Colchicine
Colchicine, Gloperba, Lodoco, Mitigare (colchicine) is a small molecule pharmaceutical. Colchicine was first approved as Colbenemid on 1982-01-01. It is used to treat amyloidosis, biliary liver cirrhosis, familial mediterranean fever, and gout in the USA. The pharmaceutical is active against tubulin beta chain. In addition, it is known to target glycine receptor subunit alpha-1, bromodomain-containing protein 4, and glycine receptor subunit alpha-2.
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Commercial
Trade Name
FDA
EMA
Colchicine, Gloperba, Mitigare (discontinued: Colchicine, Colcrys)
CombinationsCol-probenecid, Probenecid colchicine (discontinued: Colbenemid, Proben-c, Probenecid colchicine, Probenecid w/ colchicine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Colchicine
+
Probenecid
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COLBENEMID | Merck & Co | N-012383 DISCN | 1982-01-01 | 1 products, RLD |
Hide discontinued
Colchicine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MITIGARE | Hikma Pharmaceuticals | N-204820 RX | 2014-09-26 | 1 products, RLD, RS |
| GLOPERBA | Scilex Pharmaceuticals | N-210942 RX | 2019-01-30 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| colchicine | ANDA | 2024-10-10 |
| colcrys | New Drug Application | 2023-12-29 |
| gloperba | New Drug Application | 2024-11-01 |
| lodoco | New Drug Application | 2024-08-09 |
| mitigare | New Drug Application | 2024-05-16 |
| probenecid and colchicine | ANDA | 2023-11-06 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Colchicine, Gloperba, Scilex Pharms | |||
| 10226423 | 2037-12-20 | DP | |
| 9907751 | 2036-11-22 | DP | |
| 10383820 | 2036-11-22 | DP | U-2814 |
| 10383821 | 2036-11-22 | DP | |
| Colchicine, Lodoco, Agepha Pharma Fz | |||
| 9744144 | 2035-01-22 | U-3643 | |
| 10206891 | 2035-01-22 | U-3641 | |
| 10265281 | 2035-01-22 | U-3639 | |
| 10842762 | 2035-01-22 | U-3640 | |
| 11026899 | 2035-01-22 | U-3639 | |
| 11026900 | 2035-01-22 | U-3639 | |
| 11026901 | 2035-01-22 | U-3638 | |
| 10130585 | 2034-12-31 | U-3642 | |
| Colchicine, Mitigare, Hikma Intl Pharms | |||
| 8927607 | 2033-08-22 | U-1020 | |
| 9399036 | 2033-08-22 | U-1020 | |
| 9555029 | 2033-08-22 | U-1020 | |
| 9675613 | 2033-08-22 | U-1020 | |
| 9789108 | 2033-08-22 | U-1020 | |
| Colchicine, Colcrys, Takeda Pharms Usa | |||
| 7820681 | 2029-02-17 | U-1020 | |
| 7906519 | 2029-02-17 | U-1116 | |
| 7915269 | 2029-02-17 | U-1007 | |
| 8440721 | 2029-02-17 | U-1007 | |
| 8440722 | 2029-02-17 | U-1020 | |
| 7601758 | 2029-02-10 | U-1007 | |
| 7619004 | 2028-12-03 | U-1020 | |
| 7935731 | 2028-12-03 | U-1116 | |
| 7964647 | 2028-10-06 | U-1007 | |
| 7964648 | 2028-10-06 | U-1161 | |
| 7981938 | 2028-10-06 | U-1166 | |
| 8093296 | 2028-10-06 | U-1007 | |
| 8093297 | 2028-10-06 | U-1161 | |
| 8093298 | 2028-10-06 | U-1116 | |
| 8097655 | 2028-10-06 | U-1020 | |
| 8415395 | 2028-10-06 | U-1007 | |
| 8415396 | 2028-10-06 | U-1007 | |
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01C: Plant alkaloids and other natural products, antineoplastic drugs
— L01CC: Colchicine derivatives, antineooplastic
M: Musculo-skeletal system drugs
— M04: Antigout preparations
— M04A: Antigout preparations
— M04AC: Preparations with no effect on uric acid metabolism
— M04AC01: Colchicine
HCPCS
No data
Clinical
Clinical Trials
284 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gout | D006073 | EFO_0004274 | M10 | 4 | 13 | 4 | 12 | 3 | 36 |
| Covid-19 | D000086382 | — | — | 5 | 14 | 11 | 2 | 7 | 34 |
| Inflammation | D007249 | MP_0001845 | — | 2 | 12 | 9 | 3 | 3 | 26 |
| Coronary artery disease | D003324 | — | I25.1 | 2 | 5 | 9 | 9 | 1 | 25 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | 1 | 5 | 5 | 7 | 6 | 23 |
| Infarction | D007238 | EFO_0009463 | — | 1 | 5 | 4 | 6 | 6 | 21 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 4 | 14 | 1 | 1 | 19 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | 6 | 7 | 5 | 1 | 19 |
| Familial mediterranean fever | D010505 | — | M04.1 | 1 | 6 | 3 | 2 | 6 | 18 |
| Syndrome | D013577 | — | — | — | 4 | 7 | 4 | 3 | 17 |
Show 40 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | 3 | 3 | — | 1 | 8 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 2 | 4 | — | 1 | 7 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 2 | — | 2 | 5 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | 1 | 1 | — | 2 | 5 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 5 | — | — | 5 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | 2 | — | 2 | 4 |
| Postpericardiotomy syndrome | D011185 | EFO_1001404 | I97.0 | — | 1 | 3 | — | — | 4 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 3 | — | — | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | 1 | — | 1 | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | — | 1 | 3 |
Show 51 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperuricemia | D033461 | HP_0002149 | — | 1 | 3 | — | — | — | 4 |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | 2 | — | — | 2 | 4 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | 2 | 3 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 2 | — | — | 1 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 2 | — | — | 1 | 3 |
| Communicable diseases | D003141 | — | — | — | 1 | — | — | 1 | 2 |
| Virus diseases | D014777 | — | B34 | 1 | 1 | — | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | 2 | — | — | — | 2 |
Show 31 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 1 | — | — | — | — | 1 |
| Renal replacement therapy | D017582 | — | — | 1 | — | — | — | — | 1 |
| Crush injuries | D000071576 | — | T14.8 | 1 | — | — | — | — | 1 |
| Radiotherapy | D011878 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 1 | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 1 | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Hyperphosphatemia | D054559 | HP_0002905 | — | — | — | — | — | 1 | 1 |
Show 25 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Colchicine |
| INN | — |
| Description | (S)-colchicine is a colchicine that has (S)-configuration. It is a secondary metabolite, has anti-inflammatory properties and is used to treat gout, crystal-induced joint inflammation, familial Mediterranean fever, and many other conditions. It has a role as a mutagen, an anti-inflammatory agent and a gout suppressant. It is a colchicine and an alkaloid. It is an enantiomer of a (R)-colchicine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2 |
Target
Agency Approved
TUBB
TUBB
Organism
Homo sapiens
Gene name
TUBB
Gene synonyms
TUBB5
NCBI Gene ID
Protein name
tubulin beta chain
Protein synonyms
beta Ib tubulin, epididymis secretory sperm binding protein, tubulin beta-1 chain, Tubulin beta-5 chain, tubulin, beta polypeptide
Uniprot ID
Mouse ortholog
Tubb5 (22154)
tubulin beta-5 chain (Q3UF52)
Alternate
GLRA1
GLRA1
BRD4
BRD4
GLRA2
GLRA2
Variants
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Financial
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Estimated US medical usage
Colchicine
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Colchicine
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Probenecid
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,943 adverse events reported
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