3 | 2 | 2021 |
| Humanis Saglık Anonim Sirketi | Academic/Hospital | 2 | 2 | 1 | 2024 |
| AstraZeneca | For profit | 1 | 1 | 1 | 2024 |
| Bahria University | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Biomedical Research Institute of New Mexico | Academic/Hospital | 1 | 0 | 1 | 2026 |
| Diabetes & Endocrinology Foundation | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Friedrich Schiller University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Gan and Lee Pharmaceuticals, USA | For profit | 1 | 1 | 1 | 2024 |
| Harvard University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Kaiser Permanente | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Medanta - The Medicity | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Merck | For profit | 1 | 1 | 1 | 2024 |
| Quotient | For profit | 1 | 0 | 1 | 2013 |
| Sheikh Zayed Medical College | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Tufts University | Academic/Hospital | 1 | 0 | 1 | 2026 |
| University of California, Los Angeles | Academic/Hospital | 1 | 0 | 1 | 2022 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2022 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Esperion Therapeutics | For profit | NDA2 | Feb 21, 2020 |
| Esperion Therapeutics | For profit | NDA | Feb 21, 2020 |