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Monotherapy obicetrapib
Monotherapy obicetrapib is a CETP inhibitor Small molecule drug developed by NewAmsterdam Pharma. It is currently in Phase 3 development for Cardiovascular risk reduction in patients with established coronary heart disease (Phase 3). Also known as: CETP inhibitor.
Obicetrapib inhibits CETP (cholesterol ester transfer protein) to increase HDL cholesterol and reduce LDL cholesterol levels.
Obicetrapib is being studied as a potential treatment for lipidemia, type 2 diabetes, metabolic syndrome, dyslipidemias, and high cholesterol. It is being evaluated in combination with ezetimibe or as a standalone treatment in clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Monotherapy obicetrapib |
|---|---|
| Also known as | CETP inhibitor |
| Sponsor | NewAmsterdam Pharma |
| Drug class | CETP inhibitor |
| Target | CETP (cholesterol ester transfer protein) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
CETP is a protein that transfers cholesterol esters from HDL to apoB-containing lipoproteins, effectively lowering HDL and raising LDL. By blocking CETP, obicetrapib shifts the lipid profile toward higher HDL and lower LDL cholesterol, potentially reducing cardiovascular risk. This mechanism aims to provide additional lipid-lowering benefit beyond statins in patients with established cardiovascular disease.
Approved indications
- Cardiovascular risk reduction in patients with established coronary heart disease (Phase 3)
Common side effects
- Elevated uric acid
- Gout
- Hepatic enzyme elevation
Key clinical trials
- A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (PHASE3)
- Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies (PHASE3)
- Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy (PHASE2)
- Randomized Study of Obicetrapib in Combination With Ezetimibe (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Monotherapy obicetrapib CI brief — competitive landscape report
- Monotherapy obicetrapib updates RSS · CI watch RSS
- NewAmsterdam Pharma portfolio CI
Frequently asked questions about Monotherapy obicetrapib
What is Monotherapy obicetrapib?
How does Monotherapy obicetrapib work?
What is Monotherapy obicetrapib used for?
Who makes Monotherapy obicetrapib?
Is Monotherapy obicetrapib also known as anything else?
What drug class is Monotherapy obicetrapib in?
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What does Monotherapy obicetrapib target?
Related
- Drug class: All CETP inhibitor drugs
- Target: All drugs targeting CETP (cholesterol ester transfer protein)
- Manufacturer: NewAmsterdam Pharma — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Cardiovascular risk reduction in patients with established coronary heart disease (Phase 3)
- Also known as: CETP inhibitor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing