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Details:
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.
Lead Product(s): Obicetrapib,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 12, 2024
Details:
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.
Lead Product(s): Rosuvastatin,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Rosuzet
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2023
Details:
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.
Lead Product(s): Obicetrapib,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2023
Details:
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.
Lead Product(s): Obicetrapib,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Details:
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.
Lead Product(s): Obicetrapib,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2022
Details:
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.
Lead Product(s): Inclisiran,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2021
Details:
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.
Lead Product(s): Bempedoic Acid,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Nexlizet
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England.
Lead Product(s): Inclisiran,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 01, 2021
Details:
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.
Lead Product(s): Bempedoic Acid,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Nexlizet
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: $1,130.0 million Upfront Cash: $30.0 million
Deal Type: Partnership April 26, 2021
Details:
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.
Lead Product(s): Bempedoic Acid,Ezetimibe,Atorvastatin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Nexletol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2021
Details:
Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies.
Lead Product(s): Bempedoic Acid,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Nustendi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2020
Details:
The collaboration advances the commitment of both companies to provide cost-effective, oral, once-daily, non-statin LDL-cholesterol lowering medicines for hypercholesterolemia patients in Japan.
Lead Product(s): Bempedoic Acid,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: $510.0 million Upfront Cash: $60.0 million
Deal Type: Collaboration April 20, 2020
Details:
NUSTENDI is approved for patients who require additional Ldl-Cholesterol lowering on a background statin, other lipid-lowering therapies, or considered statin intolerant.
Lead Product(s): Bempedoic Acid,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2020
Details:
The program evaluated the safety, tolerability and LDL-C lowering efficacy of NEXLETOL and NEXLIZET in patients with hypercholesterolemia.
Lead Product(s): Bempedoic Acid,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2020
Details:
Positive CHMP opinions are based on a global clinical trial programme demonstrating consistent LDL-C lowering across a range of patient populations.
Lead Product(s): Bempedoic Acid,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2020
Details:
The CHMP recommended granting the bempedoic acid tablet marketing authorisation for the treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia.
Lead Product(s): Bempedoic Acid,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2020
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