NDAORALTABLETPriority Review
Approved
Jun 2023
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
6/8 — Strong
Priority Review
LODOCO (colchicine tablets 0.5 mg) by Agepha Pharma is 12. Approved for myocardial infarction (mi), stroke, coronary revascularization and 2 more indications. First approved in 2023.
Drug data last refreshed 26m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LODOCO is a 0.5 mg oral colchicine tablet approved in June 2023 for reducing the risk of major adverse cardiovascular events (MI, stroke, coronary revascularization, cardiovascular death) in adults with established atherosclerotic disease or multiple cardiovascular risk factors. It works by disrupting neutrophil activation and inflammasome assembly, reducing inflammatory markers like high-sensitivity C-reactive protein. This repurposing of colchicine represents a novel anti-inflammatory approach to cardiovascular risk reduction.
$0.046MPart D
Peak7.5 years to LOERecently approved product in peak commercial phase with zero competitive pressure, suggesting significant growth opportunity and active brand-building investment across sales, marketing, and medical affairs.
Mechanism of Action
12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism of action of colchicine in the prevention of major cardiovascular events is not understood. However, it is known that colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules and…
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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.