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BEMPEDOIC ACID
CAS NO.: 738606-46-7
Chemical Formula: C19H36O5
Molecular Weight: 344.5000
DMF&GMP status: Please contact us for more details.
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) inhbitor and a prodrug.

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.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
BEMPEDOIC ACIDTABLET;ORAL180MGNEXLETOLESPERION THERAPEUTICS INC
BEMPEDOIC ACID;EZETIMIBETABLET;ORAL180MG;10MGNEXLIZETESPERION THERAPEUTICS INC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
733579912/03/2025DS
849730112/23/2023U-2747
900004112/23/2023U-2747
962415212/23/2023U-2748
1011888112/23/2023U-2747
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 02/21/2025