TheraRadar
Data updated: May 26, 2026

LIPTRUZET (atorvastatin calcium)

Trial Activity: Stable 4 active trials
Cardiovascular Approved 2013-05-03
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

General Hospital of Shenyang Military Region conducting 2 trials (14%)
37 indications explored (Broad Platform)
→ stroke, ischemic (2 trials)
→ atherosclerosis, cerebral (2 trials)
→ periodontitis (2 trials)
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Discontinued
First Approved
2013-05-03
Routes
ORAL
Dosage Forms
TABLET

Companies

Merck
Active Ingredient: ATORVASTATIN CALCIUM , EZETIMIBE

LIPTRUZET Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 2013 to 2024
Oct 2024 SUPPL
Label · Labeling
FDA Letter Label
Sep 2020 SUPPL
Label · Labeling
FDA Letter Label
Sep 2017 SUPPL
Label · Labeling
FDA Letter Label

What LIPTRUZET Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

LIPTRUZET FDA Label Details

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Data Sources

FDA Approval: NDA200153 → Patents: FDA Orange Book → 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