NDAORALTABLET
Approved
Aug 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
64
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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CRESTOR (rosuvastatin) is an oral HMG-CoA reductase inhibitor (statin) that lowers LDL cholesterol by inhibiting the rate-limiting enzyme in cholesterol synthesis. It is indicated for dyslipidemia and cardiovascular risk reduction in patients with elevated cholesterol. The drug works by blocking mevalonate production, a key precursor in the cholesterol biosynthetic pathway.
$0.039BPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with moderate Medicare utilization; commercial teams should expect budget reductions and shifting focus to lifecycle extension or line extension 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 (64)
A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol
Started Oct 2026
24 enrolled
Healthy Male Volunteers
A Clinical Trial to Evaluate the Effects of MK-4646 on Rosuvastatin in Healthy Participants (MK-4646-007)
Started Sep 2026
16 enrolled
Healthy
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
Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants
Started May 2026
20 enrolled
Drug Drug InteractionPharmacokinetic ProfilesSafty
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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.