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 5h 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 patients with hyperlipidemia who require lipid management to reduce cardiovascular risk. The suspension form provides an alternative delivery mechanism for this established small-molecule therapy.
$0.005BPart D
LOE Approaching3.4 years to LOELimited commercial footprint with only 16 Part D claims in 2023 signals a niche product with constrained growth trajectory and likely small dedicated 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)
VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma
Started Sep 2026
52 enrolled
GlioblastomaAstrocytoma, IDH-Mutant, Grade 4
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
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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.