ATORVALIQ (atorvastatin calcium)
Atorvaliq is an HMG-CoA reductase inhibitor (statin) indicated to reduce the risk of myocardial infarction, stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) or type 2 diabetes, as well as those with clinically evident CHD (where it also reduces the risk of hospitalization for congestive heart failure). It is used as an adjunct to diet to lower LDL-C in adults with primary hyperlipidemia and in adults and pediatric patients (10 years and older) with heterozygous or homozygous familial hypercholesterolemia. Additionally, it is indicated for adults with hypertriglyceridemia and primary dysbetalipoproteinemia.
How ATORVALIQ Works
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-
Details
- Status
- Prescription
- First Approved
- 2023-02-01
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
ATORVALIQ Approval History
What ATORVALIQ Treats
11 indicationsATORVALIQ is approved for 11 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myocardial Infarction
- Stroke
- Angina
- Coronary Heart Disease
- Type 2 Diabetes
- Congestive Heart Failure
- Primary Hyperlipidemia
- Heterozygous Familial Hypercholesterolemia
ATORVALIQ 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 ATORVALIQ's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ATORVALIQ treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ATORVALIQ
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.
ATORVALIQ FDA Label Details
Indications & Usage
FDA Label (PDF)ATORVALIQ is indicated for the treatment of Myocardial Infarction; Stroke; Angina; Coronary Heart Disease; Type 2 Diabetes; Congestive Heart Failure; Primary Hyperlipidemia; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia; Primary Dysbetalipoproteinemia; Hypertriglyceridemia.
ATORVALIQ Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for ATORVALIQ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 6 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.