MedPath

Obicetrapib

Generic Name
Obicetrapib
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C32H31F9N4O5
CAS Number
866399-87-3
Unique Ingredient Identifier
8O74K609HN
Background

Obicetrapib is under investigation in clinical trial NCT02241772 (A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)).

Associated Conditions
-
Associated Therapies
-
statnews.com
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Uniqure gets FDA OK to seek accelerated approval

New Amsterdam Pharma's CETP inhibitor succeeded in Phase 3 trials, GSK partnered with Relation for fibrotic disease and osteoarthritis drugs, Cardiff Oncology's CRDF-004 showed tumor shrinkage in metastatic colon cancer patients, and Cure Ventures launched Tasca Therapeutics with $52 million for cancer therapies. GSK's Blenrep showed improved survival in multiple myeloma patients, J&J's Darzalex may prevent myeloma in high-risk patients, and Uniqure received FDA approval to seek accelerated approval for Huntington's disease gene therapy.
biospace.com
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NewAmsterdam Pharma Announces Positive Topline Data from Pivotal Phase 3

NewAmsterdam Pharma announced positive Phase 3 BROADWAY trial results for obicetrapib, showing a 33% LDL-C reduction vs. placebo at day 84 (p<0.0001) and a 21% reduction in major adverse cardiovascular events at one year. Obicetrapib was well-tolerated with safety comparable to placebo.
investing.com
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NewAmsterdam reports positive Phase 3 trial results for CVD drug

NewAmsterdam Pharma announced positive Phase 3 BROADWAY trial results for obicetrapib, showing a 33% reduction in LDL-C levels and a 21% reduction in MACE. The drug's safety profile was comparable to placebo. The company plans to discuss regulatory filings in 2025 and present detailed data at a medical conference.

NewAmsterdam Pharma Says Main Goal In Phase 3 BROADWAY Study Achieved; Stock Up In Pre-market

NewAmsterdam Pharma announced positive Phase 3 BROADWAY study results for obicetrapib in treating ASCVD and HeFH, achieving a 33% LDL-C reduction. The drug was well-tolerated, leading to a >50% stock increase pre-market.
medpagetoday.com
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Hunting & Heart Attacks; Cardiologist's Whistleblower Suit; Algorithm Predicts Death

Hunters at risk for heart attack/stroke due to physical exertion and colder temperatures. Positive results for sotatercept in pulmonary arterial hypertension. Fixed-dose combination of obicetrapib and ezetimibe nearly halved LDL cholesterol in statin-resistant patients. TAVR tradeoffs in permanent pacemaker rates and patient-prosthesis mismatch. Better outcomes with Sapien 3 Ultra Resilia TAVR valve. Michigan cardiologist sues for whistleblower retaliation. Machine learning algorithm RF-SLAM predicts mortality and heart failure hospitalization. Dapagliflozin reduces new-onset diabetes in cardiovascular/kidney disease patients. SGLT2 inhibitors improve outcomes in hypertrophic cardiomyopathy with diabetes. GLP-1 receptor agonists show kidney and cardiovascular benefits. Cilostazol reduces in-stent restenosis risk. Bartonella quintana infection risk in solid-organ transplant recipients. Donor-specific antibodies and allograft dysfunction linked to poor prognosis in heart transplant recipients. Regenerative capacity of human cardiomyocytes minimal in heart failure unless on left ventricle support device therapy.

New Amsterdam sees success in Phase III cardiovascular disease trial

New Amsterdam's Phase III TANDEM trial met co-primary endpoints, showing a 48.6% reduction in LDL-C with obicetrapib-ezetimibe combination, supporting regulatory filings for HeFH and ASCVD patients.
finance.yahoo.com
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NewAmsterdam Pharma Reports Promising Phase 3 Trial Results

NewAmsterdam Pharma announces promising Phase 3 TANDEM trial results, showing a fixed-dose combination of obicetrapib and ezetimibe significantly reduces LDL-C levels by 50% and over 70% of patients achieved LDL-C levels below 55 mg/dL, well-tolerated and supporting global regulatory filings.
bioworld.com
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Newamsterdam's obicetrapib combo nails phase III LDL-C endpoints

Newamsterdam Pharma’s phase III study of CETP inhibitor obicetrapib plus ezetimibe shows robust LDL-C reduction, though shares drop 15.5% due to lower-than-expected findings.
biospace.com
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NewAmsterdam Pharma Announces Positive Topline Data from Pivotal Phase 3 TANDEM

NewAmsterdam Pharma announced positive Phase 3 TANDEM trial results, showing obicetrapib and ezetimibe fixed-dose combo significantly reduced LDL-C by 48.6% vs. placebo at day 84, supporting global regulatory filings.
yahoo.com
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Phase III BROOKLYN trial – safety and efficacy of obicetrapib in HeFH patients

Phase III BROOKLYN trial results presented at AHA 2024 show obicetrapib significantly reduces LDL cholesterol in HeFH patients, with 34% achieving >50% reduction. Obicetrapib also lowers Lp(a) by 54.3% and raises HDL cholesterol, with no serious adverse events reported.
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