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Comparator: Placebo to ezetimibe/simvastatin — Competitive Intelligence Brief

Comparator: Placebo to ezetimibe/simvastatin (Comparator: Placebo to ezetimibe/simvastatin) competitive landscape: 5 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Combination lipid-lowering agent (ezetimibe + statin). Area: Cardiovascular.

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

Comparator: Placebo to ezetimibe/simvastatin (Comparator: Placebo to ezetimibe/simvastatin) — Organon and Co. Ezetimibe/simvastatin is a combination that reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin).

Comparator set (5 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Comparator: Placebo to ezetimibe/simvastatin TARGET Comparator: Placebo to ezetimibe/simvastatin Organon and Co phase 3 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)
Ezetimibe + Simvastatin Ezetimibe + Simvastatin Organon and Co 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)
ezetimibe/simvastatin 10/40 ezetimibe/simvastatin 10/40 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)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Combination lipid-lowering agent (ezetimibe + statin) class)

  1. Organon and Co · 4 drugs in this class
  2. Azienda Ospedaliero Universitaria di Sassari · 1 drug in this class
  3. University of Texas Southwestern Medical Center · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Comparator: Placebo to ezetimibe/simvastatin — Competitive Intelligence Brief. https://druglandscape.com/ci/comparator-placebo-to-ezetimibe-simvastatin. Accessed 2026-05-16.

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