MedPath

Colchicine

Generic Name
Colchicine
Brand Names
Colcrys, Gloperba, Lodoco, Mitigare
Drug Type
Small Molecule
Chemical Formula
C22H25NO6
CAS Number
64-86-8
Unique Ingredient Identifier
SML2Y3J35T

Overview

Colchicine is an alkaloid drug derived from a plant belonging to the Lily family, known as Colchicum autumnale, or "autumn crocus." Its use was first approved by the FDA in 1961. Colchicine is used in the treatment of gout flares and Familial Mediterranean fever, and prevention of major cardiovascular events. It has also been investigated in other inflammatory and fibrotic conditions.

Indication

Colchicine is indicated for the prophylaxis and treatment of gout flares. It is also indicated in Familial Mediterranean fever (FMF) in children and adults of four years of age and older. It is also indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. Some off-label uses of colchicine include the treatment of the manifestations of Behcet's syndrome, pericarditis, and postpericardiotomy syndrome.

Associated Conditions

  • Behcet's Syndrome
  • Cardiovascular Mortality
  • Coronary Revascularization
  • Familial Mediterranean Fever (FMF )
  • Gout Flares
  • Myocardial Infarction
  • Pericarditis
  • Postpericardiotomy Syndrome
  • Stroke

Research Report

Published: May 16, 2025

Colchicine: A Comprehensive Clinical and Pharmacological Review

I. Introduction to Colchicine

A. Overview and Historical Context

Colchicine is an alkaloid medication with a long-standing history in therapeutics, primarily recognized for its utility in treating inflammatory conditions such as gout and Familial Mediterranean Fever (FMF). More recently, its therapeutic scope has expanded to include the prevention of major cardiovascular events.[1] The historical significance of colchicine is profound; it represents one of the oldest known remedies still in contemporary medical use. Its origins as an herbal treatment for joint pain can be traced back to ancient Egyptian medical texts, such as the Ebers Papyrus, dating to approximately 1500 BCE. The active alkaloid, colchicine itself, was subsequently isolated from its plant source in the early 19th century.[2]

The journey of colchicine from an ancient herbal remedy to a regulated pharmaceutical agent is noteworthy. Despite its millennia of use, formal approval by regulatory bodies like the U.S. Food and Drug Administration (FDA) occurred relatively late in its history. This delay is partly attributable to initiatives such as the FDA's Unapproved Drug Initiative (UDI), which aimed to bring historically unapproved but widely utilized medications under rigorous regulatory oversight. The first FDA-regulated colchicine product, Colcrys, entered the market in 2009.[2] This regulatory pathway had substantial implications for the market availability and pricing of colchicine, aspects that will be explored further in this report. The evolving understanding of colchicine's therapeutic actions is also evident in its expanding indications. Initially valued for its anti-inflammatory effects in crystal-induced arthropathies and autoinflammatory syndromes, its role in cardiovascular protection underscores a deeper appreciation of its pleiotropic effects and the pivotal role of inflammation in a wider spectrum of d

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/27
Not Applicable
Recruiting
2025/07/14
Not Applicable
Recruiting
Shanghai Tongji Hospital, Tongji University School of Medicine
2025/06/25
Phase 3
Not yet recruiting
Beijing Tiantan Hospital
2025/06/18
Phase 2
Recruiting
2025/04/16
Phase 3
Not yet recruiting
2025/03/03
Phase 2
Not yet recruiting
2025/02/26
Phase 1
Recruiting
Zaeema Kanwal
2025/02/20
Phase 3
Active, not recruiting
2025/02/06
Phase 2
Not yet recruiting
2025/01/31
Phase 4
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
American Health Packaging
60687-389
ORAL
0.6 mg in 1 1
6/9/2023
Bryant Ranch Prepack
63629-8362
ORAL
0.6 mg in 1 1
11/7/2023
Bryant Ranch Prepack
72162-1855
ORAL
0.6 mg in 1 1
1/13/2022
AGEPHA Pharma USA, LLC
82867-001
ORAL
0.5 mg in 1 1
8/24/2023
Proficient Rx LP
63187-292
ORAL
0.6 mg in 1 1
10/1/2022
Major Pharmaceuticals
0904-7120
ORAL
0.6 mg in 1 1
5/18/2021
Rising Pharma Holdings, Inc.
16571-832
ORAL
0.5 mg in 1 1
11/6/2023
direct rx
72189-249
ORAL
0.6 mg in 1 1
7/23/2021
Ascend Laboratories, LLC
67877-589
ORAL
0.6 mg in 1 1
1/13/2022
American Health Packaging
60687-358
ORAL
0.6 mg in 1 1
10/4/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
COLCHICINE TABLETS BP 500 mcg
SIN06229P
TABLET
500 mcg
5/20/1991
COLCHICINE HALEWOOD TABLET 500 MCG
SIN15572P
TABLET
500 mcg
11/1/2018
COLCITEX TABLET 0.6 mg
SIN12301P
TABLET
0.6 mg
5/23/2003

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SCIAT HP
bio active canada ltd.
02233679
Liquid - Oral
30 X
5/26/1998
EDEMNIX HP
terra botanica products ltd.
02233383
Liquid - Oral
30 X
5/25/1998
PMS-COLCHICINE
02402181
Tablet - Oral
0.6 MG
2/27/2013
ARIBOSAN B31 - LIQ
professional health products
02158876
Liquid - Oral
6 D / ML
12/31/1996
COLCHICINE
euro-pharm international canada inc
00206032
Tablet - Oral
1 MG
12/31/1950
ART HP
bio active canada ltd.
02233554
Liquid - Oral
30 X
5/26/1998
JNT-NIX HP
terra botanica products ltd.
02233340
Liquid - Oral
30 X
6/3/1998
VERBAN ONT
welcker-lyster ltd., division of technilab inc.
00206342
Ointment - Topical
100 MG / 100 G
12/31/1963
SCIATINIX HP
terra botanica products ltd.
02233362
Liquid - Oral
30 X
5/25/1998
EURO-COLCHICINE
euro-pharm international canada inc
02456559
Tablet - Oral
0.6 MG
10/10/2019

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
COLCHICINA RIA 1 MG COMPRIMIDOS EFG
Ria Generics Limited
84475
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COLCHICINA TIOFARMA 1 MG COMPRIMIDOS
Tiofarma B.V.
86658
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COLCHICINA INDOCO 0,5 MG COMPRIMIDOS EFG
Indoco Remedies Czech S.R.O.
90154
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COLCAMEXX 0,5 MG COMPRIMIDOS EFG
Pharmaselect International Beteiligungs Gmbh
86430
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COLCHICINA STRIDES 0,5 MG COMPRIMIDOS EFG
88127
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COLCHICINA SEID 0,5 MG COMPRIMIDOS
Seid S.A.
78947
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized
COLCHICINA TIOFARMA 0,5 MG COMPRIMIDOS
Tiofarma B.V.
86659
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
COLCHICINA SEID 1 mg COMPRIMIDOS
Seid S.A.
33720
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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