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ezetimibe/simvastatin 10/40 — Competitive Intelligence Brief
phase 3
Combination lipid-lowering agent (ezetimibe + statin)
NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin)
Cardiovascular
Small molecule
Live · refreshed every 30 min
Target snapshot
ezetimibe/simvastatin 10/40 (ezetimibe/simvastatin 10/40) — Organon and Co. Ezetimibe/simvastatin reduces blood cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin).
Comparator set (5 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| ezetimibe/simvastatin 10/40 TARGET | ezetimibe/simvastatin 10/40 | Organon and Co | phase 3 | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| Ezetimibe + Simvastatin | Ezetimibe + Simvastatin | Organon and Co | marketed | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | University of Texas Southwestern Medical Center | marketed | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| EZE/simvastatin | EZE/simvastatin | Azienda Ospedaliero Universitaria di Sassari | marketed | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| Comparator: Placebo to ezetimibe/simvastatin | Comparator: Placebo to ezetimibe/simvastatin | Organon and Co | phase 3 | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| Comparator: ezetimibe and simvastatin | Comparator: ezetimibe and simvastatin | Organon and Co | phase 3 | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe) and HMG-CoA reductase (simvastatin) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Combination lipid-lowering agent (ezetimibe + statin) class)
- Organon and Co · 4 drugs in this class
- Azienda Ospedaliero Universitaria di Sassari · 1 drug in this class
- University of Texas Southwestern Medical Center · 1 drug in this class
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Cite this brief
Drug Landscape (2026). ezetimibe/simvastatin 10/40 — Competitive Intelligence Brief. https://druglandscape.com/ci/ezetimibe-simvastatin-10-40. Accessed 2026-06-10.
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