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Drug

Colchicine

Approved · FDA
ClassTubulin inhibitorEmerging researchLate-stage developmentRising momentum
Also known as Colchicine-Probenecid, Colcrys, Gloperba, Lodoco+4 more

Colchicine-Probenecid, Colcrys, Gloperba, Lodoco, Mitigare, Colchicin, Colchicina, Colchicinum.

6
Research papers
46
Active clinical trials
15
Protein targets
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis

Clinical trial2026-07-10Results expected Q3 2031 · ClinicalTrials.gov

Colchicine's Role in Cardiovascular Disease Management.

Research2024-03-21Arteriosclerosis, thrombosis, and vascular biology

Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.

Research2019-11-16The New England journal of medicine

Approval: COLCHICINE (NDA210942)

Regulatory2019-01-30FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Colchicine
Aliases & brands
Colchicine-ProbenecidColcrysGloperbaLodocoMitigareColchicinColchicinaColchicinum
RxNorm CUI
2683
ChEMBL ID
CHEMBL107
ATC codes
M04AC01
UNII
SML2Y3J35T
Primary mechanism
Tubulin inhibitor
Regulatory jurisdictions
fdamhraema

Pharmacology & targets

15 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tubulin beta-4B chain
TUBB4B · P68371
INHIBITORTubulin inhibitor
Tubulin beta-1 chain
TUBB1 · Q9H4B7
INHIBITORTubulin inhibitor
Tubulin alpha-3C chain
TUBA3C · P0DPH7
INHIBITORTubulin inhibitor
Tubulin alpha-4A chain
TUBA4A · P68366
INHIBITORTubulin inhibitor
Tubulin beta-3 chain
TUBB3 · Q13509
INHIBITORTubulin inhibitor
Tubulin alpha-1A chain
TUBA1A · Q71U36
INHIBITORTubulin inhibitor
Tubulin beta-4A chain
TUBB4A · P04350
INHIBITORTubulin inhibitor
Tubulin beta-8 chain
TUBB8 · Q3ZCM7
INHIBITORTubulin inhibitor
Tubulin beta chain
TUBB · P07437
INHIBITORTubulin inhibitor
Tubulin alpha-1B chain
TUBA1B · P68363
INHIBITORTubulin inhibitor
Tubulin alpha-1C chain
TUBA1C · Q9BQE3
INHIBITORTubulin inhibitor
Tubulin alpha-3E chain
TUBA3E · Q6PEY2
INHIBITORTubulin inhibitor
Tubulin beta-2A chain
TUBB2A · Q13885
INHIBITORTubulin inhibitor
Tubulin beta-2B chain
TUBB2B · Q9BVA1
INHIBITORTubulin inhibitor
Tubulin beta-6 chain
TUBB6 · Q9BUF5
INHIBITORTubulin inhibitor

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2019-01-30
Latest approval
2024-08-28
Authorities
FDA · EMA · MHRA
Total events
5
fdaU.S. Food and Drug Administration· 3 events
2024-08-28Indication expansion
Indication expansion: COLCHICINE (NDA210942)
Evidence ↗
2021-02-11Supplemental approval
Supplemental approval: COLCHICINE (NDA210942)
Evidence ↗
2019-01-30Approval
Approval: COLCHICINE (NDA210942)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2026-05-22CHMP positive opinion
CHMP positive opinion: Colchicine Agepha Pharma (EMA)
Indication: Indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in patients with atherosclerotic disease or with multipleShow full indication

Indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in patients with atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Colchicine: extremely toxic in overdose
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

185 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
185
registered trials across all phases
LATEST COMPLETION 2025
46
Active studies
41
Recruiting
111
Late-stage (III+)
89
Completed
50
Discontinued
PHASE DISTRIBUTIONn = 185
Early Phase 12Phase 124Phase 1 / 24Phase 244Phase 2 / 38Phase 347Phase 444Phase N / A12

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19972024
Most influential
Recent papers
Major research themes4
Cardiovascular Diseases1Colchicine1Coronary Angiography1Percutaneous Coronary Intervention1
Journals, researchers & institutions
Top journals
  • American heart journal1
  • Arteriosclerosis, thrombosis, and vascular biology1
  • Circulation1
  • JAMA network open1
  • The Journal of neuroscience : the official journal of the Society for Neuroscience1
  • The New England journal of medicine1
Leading researchers
  • Abe T1
  • Adams H1
  • Akasheh BF1
  • Alexopoulos D1
  • Alhaddad IA1
  • Amerena J1
  • Angelidis C1
  • Angoulvant D1
Leading institutions
free-text, unnormalised
  • AHEPA Hospital1
  • Alexandra Hospital1
  • Athens Medical Center1
  • Attikon Hospital1
  • Bankstown-Lidcombe Hospital1
  • Brigham and Women's Hospital1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Frequently co-studied with Colchicine in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.