NDAORALTABLET
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
COLCRYS (colchicine) by Molecular Devices is elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Approved for gout. First approved in 2009.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLCRYS (colchicine) is an oral small-molecule anti-inflammatory agent approved in 2009 that works by inhibiting inflammasome activation and disrupting microtubule polymerization to reduce neutrophil and monocyte-mediated inflammation. Originally indicated for gout, the drug has expanded into cardiovascular and inflammatory conditions including acute coronary syndrome, heart failure, myocarditis, and COVID-19. The mechanism addresses a broad inflammatory pathway relevant across multiple therapeutic areas.
$1MPart D
LOE ApproachingProduct is in lifecycle decline with minimal Part D spend ($1M) and only 2,691 claims in 2023, indicating limited scale and likely consolidating or defensive team structure.
Mechanism of Action
elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Additionally, colchicine disrupts cytoskeletal functions through inhibition of β-tubulin…
Indications (1)
Clinical Trials (20)
A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF
Started Sep 2025
3 enrolled
Familial Mediterranean Fever (FMF )
Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage
Started Jun 2025
80 enrolled
Cerebral Amyloid AngiopathyIntracerebral Hemorrhage Lobar
MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
Started Aug 2024
490 enrolled
Acute Coronary Syndrome
Efficacy and Safety of Colchicine After PCI
Started Jul 2024
8,862 enrolled
Coronary Heart DiseasePercutaneous Coronary InterventionColchicine
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
Started Nov 2023
80 enrolled
CardiomyopathiesMyocarditisInflammatory Cardiomyopathy+2 more
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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.