COLCHICINE

Post-LOE

colchicine

Aurobindo Pharma

ANDAORALCAPSULE

Approved

Apr 2024

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

COLCHICINE (colchicine) by Aurobindo Pharma is colchicine's effectiveness as a treatment for gout has been postulated to be due to its ability to block neutrophil-mediated inflammatory responses induced by monosodium urate crystals in synovial fluid. Approved for gout flares in adults (). First approved in 2024.

Drug data last refreshed 20h ago

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Mechanism of Action

Colchicine's effectiveness as a treatment for gout has been postulated to be due to its ability to block neutrophil-mediated inflammatory responses induced by monosodium urate crystals in synovial fluid. Colchicine disrupts the polymerization of β-tubulin into microtubules, thereby preventing the…

Pharmacologic Class:

Alkaloid

Indications (1)

gout flares in adults ()

Clinical Trials (20)

NCT06666335Phase 4Not Yet Recruiting

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 )

NCT07026994Phase 2Recruiting

Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage

Started Jun 2025

80 enrolled

Cerebral Amyloid AngiopathyIntracerebral Hemorrhage Lobar

NCT06543082Phase 4Recruiting

MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

Started Aug 2024

490 enrolled

Acute Coronary Syndrome

NCT06472908Phase 3Recruiting

Efficacy and Safety of Colchicine After PCI

Started Jul 2024

8,862 enrolled

Coronary Heart DiseasePercutaneous Coronary InterventionColchicine

NCT06158698Phase 3Recruiting

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.