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About Bempedoic Acid API

Product
  • Therapeutic CategoryCardiovascular

  • CAS Number

    738606-46-7

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    Brazil DMF

Mechanism of Action

Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Bempedoic acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively. ACSVL1 is expressed primarily in the liver. Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors.

Indication

NEXLETOL is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

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Related Resources

Tech sheet: Dr. Reddy's Bempedoic Acid API Offerings

Tech sheet: Dr. Reddy's Bempedoic Acid API Offerings

Bempedoic acid (Brand: Nexletol, Innovator: Esperion) is an essentially new, oral treatment option approved for patients needing further LDL-C lowering beyond maximally tolerated statin therapy. Bempedoic acid is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients.Bempedoic acid acts by inhibiting ATP citrate lyase. It is a prodrug activated only in the liver, thus preventing the muscle related adverse events seen with statins.Esperion’s product was approved in the US in February 2020 and Europe in April 2020. It has also inked a commercialization deal with Otsuka in Japan and entered into an exclusive licensing agreement with Daiichi Sankyo for South Korea, Brazil, Taiwan, Hong Kong, Macao, Thailand, Vietnam, Myanmar, and Cambodia.Bempedoic acid is available in two approved formulations:180 mg tablet of bempedoic acidFixed-dose combination of 180 mg bempedoic acid and 10 mg ezetimibe.Dr. Reddy’s is well-positioned to meet the global demand for bempedoic acid. We have established solid strategic sourcing, logistics partnerships and work closely with our customers to successfully manage the capacities of our manufacturing units ahead of launches.Are you interested in adding bempedoic acid to your portfolio? Please get in touch with us at api@drreddys.com. To know more about our offering and pipeline products, Log in to our customer service portal XCEED (https://api.drreddys.com/customer_portal/login).
Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.