NDAORALTABLET
Approved
Aug 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
63
Data completeness
5/8 — Partial
CRESTOR (rosuvastatin) by AstraZeneca is hmg‑coa reductase, the rate-limiting enzyme that converts 3‑hydroxy‑3‑methylglutaryl coenzyme a to mevalonate, a precursor of cholesterol. First approved in 2003.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CRESTOR (rosuvastatin) is an oral HMG-CoA reductase inhibitor (statin) approved in 2003 for cholesterol management and cardiovascular risk reduction. It works by inhibiting the rate-limiting enzyme in cholesterol synthesis, effectively lowering LDL cholesterol and triglycerides in patients with dyslipidemia.
$39MPart D
LOE ApproachingDeclining
With LOE approaching and moderate competitive pressure (score: 30), the brand team is likely consolidating and shifting focus from growth to lifecycle extension and generic mitigation strategies.
Mechanism of Action
HMG‑CoA reductase, the rate-limiting enzyme that converts 3‑hydroxy‑3‑methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (63)
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
Started Sep 2026
200 enrolled
Hypercholesterolaemia
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
Started Aug 2026
600 enrolled
Hypercholesterolaemia
A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants
Started Apr 2026
40 enrolled
Healthy Participants
A Study to Learn More About How Safe Nurandociguat is and How it Affects the Way the Body Processes Rosuvastatin and Dabigatran in Healthy Adults
Started Apr 2026
0Chronic Kidney Disease
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Started Mar 2026
48 enrolled
Healthy Volunteers
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.