Nexletol, Nustendi(bempedoic acid)
Nexletol, Nexlizet, Nilemdo, Nustendi (bempedoic acid) is a small molecule pharmaceutical. Bempedoic acid was first approved as Nexletol on 2020-02-21. It is used to treat atherosclerosis and hyperlipoproteinemia type II in the USA. It has been approved in Europe to treat dyslipidemias and hypercholesterolemia.
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FDA Novel Drug Approvals 2020
Commercial
Trade Name
FDA
EMA
Nexletol
CombinationsNexlizet
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atherosclerosis | EFO_0003914 | D050197 | I25.1 |
| hyperlipoproteinemia type ii | EFO_0004911 | D006938 | E78.00 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BEMPEDOIC ACID, NEXLETOL, ESPERION THERAPS INC | |||
| 2025-02-21 | NCE | ||
BEMPEDOIC ACID / EZETIMIBE, NEXLIZET, ESPERION THERAPS INC | |||
| 2025-02-21 | NCE | ||
| 2023-02-26 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Bempedoic Acid, Nexletol, Esperion Theraps Inc | |||
| 11613511 | 2040-06-19 | DP | |
| 7335799 | 2025-12-03 | DP | |
| 8497301 | 2023-12-23 | U-2746, U-2747 | |
| 9000041 | 2023-12-23 | U-2746, U-2747 | |
| 9624152 | 2023-12-23 | U-2748, U-2749 | |
| 10118881 | 2023-12-23 | U-2746, U-2747 | |
| 10941095 | 2023-12-23 | U-2746, U-2747 | |
| Bempedoic Acid / Ezetimibe, Nexlizet, Esperion Theraps Inc | |||
| 10912751 | 2036-03-14 | U-3224 | |
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AX: Other lipid modifying agents in atc
— C10AX15: Bempedoic acid
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA10: Bempedoic acid and ezetimibe
HCPCS
No data
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 2 | 1 | — | 4 |
| St elevation myocardial infarction | D000072657 | — | — | — | 1 | — | 1 | ||
| Non-st elevated myocardial infarction | D000072658 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | — | 9 | 5 | — | 2 | 16 | |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 1 | 2 | 1 | — | 1 | 5 |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | 3 | — | — | 3 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | HP_0003119 | 1 | 2 | — | — | — | 3 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | — | — | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | BEMPEDOIC ACID |
| INN | bempedoic acid |
| Description | Bempedoic acid is an alpha,omega-dicarboxylic acid that is pentadecanedioic acid which is substituted by methyl groups groups at positions 2 and 14, and by a hydroxy group at position 8. It is a drug used for the treatment of high LDL cholesterol, which is sometimes referred to as 'bad cholesterol'. It has a role as an antilipemic drug, an EC 2.3.3.8 (ATP citrate synthase) inhibitor and a prodrug. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 738606-46-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545313 |
| ChEBI ID | — |
| PubChem CID | 10472693 |
| DrugBank | DB11936 |
| UNII ID | 1EJ6Z6Q368 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 547 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,708 adverse events reported
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