NDAORALCAPSULE
Approved
Sep 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
MITIGARE (colchicine) by Hikma 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. First approved in 2014.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Mitigare (colchicine) is an oral alkaloid indicated for gout treatment that works by blocking neutrophil-mediated inflammatory responses to monosodium urate crystals. It disrupts microtubule polymerization and inhibits inflammasome activation, reducing IL-1β production and acute flare symptoms. The drug is an established, non-biologic small molecule with a well-understood mechanism used for decades in rheumatology.
$0.025BPart D
Peak7.2 years to LOEPeak lifecycle status with modest $25M Part D spending suggests stable, mature brand with lean commercial infrastructure and limited team expansion opportunities.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.