Bempedoic Acid API
CAS Number: 738606-46-7
About Bempedoic Acid API
Therapeutic Category
Cardiovascular
API Technology
Synthetic
Dose Form
Oral Solids
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.
Dr. Reddy's Expertise
Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Bempedoic Acid API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.
Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Bempedoic Acid API is the outcome of the extensive expertise in R&D, IP, and Regulatory.
A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.
Related Resources
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 acid
- Fixed-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).
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Disclaimer
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.
FAQs
- 180 mg tablet of bempedoic acid
- Fixed-dose combination of 180 mg bempedoic acid and 10 mg ezetimibe.
It is used to reduce LDL cholesterol levels in statin-refractory patients
First-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor
We offer anhydrous non-solvated crystalline form
Meet with our product experts in one-on-one virtual sessions at https://api.drreddys.com/meet-api-experts or Write to us at api@drreddys.com.
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