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 Yesterday · 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 in 2023 for reducing cardiovascular events in patients with established atherosclerotic disease. It works by inhibiting microtubule polymerization and inflammasome activation in neutrophils and monocytes, thereby reducing systemic inflammation markers like hs-CRP. The mechanism of action in cardiovascular prevention is not fully understood but demonstrates clinical efficacy in secondary prevention.
$0.046BPart D
Peak7.8 years to LOEEarly-stage peak commercial phase with minimal Medicare penetration suggests small, focused brand team with opportunity for market expansion in secondary cardiovascular prevention.
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.