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
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
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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PHARMACOR COLCHICINE colchicine 500 microgram tablet bottle | 335433 | Medicine | A | 3/22/2021 | |
LENGOUT colchicine 0.5mg tablet bottle | 97499 | Medicine | A | 10/10/2003 | |
Colgout | 337362 | Medicine | A | 6/2/2020 | |
COLCINE colchicine 500 microgram tablet bottle | 335430 | Medicine | A | 3/22/2021 | |
COLCHICINE-WGR colchicine 500 microgram tablet bottle | 464065 | Medicine | A | 12/23/2024 | |
PHARMACOR COLCHICINE colchicine 500 microgram tablet blister pack | 335432 | Medicine | A | 3/22/2021 | |
Colgout 0.5mg Tablets bottle | 27909 | Medicine | A | 10/21/1991 | |
COLCINE colchicine 500 microgram tablet blister pack | 335431 | Medicine | A | 3/22/2021 |
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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