Selected approval record (2004-07-23): FDA approved the fixed combination of ezetimibe and simvastatin as Vytorin. Each component had been approved earlier.
Status in this atlas: Selected approval record (2004-07-23): FDA approved the fixed combination of ezetimibe and simvastatin as Vytorin. Each component had been approved earlier. Status source
Combines intestinal cholesterol-absorption inhibition by ezetimibe with HMG-CoA reductase inhibition by activated simvastatin.
Mechanism & side effects: Statins · Ezetimibe(component classes; combination risks can differ)
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
The molecule
Two chemically distinct active ingredients used together. Display the two component structures separately, retaining simvastatin in its administered lactone form.
The parent drug is shown; its glucuronide metabolite is not included. The optional 3D view is a computed PubChem conformer, not an experimentally measured or protein-bound shape.
Chemical structure of simvastatin in its administered lactone form.
Shown: Neutral simvastatin lactone prodrug.
This is simvastatin, not its ring-opened active hydroxy-acid metabolite. The optional 3D view is a computed PubChem conformer, not an experimentally measured or protein-bound shape.
A next milestone is not summarized for this therapy. This does not mean development has ended.
Development history5 selected milestones
Ezetimibe + simvastatin · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.
Publication
Early combination studies published
Short clinical pharmacology studies showed additional LDL-C lowering when ezetimibe was coadministered with simvastatin. These studies tested the two drugs together before approval of a fixed-combination tablet.
Adding ezetimibe to simvastatin did not significantly improve carotid artery wall-thickness progression despite greater LDL-C lowering. This was an imaging outcome, not a cardiovascular-event trial.
Adding ezetimibe to simvastatin reduced the cardiovascular composite after acute coronary syndrome. This supports the combination in that setting, not ezetimibe monotherapy; the trial is plotted on the outcomes page.
