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    Chemistry

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    Also known as: Etc-1002, 738606-46-7, 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid, Nexletol, Esp-55016, Nilemdo
    Molecular Formula
    C19H36O5
    Molecular Weight
    344.5  g/mol
    InChI Key
    HYHMLYSLQUKXKP-UHFFFAOYSA-N
    FDA UNII
    1EJ6Z6Q368
    Bempedoic Acid
    High levels of LDL cholesterol (LDL-C) are a major risk factor for cardiovascular events. Caused by genetic mutations or lifestyle factors, hypercholesterolemia can significantly reduce quality of life and increase the risk of mortality from cardiovascular disease. About 1 in 4 patients, or 15 million Americans with elevated LDL-C, are insufficiently managed with maximally tolerated statin therapy alone, requiring additional treatment for hypercholesterolemia. Bempedoic acid is first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor used once a day for reducing LDL cholesterol levels in statin-refractory patients. It was developed by Esperion Therapeutics Inc. and approved by the FDA on February 21, 2020. A combination product of bempedoic acid and [ezetimibe] was approved on February 26, 2020 for increased control of LDL cholesterol levels in patients experiencing refractory elevations despite previous statin treatment.
    Bempedoic acid is an Adenosine Triphosphate-Citrate Lyase Inhibitor. The mechanism of action of bempedoic acid is as an Adenosine Triphosphate-Citrate Lyase Inhibitor.
    1 2D Structure

    Bempedoic Acid

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
    2.1.2 InChI
    InChI=1S/C19H36O5/c1-18(2,16(21)22)13-9-5-7-11-15(20)12-8-6-10-14-19(3,4)17(23)24/h15,20H,5-14H2,1-4H3,(H,21,22)(H,23,24)
    2.1.3 InChI Key
    HYHMLYSLQUKXKP-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C)(CCCCCC(CCCCCC(C)(C)C(=O)O)O)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    1EJ6Z6Q368
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic Acid

    2. Esp-55016

    3. Esp55016

    4. Etc-1002

    5. Nexletol

    6. Nilemdo

    2.3.2 Depositor-Supplied Synonyms

    1. Etc-1002

    2. 738606-46-7

    3. 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic Acid

    4. Nexletol

    5. Esp-55016

    6. Nilemdo

    7. Etc1002

    8. Etc 1002

    9. Esp 55016

    10. 1ej6z6q368

    11. Mfcd18800820

    12. Etc-1002;esp-55016

    13. Pentadecanedioic Acid, 8-hydroxy-2,2,14,14-tetramethyl-

    14. Bempedoate

    15. Unii-1ej6z6q368

    16. Bempedoic Acid [usan:inn]

    17. Bempedoic-acid

    18. Bempedoic Acid

    19. Esp-55016

    20. Acido Bempedoico

    21. Acide Bempedoique

    22. Acidum Bempedoicum

    23. Nexletol (tn)

    24. Bempedoic Acid (usan/inn)

    25. Bempedoic Acid [inn]

    26. Bempedoic Acid [jan]

    27. Bempedoic Acid [usan]

    28. Schembl185768

    29. Gtpl8321

    30. Bempedoic Acid [who-dd]

    31. Chembl3545313

    32. Chebi:149601

    33. Dtxsid401027952

    34. Amy31933

    35. Bcp16083

    36. Esp55016

    37. Ex-a1243

    38. Zinc3948738

    39. Bempedoic Acid [orange Book]

    40. S7953

    41. Akos027439916

    42. Ccg-267969

    43. Cs-3952

    44. Db11936

    45. Nexlizet Component Bempedoic Acid

    46. Ac-29040

    47. As-49804

    48. Hy-12357

    49. Sy244715

    50. Bempedoic Acid Component Of Nexlizet

    51. Bempedoic Acid(etc-1002;esp-55016)

    52. Db-108321

    53. D10691

    54. N10681

    55. A905695

    56. Q27075007

    57. 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic Acid;etc-1002

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 344.5 g/mol
    Molecular Formula C19H36O5
    XLogP34.8
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count14
    Exact Mass344.25627424 g/mol
    Monoisotopic Mass344.25627424 g/mol
    Topological Polar Surface Area94.8 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity351
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Bempedoic acid is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease that warrants additional lowering of LDL-C. The combination of bempedoic and ezetimibe is also indicated with diet management and maximally tolerated statin therapy to treat elevated LDL-C levels in adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease who require further lowering of LDL-C.

    FDA Label

    Nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:

    - in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4. 2, 4. 3, and 4. 4) or,

    - alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Bempedoic acid inhibits the synthesis of cholesterol in the liver, reducing LDL-C levels. This reduces the development of atherosclerotic plaques that may increase the risk of cardiovascular events. Earlier clinical trials studying the effects of bempedoic acid showed a dosedependent reduction of LDLC levels in addition to decreased LDL particle number, and reduced levels of apolipoprotein B, nonHDL cholesterol, and highsensitivity Creactive protein. Due to its unique mechanism of action, bempedoic acid is not associated with myositis, an adverse effect that frequently accompanies statin therapy. More recent trials have supported that this drug significantly decreases LDL-C levels after 12 weeks of therapy and provides additional lowering of LDL-C when combined with ezetimibe and statin therapy. The effects of bempedoic acid on mortality are currently unknown.

    5.2 MeSH Pharmacological Classification

    Enzyme Inhibitors

    Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

    Hypoglycemic Agents

    Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)

    Hypolipidemic Agents

    Substances that lower the levels of certain LIPIDS in the BLOOD. They are used to treat HYPERLIPIDEMIAS. (See all compounds classified as Hypolipidemic Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    BEMPEDOIC ACID
    5.3.2 FDA UNII
    1EJ6Z6Q368
    5.3.3 Pharmacological Classes
    Adenosine Triphosphate-Citrate Lyase Inhibitors [MoA]; Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC]
    5.4 ATC Code

    C10AX

    C - Cardiovascular system

    C10 - Lipid modifying agents

    C10A - Lipid modifying agents, plain

    C10AX - Other lipid modifying agents

    C10AX15 - Bempedoic acid

    5.5 Absorption, Distribution and Excretion

    Absorption

    Bempedoic acid is rapidly absorbed in the small intestine. The Tmax of the 180mg tablet is estimated at 3.5 hours.

    Route of Elimination

    Bempedoic acid's conjugates are primarily eliminated via the urine (70%) and the feces (30%). A total of 5% of the unchanged drug is excreted in the urine and feces, combined.

    Volume of Distribution

    The apparent volume of distribution of bempedoic acid is about 18L.

    Clearance

    The clearance (CL/F) of bempedoic acid at steady state was estimated at 11.2 mL/min during clinical trials.

    5.6 Metabolism/Metabolites

    The two main metabolites of bempedoic metabolism are ETC-1002-CoA and ESP15228. Bempedoic acid is primarily eliminated via the metabolism of its acyl glucuronide. This drug is reversibly converted to an active metabolite (ESP15228) based on observations during in vitro studies. Both compounds resulting from the metabolism of bempedoic acid are metabolized to become inactive glucuronide conjugates by the enzyme UGT2B7.

    5.7 Biological Half-Life

    The half-life of bempedoic acid ranges between 15 and 24 hours. Prescribing information indicates a clearance of 21 hours +/- 11 hours.

    5.8 Mechanism of Action

    Normally, LDL cholesterol is produced in the liver and circulates in the blood. When the blood becomes saturated, excess LDL deposits in blood vessels including the coronary arteries, increasing the risk of cardiovascular events. Bempedoic acid is a prodrug that requires activation in the liver. The very-long-chain acyl-CoA synthetase-1 (ACSVL1) enzyme is responsible for its activation to ETC-1002-CoA, the pharmacologically active metabolite. ATP lyase (also known as ATP synthase) plays an important part of cholesterol synthesis. BETC-1002-CoA directly inhibits this enzyme after the parent drug is activated in the liver by coenzyme A (CoA). This inhibition leads to upregulation of the LDL cholesterol receptor, reducing serum LDL-C via increased uptake and LDL clearance in the liver. By the above mechanisms, bempedoic acid causes a total decrease of circulating LDL-C that normally damages blood vessels and leads to atherosclerosis. Lastly, ETC-1002 activates AMP-activated protein kinase (AMPK) in rodents, which inhibits the synthesis of cholesterol via the inhibition of HMG-CoA reductase. The relevance of this to humans is unknown.

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007-24BAPS,","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"ESPERION THERAPEUTICS INC","supplierCountry":"FRANCE","foreign_port":"LYON","customer":"PIRAMAL PHARMA LTD","customerCountry":"INDIA","quantity":"210.30","actualQuantity":"210.3","unit":"KGS","unitRateFc":"1100","totalValueFC":"233487.1","currency":"USD","unitRateINR":"95040","date":"30-Apr-2025","totalValueINR":"19986912","totalValueInUsd":"233487.1","indian_port":"Bombay Air","hs_no":"29181990","bill_no":"9791922","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"LYON","supplierAddress":"3891 RANCHERO DRIVE, SUITE 150, ANN ARBOR, MI 48108 SDNF UNITED STATES","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746556200,"product":"BEMPEDOIC ACID - CORDEN, API, BO2408B096, BEMPEDOIC ACID - CORDEN, API, 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    24-Jan-2022
    27-Jun-2025
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    Cohance Lifesciences

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    ABOUT THIS PAGE

    Looking for 738606-46-7 / Bempedoic Acid API manufacturers, exporters & distributors?

    Bempedoic Acid manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Bempedoic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bempedoic Acid manufacturer or Bempedoic Acid supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bempedoic Acid manufacturer or Bempedoic Acid supplier.

    PharmaCompass also assists you with knowing the Bempedoic Acid API Price utilized in the formulation of products. Bempedoic Acid API Price is not always fixed or binding as the Bempedoic Acid Price is obtained through a variety of data sources. The Bempedoic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Bempedoic Acid

    Synonyms

    Etc-1002, 738606-46-7, 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid, Nexletol, Esp-55016, Nilemdo

    Cas Number

    738606-46-7

    Unique Ingredient Identifier (UNII)

    1EJ6Z6Q368

    About Bempedoic Acid

    High levels of LDL cholesterol (LDL-C) are a major risk factor for cardiovascular events. Caused by genetic mutations or lifestyle factors, hypercholesterolemia can significantly reduce quality of life and increase the risk of mortality from cardiovascular disease. About 1 in 4 patients, or 15 million Americans with elevated LDL-C, are insufficiently managed with maximally tolerated statin therapy alone, requiring additional treatment for hypercholesterolemia. Bempedoic acid is first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor used once a day for reducing LDL cholesterol levels in statin-refractory patients. It was developed by Esperion Therapeutics Inc. and approved by the FDA on February 21, 2020. A combination product of bempedoic acid and [ezetimibe] was approved on February 26, 2020 for increased control of LDL cholesterol levels in patients experiencing refractory elevations despite previous statin treatment.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- Manufacturers

    A Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl-, including repackagers and relabelers. The FDA regulates Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- Suppliers

    A Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- supplier is an individual or a company that provides Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- active pharmaceutical ingredient (API) or Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- finished formulations upon request. The Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- suppliers may include Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- API manufacturers, exporters, distributors and traders.

    click here to find a list of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- USDMF

    A Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- active pharmaceutical ingredient (API) in detail. Different forms of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- DMFs exist exist since differing nations have different regulations, such as Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- DMF submitted to regulatory agencies in the US is known as a USDMF. Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- USDMF includes data on Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl-'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- suppliers with USDMF on PharmaCompass.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- WC

    A Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- written confirmation (Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- WC) is an official document issued by a regulatory agency to a Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- manufacturer, verifying that the manufacturing facility of a Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- APIs or Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- finished pharmaceutical products to another nation, regulatory agencies frequently require a Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- WC (written confirmation) as part of the regulatory process.

    click here to find a list of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- suppliers with Written Confirmation (WC) on PharmaCompass.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- suppliers with NDC on PharmaCompass.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- GMP

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- GMP manufacturer or Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- GMP API supplier for your needs.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- CoA

    A Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- CoA (Certificate of Analysis) is a formal document that attests to Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl-'s compliance with Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- specifications and serves as a tool for batch-level quality control.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- CoA mostly includes findings from lab analyses of a specific batch. For each Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- may be tested according to a variety of international standards, such as European Pharmacopoeia (Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- EP), Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pentadecanedioic acid, 8-hydroxy-2,2,14,14-tetramethyl- USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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