NDAORALCAPSULE
Approved
Dec 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
EZALLOR SPRINKLE (rosuvastatin) by Fosun Pharma 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 2018.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EZALLOR SPRINKLE is an oral sprinkle capsule formulation of rosuvastatin, a statin that lowers cholesterol by inhibiting HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis. It is indicated for patients requiring cholesterol management, with the sprinkle formulation providing flexibility in dosing for diverse patient populations. The drug works by reducing hepatic cholesterol production and increasing LDL receptor activity.
$0.114MPart D
Peak9.6 years to LOEProduct is in peak commercial phase with modest Part D volume; brand team is likely focused on defending market share against generic erosion rather than growth initiatives.
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 (20)
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.