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atorvastatin

Generic: ATORVASTATIN CALCIUM·Brand: ATORVALIQ, ATORVASTATIN CALCIUM, Atorvaliq, Caduet, LIPITOR, Lipitor

atorvastatin: developed by 2 companies · 11 clinical trials tracked · 5 FDA decisions.

atorvastatin evidence translation

What we can confirm

5 FDA records · 11 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about atorvastatin, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence5 indications · 7 study sponsors
Development Pipeline (2)
Clinical Trials (11)showing 10 most recent

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of UBT251 on the Pharmacokinetics of Single Oral Doses of Metformin, Warfarin, Atorvastatin, and Digoxin in Overweight or Obese Participants.

NCT07785934·Phase 1
Recruiting

Primary endpoint: Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞)

Interventionalopen48 targetStarted 2026-05Completion 2026-121 site · ChinaThe United Bio-Technology (Hengqin) Co., Ltd.

An Open-label, Fixed-sequence Study to Assess the Effect of Elecoglipron on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Participants

NCT07534592·Phase 1·AZN
Active, not recruiting

Primary endpoint: Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin

Interventionalopen48 targetStarted 2026-04Completion 2026-082 sites · United StatesAstraZeneca

A Multi-Center, Randomized, Open-label, Parallel, Controlled Phase Ⅳ Clinical Trial to Evaluate the Effect of Inclisiran on Coronary Atherosclerotic Plaque in Patients With Acute Myocardial Infarction and Elevated Low-density Lipoprotein Cholesterol

NCT06372925·Phase 4·NVS
Active, not recruiting

Primary endpoint: Change in percent atheroma volume (PAV)

InterventionalRandomizedsingle318 enrolledStarted 2024-07Completion 2027-0119 sites · ChinaNovartis Pharmaceuticals

EpisodicStatinMig. A Multicentre, Triple Blind, Placebo Controlled, Parallel Group Study of Atorvastatin in Episodic Migraine

NCT06248671·Phase 2·VALN
Recruiting

Primary endpoint: Number of migraine days

InterventionalRandomizedtriple450 targetStarted 2024-05Completion 2029-026 sites · NorwaySt. Olavs Hospital

An Open-label, One-sequence Cross-over, Single-centre Trial, Investigating the Influence of CagriSema on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Atorvastatin in Participants With Overweight or Obesity

NCT06289504·Phase 1·NVO
Completed

Primary endpoint: AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state

InterventionalRandomizedopen34 enrolledStarted 2024-02Completion 2024-111 site · CanadaNovo Nordisk A/S

A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects

NCT06081166·Phase 1·NAMS
Completed

Primary endpoint: Measure atorvastatin/rosuvastatin levels in the blood

Interventionalopen74 enrolledStarted 2023-11Completion 2024-011 site · CanadaNewAmsterdam Pharma

Vascular Endothelial Dysfunction in Sleep Apnea

NCT05289063·Phase 1·CRNX
Recruiting

Primary endpoint: Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy

InterventionalRandomizedquadruple110 targetStarted 2022-10Completion 2027-021 site · United StatesColumbia University

A Pilot Study of Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy

NCT05342974·Early Phase 1
Completed

Primary endpoint: Interference in pregnancy progress

Interventionalopen9 enrolledStarted 2022-04Completion 2025-011 site · United StatesUniversity of Utah

Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin

NCT04765137·Phase 2
Recruiting

Primary endpoint: Change of MRI whole brain cerebrovascular reactivity (wbCVR)

Interventionalopen20 targetStarted 2021-05Completion 2027-121 site · United StatesJohns Hopkins University

Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy

NCT05586750·Phase 4

Primary endpoint: Free water

InterventionalRandomizedquadruple341 targetStarted 2019-09Completion 2026-092 sites · AustraliaMonash University
FDA Decisions5 records
Approval1 INDICATIONS AND 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 (TEVA)FDA ↗
ANDA220276UNKNOWNStandardOralTablet
Approval1 INDICATIONS AND 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 (RDY)FDA ↗
ANDA214659UNKNOWNStandardOralTablet
Approval1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium t(RDY)FDA ↗
ANDA091650OralTablet
Approval1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium t(RDY)FDA ↗
ANDA202357OralTablet
Approval1 INDICATIONS AND 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 (TEVA)FDA ↗
ANDA078773OralTablet

Frequently asked questions

Who is developing atorvastatin?

atorvastatin is being developed by DR REDDYS LABORATORIES LTD, Teva Pharmaceutical Industries Limited.

How many clinical trials involve atorvastatin?

BioSniper tracks 11 clinical trials involving atorvastatin.

What is atorvastatin's latest FDA decision?

The most recent tracked FDA decision for atorvastatin is Approval for 1 INDICATIONS AND 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 , dated November 13, 2025.