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 3h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EZALLOR SPRINKLE is a sprinkle capsule formulation of rosuvastatin, an HMG-CoA reductase inhibitor (statin) approved in December 2018 for cholesterol management. It works by inhibiting the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, reducing cholesterol synthesis. This formulation enables dosing flexibility, particularly beneficial for pediatric and patients with swallowing difficulties.
$0.114MPart D
Peak9.4 years to LOEPeak-stage product with modest Medicare Part D penetration (902 claims, $114K spending in 2023) suggests a niche formulation with limited mainstream adoption; commercial teams are likely focused on specialty segments and market access.
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 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.