NDAORALTABLETPriority Review
Approved
Jun 2023
Lifecycle
Growth
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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LODOCO (colchicine 0.5 mg tablets) is an oral anti-inflammatory alkaloid approved to reduce the risk of major cardiovascular events (MI, stroke, coronary revascularization, cardiovascular death) in adults with established atherosclerotic disease or multiple cardiovascular risk factors. It works by inhibiting β-tubulin polymerization to suppress neutrophil activation and inflammasome-mediated interleukin-1β production, thereby reducing high-sensitivity C-reactive protein levels. The exact mechanism in cardiovascular prevention remains incompletely understood.
$0.046BPart D
Growth8.0 years to LOEEarly-stage growth product with minimal current market penetration; small, agile team structure likely with significant upside if label expansion succeeds.
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.