NDAORALGRANULES, EXTENDED RELEASE
Approved
Feb 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
ASPRUZYO SPRINKLE (ranolazine) by Piramal Pharma is cytochrome p450 3a inhibitors [moa]. First approved in 2022.
Drug data last refreshed 34m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ASPRUZYO SPRINKLE is an extended-release oral granule formulation of ranolazine, a cytochrome P450 3A inhibitor used as an anti-anginal agent for chronic angina management. It works by inhibiting late phase inward sodium current in cardiac cells, reducing intracellular calcium overload and improving myocardial function without affecting heart rate or blood pressure. The sprinkle formulation enables flexible dosing for patients who cannot swallow intact capsules.
$0.139MPart D
Peak11.6 years to LOEProduct is at peak commercial maturity with modest Medicare utilization; brand team likely focused on market maintenance and patient access optimization rather than rapid expansion.
Mechanism of Action
Cytochrome P450 3A Inhibitors
Pharmacologic Class:
Anti-anginal
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis
Started Jun 2018
14 enrolled
ALS
A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency
Started Jun 2018
20 enrolled
Angina
Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention (REPTAR)
Started Jan 2017
40 enrolled
Angina
Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy
Started Oct 2016
26 enrolled
HCM - Hypertrophic Non-Obstructive Cardiomyopathy
Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents
Started Aug 2015
5 enrolled
Angina
Worked on ASPRUZYO SPRINKLE at Piramal Pharma? Share your interview experience or compensation data (+7 days Pro)
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.