[{"orgOrder":0,"company":"Daiichi Sankyo","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CHMP issues positive opinions for both bempedoic acid and the bempedoic acid \/ ezetimibe fixed dose combination tablet as treatments for hypercholesterolaemia","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Esperion Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Esperion Announces Positive CHMP Opinion for the Marketing Authorisation Application for Bempedoic Acid for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia","therapeuticArea":"Cardiology\/Vascular 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Diseases","graph2":"Approved"},{"orgOrder":0,"company":"NHS England","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"World-first Agreement Between Novartis and the NHS Enables Broad and Rapid Access to First-in-Class Cholesterol-Lowering Medicine Leqvio\u00ae","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Esperion Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NEXLETOL\u00ae (Bempedoic Acid) Tablet, Ezetimibe and Atorvastatin Combination Lowered Bad Cholesterol by 60.5% vs. Placebo in Phase 2 Study","therapeuticArea":"Cardiology\/Vascular 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in People who Are Overweight or Obese","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"NewAmsterdam Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NewAmsterdam Pharma Doses First Patient in Phase 2 Trial of Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase II","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"NewAmsterdam Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NewAmsterdam Pharma Announces Initiation of Phase 2 Dose-Finding Study Evaluating Obicetrapib in Japanese Patients","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase II","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"NewAmsterdam Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NewAmsterdam Announces Positive Results from ROSE2, Phase 2 Trial Evaluating Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase II","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Hanmi Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Hanmi Pharmaceutical's Combination Drug for Dyslipidemia Treatment, 'Rosuzet': Confirmed Non-inferiority Efficacy and Safety Compared to Monotherapy in 'The Lancet' & 'European Heart Journal'","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"NewAmsterdam Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and\/or ASCVD","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Ezetimibe
NewAmsterdam TA-8995 (obicetrapib), CETP inhibitor, in combination with Ezetimibe. It is being evaluated in Phase III clinical trial studies with patients for the treatment of Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease.
Rosuzet is a combination of rosuvastatin is an inhibitor of HMG CoA-reductase, the rate-limiting enzyme that converts the precursor of cholesterol and ezetimibe, a sterol transporter, NPC1L1, which is involved in the intestinal uptake of cholesterol.
TA-8995 (obicetrapib) is a next-generation, non statin, oral once-daily, low-dose CETP inhibitor having the potential for lowering LDL-C, if approved. It is currently being investigated in combination with ezetimibe as an adjunct to high-intensity statin therapy.
Obicetrapib (TA-8995) is an oral, low-dose and once-daily CETP inhibitor, initially in development for patients at high risk for cardiovascular disease as an adjunct to maximally tolerated statin therapy, both as a monotherapy and in a fixed-dose combination with ezetimibe.
ROSE2 study evaluates obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor, in combination with ezetimibe, a cholesterol absorption inhibitor, in patients who are currently receiving high-intensity statin therapy.
Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.
Bempedoic acid is 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.
Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England.
The agreement combines Esperion Therapeutics’ first-in-class ATP Citrate Lyase (ACL) inhibitor, bempedoic acid, with Daiichi Sankyo’s commercial capabilities, as well as synergies with their existing portfolio of cardiovascular medicines.
The aim of this Phase 2 study was to evaluate LDL-C lowering when NEXLETOL was initiated together with ezetimibe (10 mg) and atorvastatin (20 mg), as compared with placebo.
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