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Lorelco (PROBUCOL)
Lorelco (PROBUCOL) is a small molecule drug originally developed by, currently owned by, and approved by the FDA in 1977 for the treatment of hypercholesterolemia and hyperlipidemia. It targets the serine protease hepsin and works by inhibiting the breakdown of cholesterol in the body. As an off-patent medication with no active Orange Book patents, Lorelco is available as a branded product. Key safety considerations include its low bioavailability of 5%. Lorelco's commercial status is off-patent, with no generic manufacturers.
At a glance
| Generic name | PROBUCOL |
|---|---|
| Drug class | probucol |
| Target | Serine protease hepsin |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1977 |
Approved indications
- Hypercholesterolemia
- Hyperlipidemia
Common side effects
Key clinical trials
- Expanded Access Program for R007 (Probucol) Tablets in Adults With Mitochondrial Disease and Chronic Kidney Disease
- To Compare the Effect of Concomitant Administration of Probucol and Cilostazol With Probucol Single Treatment on the Atherosclerosis Related Markers (Including the Thickness of the Achilles Tendon) and Evaluate Safety (Based on Atorvastatin Treatment) in Severe Hypercholesterolemia Subject (PHASE4)
- Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker (PHASE4)
- Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke
- The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques (PHASE4)
- Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis (PHASE3)
- Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety (PHASE2)
- Safety and Pharmacokinetics of Probucol and Cilostazol (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lorelco CI brief — competitive landscape report
- Lorelco updates RSS · CI watch RSS