NDAORALSUSPENSION
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
FLOLIPID (simvastatin) by Engine Biosciences is hydroxymethylglutaryl-coa reductase inhibitors [moa]. First approved in 2016.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLOLIPID is an oral suspension formulation of simvastatin, a statin that lowers cholesterol by inhibiting HMG-CoA reductase. It is indicated for reducing cholesterol in patients at risk for cardiovascular disease. The suspension formulation addresses dosing flexibility for patients who cannot take tablets.
$0.005BPart D
Peak3.7 years to LOEProduct is at peak lifecycle with minimal Medicare Part D claims (16 in 2023), indicating modest commercial scale and likely small supporting team.
Mechanism of Action
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants
Started May 2025
49 enrolled
Healthy Participants
Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
Started Oct 2024
90 enrolled
Recurrent Acute PancreatitisChronic Pancreatitis
Bioequivalence Study of Simvastatin 40 mg Film-coated Tablets in Healthy Thai Volunteers
Started Aug 2024
46 enrolled
Healthy Volunteer
Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin
Started Jun 2022
32 enrolled
Healthy Volunteers
Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin
Started Jan 2022
24 enrolled
Drug-drug Interaction
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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.