TheraRadar
Data updated: May 26, 2026

ATORVASTATIN CALCIUM

Trial Activity: Declining 24 active trials
Cardiovascular Approved 2011-11-30

Atorvastatin calcium is an HMG-CoA reductase inhibitor indicated to reduce the risk of myocardial infarction, stroke, revascularization procedures, and angina in adults with or without clinically evident coronary heart disease, including those with type 2 diabetes. It is used as an adjunct to diet to reduce elevated LDL-C, total cholesterol, and triglycerides in adults with primary hyperlipidemia, hypertriglyceridemia, and primary dysbetalipoproteinemia. Additionally, it is indicated for adults and pediatric patients (10 years and older) with heterozygous or homozygous familial hypercholesterolemia.

Source: FDA Label • LANNETT CO INC
Jump to: Indications Approvals Trials Competitors Safety Patents

How ATORVASTATIN CALCIUM Works

Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols including cholesterol. By inhibiting hepatic cholesterol synthesis, atorvastatin triggers an upregulation of hepatic LDL receptors on the cell surface, which enhances the uptake and catabolism of LDL. This results in a reduction of circulating LDL particles and total plasma cholesterol.

Source: FDA Label

Development Insights

Sanofi conducting 12 trials (5%)
241 indications explored (Broad Platform)
→ hypercholesterolemia (36 trials)
→ healthy (19 trials)
→ hyperlipidemia (14 trials)
29
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Prescription
First Approved
2011-11-30
Routes
ORAL
Dosage Forms
TABLET

Companies

LANNETT CO INC Dr. Reddy's ALKEM LABS LTD HETERO LABS LTD V LAURUS MANKIND PHARMA Teva MICRO LABS LTD INDIA INVAGEN PHARMS MACLEODS PHARMS LTD SHANDONG XINHUA MSN CADILA PHARMS LTD LEPU PHARM Sun Pharma Apotex SCIEGEN PHARMS GRAVITI PHARMS STRIDES PHARMA Viatris ZYDUS PHARMS ACCORD HLTHCARE Lupin BIOCON PHARMA CHARTWELL RX PERRIGO R AND D UMEDICA Aurobindo Pharma
Active Ingredient: ATORVASTATIN CALCIUM

ATORVASTATIN CALCIUM Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
669 FDA actions from 2011 to 2026
Apr 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Mfg · Manufacturing (CMC)
Dec 2025 SUPPL
Label · Labeling

What ATORVASTATIN CALCIUM Treats

29 FDA approvals

Originally approved for its first indication in 2011 . Covers 29 distinct patient populations.

  • Other (29)

ATORVASTATIN CALCIUM Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

10

Same target(s), different indications — where else is this mechanism being explored?

ZYPITAMAG
MEDICURE
2017 1 indic.
PITAVASTATIN CALCIUM
ZYDUS PHARMS
2016 2 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

📋

Clinical Trial Registry

266 trials
Trial Sponsor ID Phase Status Title
NCT07534592 D7260C00028 Ph 1 recruiting A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants
NCT07530289 8507-018 MK-8507-018 Ph 1 recruiting A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018)
NCT02850081 STANCE results posted AAAM2407 Ph 3 terminated Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes
NCT03819101 PEACE-4 2017-004639-35 2017/2601 Ph 3 recruiting Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
NCT03560882 IIT-2018-p53Atorva Ph 1 active not recruiting A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies
NCT03753555 INSIST-HRMRI k（2018）44 Ph 4 recruiting The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques
NCT06312748 CARB-019-20S 138675 Ph 1 recruiting Novel Approaches for Improving Vascular Function in Veterans With HFpEF
NCT06372925 V-ACCELERATE CKJX839A1CN04 CKJX839A1CN04 Ph 4 recruiting Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
NCT05483010 202211020 Ph 2 recruiting Statins in Patients With Clonal Cytopenia of Undetermined Significance (CCUS) and Myelodysplastic Syndromes (MDS)
NCT07502001 HDM1005-104 Ph 1 not yet recruiting Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin
NCT05488067 ATO-ALGS-XAN Ph 4 completed Atorvastatin Therapy on Xanthoma in Alagille Syndrome
NCT07497776 NIKDU-Bangla Ph 4 completed Atorvastatin Therapy in the Treatment of Dyslipidemia in Children With Steroid Sensitive Nephrotic Syndrome
NCT02432534 15-AOI-01 Ph 2 completed Atorvastatin in Active Vitiligo
NCT07474649 DSE-BMP-0005-CIS-MA 2025-524625-41 Ph 3 not yet recruiting A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
NCT07045142 WU202505STA Ph 3 recruiting Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
NCT06157099 STUDY00025369 NCI-2023-03875 Ph 2 active not recruiting Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma
NCT07462715 SABS H40420 2039822 Ph 4 not yet recruiting Statins Against Bushfire Smoke
NCT04915183 210002 21-DC-0002 Ph 2 recruiting Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
NCT07268625 DSE-BMP-0003-CIS-MA 2024-519851-27-00 Ph 1 completed Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin
NCT07235189 DSE-BMP-0001-CIS-MA 2024-519849-29-00 Ph 1 completed A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin
NCT04767984 NCI 20-02-02 P30CA060553, UG1CA242643 Ph 2 active not recruiting Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
NCT04679376 STAT NASH 22-007824 Ph 2 active not recruiting Statins for the Treatment of NASH
NCT06024096 results posted STUDY00006239 2025P010158 Ph 4 completed Systems Biological Assessment of Statin Effect on Vaccine Responses
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
NCT07012629 EURO-CBI 2025-521452-30-01 2025-521452-30-01 Ph 3 recruiting A EUROpean Randomized Study on Blood-thinners and Cholesterol-lowering Treatments to Prevent Future Vascular Events in People With Covert Brain Infarcts (CBI)
NCT07042165 BASTA EU trial no. 2025-521856-47-00 Ph 4 recruiting Treatment of Bile Acid Diarrhoea With Atorvastatin
NCT06948747 D7260C00017 Ph 1 completed A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants
NCT02603328 AT CASH EPOC results posted IRB18-0445 Ph 1, Ph 2 completed Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial
NCT06567327 C3421086 NCT06567327 Ph 1 completed A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese
NCT05796973 MOVES 2019-001982-34 Ph 3 recruiting Measuring Oncological Value of Exercise and Statin
NCT04972396 ALT-801-103 Pemvidutide, ALT-801 Ph 1 completed Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
NCT06723691 HRS9531-107 Ph 1 completed Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects
NCT06081166 TA-8995-11 Ph 1 completed A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin
NCT02943590 results posted 16-440 Ph 2 completed STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
NCT06289504 NN9838-4694 U1111-1295-4056 Ph 1 completed A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
NCT04904536 STRONGER X21-0113 Ph 3 active not recruiting Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy
NCT06750783 Xuezhikang 2.0 20240725 Ph 4 recruiting The Effects of Xuezhikang and Atorvastatin on Lipid in Patients With Dyslipidemia and Prediabetes
NCT04388501 CR108776 2019-004640-29, 70033093THR1002 Ph 1 completed A Study Evaluating Drug Drug Interaction Between Milvexian and Atorvastatin in Healthy Participants
NCT04824911 SATBRAD 202001386A3 Ph 2 completed Statin and Dual Antiplatelet Therapy to Prevent Early Neurological Deterioration in Branch Atheromatous Disease
NCT06191991 ALG-055009-302 Ph 1 completed A Phase 1 Study to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)
NCT05331053 results posted STUDY00009584 Ph 4 terminated MicroRNA Activation of LOX-1 Mechanisms in Endometriosis
NCT06785974 SPIRAL 11670 Ph 4 not yet recruiting Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
NCT03308578 SCAT-OSA 17-005119 R01HL065176 Ph 1, Ph 2 completed Statins and CPAP in Adipose Tissue of OSA
NCT02099123 STAREE NHMRC 1068146 Ph 4 active not recruiting A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)
NCT06699355 0616-024 MK-0616-024 Ph 1 completed A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)
NCT03024684 SHOT 105005 Ph 4 active not recruiting Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment
NCT02740699 results posted 160089 16-H-0089 Ph 4 terminated CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction
NCT03872388 results posted 2018-0550 NCI-2019-00004, 2018-0550 Ph 2 terminated Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy
NCT05464628 ASC42-103 Ph 1 completed Drug Interaction Study of ASC42 With Atorvastatin
NCT06601517 HDM1002-106 Ph 1 not yet recruiting A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.

Showing 50 of 266 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

ATORVASTATIN CALCIUM FDA Label Details

Indications & Usage

Atorvastatin calcium tablets are 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) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein chol...

Looking for the branded version?

LIPITOR

Full clinical data, patents, trials, and competitive landscape for atorvastatin calcium.

See LIPITOR

Data Sources

FDA Approval: ANDA091624 → Label: DailyMed → Trials: ClinicalTrials.gov →

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