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colchicine

Trade name: colbenemid

Small moleculeapproved

Approved

Jul 27, 1961

Colchicine is an alkaloid obtained from the plant colchicum autumnale (also known as "meadow saffron"). Colchicine is an alternative medication for those unable to tolerate NSAIDs in gout. Mechanism of action of colchicine is inhibition of microtubule polymerization by binding to tubulin. Availability of tubulin is essential to mitosis, so colchicine effectively unctions as a "mitotic poison" or spindle poison. — NCATS

Clinical trial activity

259 trials · 259 clinical orgs · 36 marketing orgs

Phase 1
45
Phase 2
137
Phase 3
78
Phase 4
54

Earliest trial started Nov 1, 1989 (NCT00004748)

Timeline

1960s

  1. Jul 27, 1961

    Merck — Earliest FDA Approval

  2. Jul 27, 1961

    Merck — Marketing Organization

  3. Jul 27, 1961

    Merck — NDA Organization

1970s

  1. Apr 7, 1975

    Watson Pharmaceuticals — Marketing Organization

  2. Mar 11, 1976

    Beecham — Marketing Organization

  3. Jun 12, 1978

    Ani Pharmaceuticals — Marketing Organization

  4. Sep 6, 1979

    Lederle — Marketing Organization

  5. Sep 6, 1979

    American Cyanamid — Marketing Organization

1980s

  1. Mar 18, 1980

    Sandoz — Marketing Organization

  2. Jan 1, 1989

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jan 1, 1990

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. May 13, 2008

    Novast Labs — Marketing Organization

  3. May 13, 2008

    Ingenus Pharmaceuticals — Marketing Organization

  4. Jul 29, 2009

    Takeda — NDA Secondary Org

  5. Jul 30, 2009

    AR Holding Co Inc — NDA Secondary Org

2010s

  1. Sep 26, 2014

    Hikma — NDA Secondary Org

  2. Feb 12, 2015

    Par Pharmaceuticals — Marketing Organization

  3. Sep 28, 2016

    Amneal Pharmaceuticals — Marketing Organization

  4. Nov 29, 2018

    Endo Pharmaceuticals — Marketing Organization

  5. Nov 29, 2018

    Bristol-Myers Squibb — Marketing Organization

  6. Nov 29, 2018

    PH HEALTH — Marketing Organization

  7. Jan 30, 2019

    Romeg Theraps Llc — NDA Secondary Org

  8. Jan 30, 2019

    Avion Pharmaceuticals — NDA Secondary Org

  9. Jan 30, 2019

    Scilex Pharms Inc — Marketing Organization

  10. Jan 30, 2019

    Sorrento Therapeutics, Inc. — NDA Secondary Org

  11. Feb 8, 2019

    Alkem Labs Ltd — Marketing Organization

  12. Feb 19, 2019

    Zydus Discovery DMCC — Marketing Organization

  13. Jul 31, 2019

    AbbVie — Marketing Organization

  14. Sep 6, 2019

    Dr. Reddy's Laboratories — Marketing Organization

  15. Sep 16, 2019

    Mylan — Marketing Organization

2020s

  1. Feb 5, 2020

    Granules India — Marketing Organization

  2. Aug 13, 2021

    Hetero Labs Ltd — Marketing Organization

  3. Jan 6, 2022

    Aurobindo Pharma — Marketing Organization

  4. Mar 10, 2022

    Strides Pharma Science — Marketing Organization

  5. Jun 16, 2023

    AGEPHA PHARMA FZ — Marketing Organization

  6. Jun 16, 2023

    AGEPHA PHARMA FZ — NDA Secondary Org

  7. Oct 24, 2023

    Rising Pharmaceuticals — Marketing Organization

  8. Apr 29, 2024

    Annora Pharma — Marketing Organization

  9. Feb 13, 2026

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  10. Feb 17, 2026

    Micro Labs Ltd India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • colbenemi

    with probenecid

    Also known as col-probeneci, proben-c

Approval history

  • approvedJul 27, 1961

Chemistry & pharmacology

Loading structure…

SMILES

COC1=CC2=C(C(OC)=C1OC)C3=CC=C(OC)C(=O)C=C3[C@H](CC2)NC(C)=O
Mol. weight
399.437 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • cognivida
  • colchicin
  • colchicin
  • colchicina
  • colchicina
  • colchicine
  • colchicine
  • colchicine
  • colchicine
  • colchicine
  • colchicine
  • colchicine
  • colchicine
  • colchicine
  • colchicine
  • colchicine
  • colchicinum
  • colchicinum
  • colchisol
  • colcin
  • colcrys
  • colcrys

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07232069Phase 3Apr 1, 2026Duke University, Harvard University, Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina at Chapel Hill
NCT07287345Phase 4Dec 31, 2025University of Kentucky
NCT07247734Phase 2Dec 1, 2025University of Copenhagen
NCT06936709Phase 4Dec 1, 2025Geisinger Clinic
NCT07145229Phase 2Aug 26, 2025Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
NCT07143136Early Phase 1 (Phase 1)Aug 10, 2025Assiut University
NCT06802926Phase 4Jul 31, 2025Jiao Tong University
NCT07035405Phase 3Jul 4, 2025Capital Medical University
NCT07064109N/AJul 1, 2025Huazhong University of Science and Technology
NCT07026994Phase 2Jun 18, 2025Chinese Academy of Medical Sciences, Fudan University, Sichuan University
NCT06930885Phase 3Jun 12, 2025Hcor Research Institute, Hospital do Coracao
NCT07129538N/AMay 10, 2025Cairo University
NCT06279000Phase 3Apr 1, 2025Cantonal Hospital of St. Gallen
NCT06855433Phase 2Apr 1, 2025Harvard University
NCT06874192Phase 1Mar 12, 2025Virginia Commonwealth University
NCT06847204Phase 1/Phase 2 (Phase 2)Feb 24, 2025Post-Graduate Medical Institute, Lahore
NCT06813079Phase 2Feb 17, 2025University of Toronto
NCT07280572Phase 3Feb 17, 2025European Clinical Research Alliance for Infectious Diseases (ECRAID), Utrecht University
NCT06998862Phase 3Feb 12, 2025Hospital General Universitario Gregorio Marañon
NCT06768294Phase 2Jan 31, 2025I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Showing 20 of 259 trials
Page 1 / 13

Organizations

Research & Development (259)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mutual PharmaceuticalFor profit222022007
McMaster UniversityAcademic/Hospital12832008
PRACSFor profit10012007
Harvard UniversityAcademic/Hospital7541993
National Heart, Lung, and Blood Institute (NHLBI)Government7031993
TakedaFor profit7532007
University of CopenhagenAcademic/Hospital7742020
Ain Shams UniversityAcademic/Hospital6532020
Assistance Publique - Hôpitaux de ParisAcademic/Hospital6542010
Huazhong University of Science and TechnologyAcademic/Hospital6632013
Maria Vittoria HospitalAcademic/Hospital6222005
New York UniversityAcademic/Hospital6412013
University of MontrealAcademic/Hospital6622014
CymaBay Therapeutics, Inc.For profit5512011
University of Sao PauloAcademic/Hospital5532018
University of TurinAcademic/Hospital5432005
Canadian Institutes of Health Research (CIHR)Academic/Hospital4012014
Chinese Academy of Medical SciencesAcademic/Hospital4232022
Hamilton Health Sciences CorporationAcademic/Hospital4322008
University of AthensAcademic/Hospital4132013
259 organizations
Page 1 / 13

Marketing (43)

OrganizationOrg typeRelationshipDate
AGEPHA PHARMA FZFor profitMKTGJun 16, 2023
AGEPHA PHARMA FZFor profitNDA2Jun 16, 2023
AR Holding Co IncFor profitNDA2Jul 30, 2009
AbbVieFor profitMKTGJul 31, 2019
Alkem Labs LtdFor profitMKTGFeb 8, 2019
American CyanamidFor profitMKTGSep 6, 1979
Amneal PharmaceuticalsFor profitMKTGSep 28, 2016
Ani PharmaceuticalsFor profitMKTGJun 12, 1978
Ani PharmaceuticalsFor profitSYNJun 12, 1978
Annora PharmaFor profitMKTGApr 29, 2024
Aurobindo PharmaFor profitMKTGJan 6, 2022
Avion PharmaceuticalsFor profitNDA2Jan 30, 2019
BeechamFor profitMKTGMar 11, 1976
Bristol-Myers SquibbFor profitMKTGNov 29, 2018
Dr. Reddy's LaboratoriesFor profitSYNSep 6, 2019
Dr. Reddy's LaboratoriesFor profitMKTGSep 6, 2019
Endo PharmaceuticalsFor profitMKTGNov 29, 2018
Granules IndiaFor profitMKTGFeb 5, 2020
Granules IndiaFor profitSYNFeb 5, 2020
Hetero Labs LtdFor profitMKTGAug 13, 2021
HikmaFor profitNDA2Sep 26, 2014
Impax LaboratoriesFor profitMKTG—
Ingenus PharmaceuticalsFor profitMKTGMay 13, 2008
LederleFor profitMKTGSep 6, 1979
Macleods Pharmaceuticals, LtdFor profitMKTGFeb 13, 2026
MerckFor profitMKTGJul 27, 1961
MerckFor profitNDAJul 27, 1961
Micro Labs Ltd IndiaFor profitMKTGFeb 17, 2026
MylanFor profitSYNSep 16, 2019
MylanFor profitMKTGSep 16, 2019
Novast LabsFor profitMKTGMay 13, 2008
PH HEALTHFor profitMKTGNov 29, 2018
Par PharmaceuticalsFor profitMKTGFeb 12, 2015
Rising PharmaceuticalsFor profitMKTGOct 24, 2023
Romeg Theraps LlcFor profitNDA2Jan 30, 2019
SandozFor profitMKTGMar 18, 1980
Scilex Pharms IncFor profitMKTGJan 30, 2019
Sorrento Therapeutics, Inc.For profitNDA2Jan 30, 2019
Strides Pharma ScienceFor profitMKTGMar 10, 2022
TakedaFor profitNDA2Jul 29, 2009
Watson PharmaceuticalsFor profitMKTGApr 7, 1975
Watson PharmaceuticalsFor profitSYNOct 6, 2015
Zydus Discovery DMCCFor profitMKTGFeb 19, 2019