LIPITOR (atorvastatin calcium)
Lipitor is indicated to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD), including those with type 2 diabetes, regardless of whether CHD is clinically evident. It is also indicated to reduce the risk of hospitalization for congestive heart failure. As an adjunct to diet, it is used to treat primary hyperlipidemia, hypertriglyceridemia (Type IV), and primary dysbetalipoproteinemia (Type III). Furthermore, it is indicated for adults and pediatric patients (10 years and older) with heterozygous and homozygous familial hypercholesterolemia.
How LIPITOR Works
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-12-17
- Routes
- ORAL
- Dosage Forms
- TABLET
LIPITOR Approval History
What LIPITOR Treats
11 indicationsLIPITOR is approved for 11 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myocardial Infarction
- Stroke
- Angina
- Type 2 Diabetes
- Coronary Heart Disease
- Congestive Heart Failure
- Primary Hyperlipidemia
- Heterozygous Familial Hypercholesterolemia
LIPITOR 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 LIPITOR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LIPITOR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LIPITOR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 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 |
| NCT01710007 results posted | QCR10022 | Ph 3 | completed | Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia |
| 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 |
| NCT00844376 results posted | A2581164 | Ph 4 | completed | Bioavailability Study for New Atorvastatin Formulation |
| NCT00777517 | A2581174 | Ph 1 | completed | Bioequivalence Study On Pediatric Appropriate Formulation |
| 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.
LIPITOR FDA Label Details
Indications & Usage
FDA Label (PDF)LIPITOR is indicated for the treatment of Myocardial Infarction; Stroke; Angina; Type 2 Diabetes; Coronary Heart Disease; 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment