Colchicine
Colbenemid, Colcrys, Gloperba, Mitigare, Proben-c (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, glycine receptor subunit alpha-2, and neutrophil gelatinase-associated lipocalin.
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COVID-19
Commercial
Trade Name
FDA
EMA
Colcrys, Gloperba, Mitigare (generic drugs available since 1982-01-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Colchicine
Colchicine
+
Probenecid
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COLBENEMID | Merck KGaA | N-012383 DISCN | 1982-01-01 | 1 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| colchicine | ANDA | 2021-12-27 |
| colcrys | New Drug Application | 2022-11-08 |
| gloperba | New Drug Application | 2021-01-07 |
| mitigare | New Drug Application | 2020-06-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amyloidosis | EFO_1001875 | D000686 | E85 |
| biliary liver cirrhosis | — | D008105 | K74.3 |
| familial mediterranean fever | — | D010505 | M04.1 |
| gout | EFO_0004274 | D006073 | M10 |
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, 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
203 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | 3 | 11 | 9 | 2 | 4 | 25 | |
| Gout | D006073 | EFO_0004274 | M10 | 3 | 9 | 2 | 5 | 2 | 21 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 3 | 11 | 1 | 1 | 15 |
| Pharmacokinetics | D010599 | 12 | — | — | 1 | — | 13 | ||
| Coronary artery disease | D003324 | I25.1 | — | 3 | 2 | 4 | — | 9 | |
| Healthy volunteers/patients | — | 7 | — | — | 2 | — | 9 | ||
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 3 | 3 | 1 | 2 | 8 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | 2 | 1 | 5 | — | 7 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 1 | — | 3 | 1 | 1 | 6 |
| Pericarditis | D010493 | EFO_0007427 | I30 | 1 | 1 | 2 | 1 | — | 5 |
Show 17 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | 1 | 4 | 4 | — | 1 | 9 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 3 | — | — | 4 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 3 | — | — | 3 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | 2 | — | — | 2 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | 1 | — | — | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 2 | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | — | — | 2 |
| Non-st elevated myocardial infarction | D000072658 | — | — | 1 | — | 1 | 2 | ||
| Aortic valve stenosis | D001024 | EFO_0000266 | Q25.1 | — | 1 | 2 | — | — | 2 |
| Coronary disease | D003327 | 1 | — | 1 | — | — | 2 |
Show 19 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic nephropathies | D003928 | EFO_0000401 | 1 | 2 | — | — | 1 | 3 | |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 3 | — | — | — | 3 |
| Hyperuricemia | D033461 | — | 3 | — | — | — | 3 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 2 | — | — | — | 2 |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | 2 | — | — | — | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 2 | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | 1 | 2 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | C22.0 | — | 1 | — | — | — | 1 | |
| Cholangiocarcinoma | D018281 | C22.1 | — | 1 | — | — | — | 1 |
Show 16 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 | ||
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | C80 | 1 | — | — | — | — | 1 | |
| Radiotherapy | D011878 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Treatment adherence and compliance | D000074822 | — | — | — | — | 1 | 1 | ||
| Essential hypertension | D000075222 | I10 | — | — | — | — | 1 | 1 | |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | — | 1 | 1 | |
| Carotid stenosis | D016893 | — | — | — | — | 1 | 1 | ||
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | — | — | 1 | 1 |
| Abdominal aortic aneurysm | D017544 | EFO_0004214 | — | — | — | — | 1 | 1 | |
| Fever | D005334 | HP_0001945 | R50.9 | — | — | — | — | 1 | 1 |
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 (P99024)
Alternate
GLRA1
GLRA1
BRD4
BRD4
GLRA2
GLRA2
LCN2
LCN2
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,946 adverse events reported
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