LYPQOZET (atorvastatin calcium)
LYPQOZET (atorvastatin) is indicated to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple cardiovascular risk factors or established coronary heart disease (CHD). It is also used as an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia and in pediatric patients (10 years and older) with heterozygous familial hypercholesterolemia (HeFH). Furthermore, it is indicated for the reduction of LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) and for the treatment of adults with hypertriglyceridemia or primary dysbetalipoproteinemia
How LYPQOZET Works
This medication works by blocking HMG-CoA reductase, the primary enzyme responsible for producing cholesterol in the liver. By inhibiting this process, the drug increases the number of receptors on liver cells that capture and remove LDL cholesterol from the bloodstream. This dual action reduces the overall production and circulation of harmful cholesterol particles.
Details
- Status
- Prescription
- First Approved
- 2017-04-26
- Routes
- ORAL
- Dosage Forms
- TABLET
LYPQOZET Approval History
What LYPQOZET Treats
10 indicationsLYPQOZET is approved for 10 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myocardial Infarction
- Stroke
- Angina
- Type 2 Diabetes
- Congestive Heart Failure
- Primary Hyperlipidemia
- Heterozygous Familial Hypercholesterolemia
- Homozygous Familial Hypercholesterolemia
LYPQOZET Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LYPQOZET's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LYPQOZET treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03753555 INSIST-HRMRI | k（2018）44 | Ph 4 | recruiting | The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques |
| NCT04767984 | NCI 20-02-02 P30CA060553, UG1CA242643 | Ph 2 | active not recruiting | Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis |
| NCT05826912 APT-TBI-01 | APT-TBI-01 | Ph 2 | enrolling by invitation | Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury |
| NCT06081166 | TA-8995-11 | Ph 1 | completed | A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin |
| NCT01665677 results posted | PRO00021090 WVU 011012, 116837-IRG-09-061-01 | Ph 2 | completed | Atorvastatin as GVHD Prophylaxis for Allogeneic Hematopoietic Cell Transplantation |
| NCT05583643 | FWA00025577 | Ph 1 | completed | Clinical & Biochemical Effect of Atorvastatin in Nano Particles Gel in Periodontitis Treatment |
| NCT01527045 results posted | 2546.00 NCI-2011-03828, 2546.00 | Ph 2 | completed | Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies |
| NCT00687271 results posted | 6213-006 2007_514, 2007-003684-41 | Ph 2 | completed | A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006) |
| NCT01050348 IMPRES | 09-004 / WPCI 2009-08 | Ph 4 | completed | To Investigate the Role of Upstream High Dose Statin in STEMI |
| NCT01220973 results posted | 0220090006, 080811 0220090006, NCI-2012-00540 | Ph 2 | completed | Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer |
| NCT01525407 results posted | 2545.00 NCI-2011-03827, 2545.00 | Ph 2 | completed | Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation |
| NCT00637481 | NCI-2009-00859 NCI-2009-00859, CDR0000653466 | Ph 1 | completed | A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LYPQOZET FDA Label Details
Indications & Usage
LYPQOZET is indicated for the treatment of Myocardial Infarction; Stroke; Angina; Type 2 Diabetes; Congestive Heart Failure; Primary Hyperlipidemia; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia; Primary Dysbetalipoproteinemia; Hypertriglyceridemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.