Drugs / Obicetrapib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | hyperlipidemia, familial combined, LPL related | 2025-09-02 | “EMA has validated the Marketing Authorization Application (MAA) for obicetrapib, a selective cholesteryl ester transfer protein (CETP) inhibitor, and obicetrapib/ezetimibe...” menarini.com ↗ “Marketing Authorization Applications for obicetrapib and the fixed dose combination were accepted for review by the European Medicines Agency (“EMA”)” newamsterdampharma.com ↗ “today announced that EMA has validated the Marketing Authorization Application (MAA) for obicetrapib” menarini.com ↗ |
Trials 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06250205 | Feb → Apr 2024 | — | NewAmsterdam Pharma | Completed | No outcome recorded |
| Phase 1 | NCT06050291 | Jan → Apr 2024 | — | NewAmsterdam Pharma | Completed | No outcome recorded |
| Phase 1 | NCT05972278 | Dec 2023 → Sep 2024 overdue | — | NewAmsterdam Pharma | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06048302 | Nov 2023 → Mar 2024 | — | NewAmsterdam Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02408055 | Jun → Aug 2015 | hyperlipidemia | Xention Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02241759 | Aug → Nov 2014 | hyperlipidemia | Xention Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02124954 | May → Jul 2014 | — | Xention Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01879020 | Aug 2009 → Jun 2010 | hyperlipidemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01878474 | Mar 2008 → Jun 2009 | hyperlipidemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02241772 | Sep 2014 → Jan 2015 | lipoprotein, variant of beta | Xention Ltd | Completed | No outcome recorded |
| Phase 29 trials · 5 met primary | ||||||
| Phase 2 | NCT07794670 | Sep 2026 → Sep 2028 expected | Alzheimer disease | NewAmsterdam Pharma | Recruiting | No outcome recorded |
| Phase 2 | NCT06982508 | Sep 2025 → Sep 2026 overdue | — | NewAmsterdam Pharma | Recruiting | No outcome recorded |
| Phase 2 | NCT06496243 | Dec 2024 → Nov 2026 expected | hyperlipidemia | NewAmsterdam Pharma | Recruiting | No outcome recorded |
| Phase 2 | NCT05421078 | Jun 2022 → Mar 2023 | hyperlipidemia | NewAmsterdam Pharma | Completed | Met primary |
| Phase 2 | NCT05266586 | Mar → Aug 2022 | hyperlipidemia | NewAmsterdam Pharma | Completed | Met primary |
| Phase 2 | NCT05161715 | Jan 2022 → May 2023 | Alzheimer disease | NewAmsterdam Pharma | Completed | No outcome recorded |
| Phase 2 | NCT04770389 | Feb → May 2021 | hyperlipidemia, hyperlipoproteinemia | NewAmsterdam Pharma | Completed | Met primary |
| Phase 2 | NCT04753606 | Feb → May 2021 | hyperlipidemia, hyperlipoproteinemia, low density lipoprotein cholesterol, mild elevation of | NewAmsterdam Pharma | Completed | Met primary |
| Phase 2 | NCT01970215 | Aug 2013 → Jul 2014 | hyperlipidemia | Xention Ltd | Completed | Met primary |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT07614958 | May 2026 → Jan 2027 expected | hyperlipidemia, combined, 2 | A. Menarini International Licensing S.A. | Recruiting | No outcome recorded |
| Phase 3 | NCT07219602 | Dec 2025 → Mar 2028 expected | hyperlipidemia, metabolic syndrome X, type 2 diabetes mellitus | NewAmsterdam Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06305559 | May 2024 → Nov 2027 expected | atherosclerosis, coronary artery disorder, hyperlipidemia | NewAmsterdam Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06005597 | Mar → Sep 2024 | atherosclerotic cardiovascular disease, familial hypercholesterolemia | NewAmsterdam Pharma | Completed | Met primary |
| Phase 3 | NCT05425745 | Jul 2022 → May 2024 | familial hypercholesterolemia, low density lipoprotein cholesterol, mild elevation of | NewAmsterdam Pharma | Completed | Met primary |
| Phase 3 | NCT05202509 | Feb 2022 → Nov 2026 expected | atherosclerotic cardiovascular disease | NewAmsterdam Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05142722 | Dec 2021 → Sep 2024 | atherosclerotic cardiovascular disease, familial hypercholesterolemia | NewAmsterdam Pharma | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT06547359 Comparator | Oct → Nov 2024 | — | NewAmsterdam Pharma | Completed | No outcome recorded |
| Phase 1 | NCT06081166 Comparator | Nov → Dec 2023 | — | NewAmsterdam Pharma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
All press releases naming this drug 9 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | obicetrapib | “Participants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fed condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10...” NCT06050291 ↗21“Patients were randomly assigned to one of nine groups using various combinations of the CETP inhibitor TA-8995 (obicetrapib), statin therapy, and placebo.” PMID 36307922 ↗ Feb 2023 |
| Known as | AMG-899 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3785197 ↗ |
| Known as | CASA | ChEMBL registry synonym — accepted as the source's own label CHEMBL3785197 ↗ |
| Known as | DEZ-001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3785197 ↗ |
| Known as | OBI | “obicetrapib (OBI) compared to bempedoic acid (BPA)” NCT07614958 ↗ |
| Known as | OBICETRAPIB CALCIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3785197 ↗ |
| Known as | TA-8995 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01970215 ↗ |
| Known as | TA-8995 CALCIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3785197 ↗ |
| Action | Inhibit | “TA-8995 is a potent inhibitor of cholesteryl ester transfer protein (CETP)” PMID 27678430 ↗ Jun 2016 |
| Modality | Small molecule | — CHEMBL3785197 ↗ |
| Route | Oral | “Single oral dose of 150mg TA-8995” NCT02241759 ↗ |
| Target | CETP | “the cholesteryl ester transfer protein (CETP) inhibitor drug obicetrapib” PMID 35953719 ↗ Aug 2022 |