Last reviewed · How we verify
Colcrys (COLCHICINE)
Colcrys works by inhibiting the activity of a specific enzyme called serine/threonine-protein kinase pim-1.
Colcrys (Colchicine) is a small molecule alkaloid drug originally developed by Merck and currently owned by Scilex Pharmaceuticals. It targets the serine/threonine-protein kinase pim-1 and has been FDA-approved since 1961 for various indications including chronic gouty arthritis, familial Mediterranean fever, and gout. Colcrys is available as a generic medication with multiple manufacturers. Key safety considerations include its potential for gastrointestinal side effects and interactions with other medications. The commercial status of Colcrys is complex, with some formulations still under patent.
At a glance
| Generic name | COLCHICINE |
|---|---|
| Sponsor | Scilex Pharms |
| Drug class | Alkaloid [EPC] |
| Target | Serine/threonine-protein kinase pim-1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1961 |
Mechanism of action
The mechanism by which Colchicine Tablets, USP exert their beneficial effect in patients with FMF has not been fully elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1. Additionally, colchicine disrupts cytoskeletal functions through inhibition of -tubulin polymerization into microtubules, and consequently prevents the activation, degranulation and migration of neutrophils thought to mediate some gout symptoms.
Approved indications
- Atherosclerosis
- Cardiovascular disease
- Chronic gouty arthritis
- Familial Mediterranean fever
- Gout
- Gout Prevention
Common side effects
- Diarrhea
- Pharyngolaryngeal pain
- Vomiting
- Nausea
- Abdominal pain
- Fatigue
- Gout
- Headache
- Abdominal Discomfort
- General Disorders and Administration Site Conditions
- Metabolic and Nutrition Disorders
- Nervous System Disorders
Drug interactions
- amprenavir
- aprepitant
- atazanavir
- azithromycin
- captopril
- carvedilol
- ciclosporin
- ciprofloxacin
- conivaptan
- darunavir
- diltiazem
- dronedarone
Key clinical trials
- Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk (PHASE3)
- Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine (PHASE4)
- Proteomic and Inflammatory Omics Changes With Colchicine Therapy in Coronary Heart Disease (PHASE4)
- Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease (EARLY_PHASE1)
- Efficacy and Safety of Thalidomide for Pediatric PFAPA Syndrome (NA)
- The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial (PHASE4)
- Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement (NA)
- COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 7619004 | 2028-12-03 | Method of Use |
| 7820681 | 2029-02-17 | Method of Use |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Colcrys CI brief — competitive landscape report
- Colcrys updates RSS · CI watch RSS
- Scilex Pharms portfolio CI