Colchicine
As of the edition of 20 October 2026, Colchicine is a small molecule: marketed, first approved in 1960 (ES); acts on TUBB, TUBB1 and TUBB2A and 6 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Colbenemid
- First approved
- 1 May 1960 (ES)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Agepha Pharma s.r.o; 10 holders in all
- Registered trials
- 191, 14 stopped early
- Disease areas
- Heart and blood vessels; Bones, joints and muscles; Nutrition and metabolism; Inherited and neonatal; Infections; Lungs and airways
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
8 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product8 company-target rows are on route B because of Colchicine.
See the 8 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| TUBB4A | Tubulin beta-4A chain | P04350 |
| TUBB | Tubulin beta chain | P07437 |
| TUBB4B | Tubulin beta-4B chain | P68371 |
| TUBB3 | Tubulin beta-3 chain | Q13509 |
| TUBB2A | Tubulin beta-2A chain | Q13885 |
| TUBB8 | Tubulin beta-8 chain | Q3ZCM7 |
| TUBB6 | Tubulin beta-6 chain | Q9BUF5 |
| TUBB2B | Tubulin beta-2B chain | Q9BVA1 |
| TUBB1 | Tubulin beta-1 chain | Q9H4B7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 16 | 5 | 5 | 2 |
| Phase 1 | 31 | 25 | 2 | 0 |
| Phase 2 | 45 | 25 | 12 | 3 |
| Phase 3 | 55 | 22 | 23 | 6 |
| Phase 4 | 44 | 20 | 13 | 3 |
| All trials | 191 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Acquired holder and Lead sponsor of trials | 2007 to now |
| Hikma Pharmaceuticals | Later holder | 2014 to now |
| Hikma International Pharmaceuticals | Acquired holder | 2015 to now |
| Scilex Pharmaceuticals | Acquired holder | 2022 to now |
| Agepha Pharma Fz | Later holder | 2023 to now |
| Agepha Pharma s.r.o | Applicant | 2026 to now |