Wednesday, July 8, 2026

Drug profile · INN

colchicine

colchicine (ARX-COLCHICINE) is a tubulin inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: unknown TGA: approved NMPA: clinical trials Musculo-skeletal system (M04) M04AC01
US status approved
Patents linked 10
Pipeline programs 37
News articles 0
Drug details — colchicine
US status
approved
Class
Musculo-skeletal system (M04)
Route
ORAL
Patents
10
Programs
37
Data quality
0.89

Quick answer

colchicine (ARX-COLCHICINE) is a tubulin inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN colchicine
Brand ARX-COLCHICINE
Mechanism Tubulin inhibitor
Target Tubulin
Therapeutic class Musculo-skeletal system (M04)
Route ORAL
Formulation CAPSULE
ATC code M04AC01

Mechanism of action

Tubulin inhibitor

Primary target: Tubulin

Approval history

Authority Status Date
FDA approved
EMA unknown
TGA approved
NMPA clinical trials

Pipeline programs

  1. APHP211429 Phase 3 · PARItec · patients suffering from acute myocarditis confirmed on Cardi
  2. Anakinra 100mg and Placebo Depo-Medrone Phase 3 · United Therapeutics Europe · Gout
  3. COLCHICINE OPOCALCIUM 1 mg, comprimé sécable Phase 3 · PARItec · Stroke, Ischemic, TIA, Cardiac Disease, Atherosclerosis, Myo
  4. Colchicine 0.5 mg Phase 3 · George Institute for · Intracerebral Hemorrhage
  5. Febuxostat IR Phase 3 · Takeda · Gout
  6. High Dose Colchicine (4.8 mg total dose) Phase 3 · Takeda · Gout
  7. Kineret / solution for Familial Mediterranean Fever (F… Phase 3 · PARItec · Familial Mediterranean Fever (FMF)
  8. METFORMIN for PASC: post-acute sequelae of SARS-CoV-2 infection Phase 3 · Disc Medicine · PASC: post-acute sequelae of SARS-CoV-2 infection

Related & competitor drugs

  1. allopurinol Musculo-skeletal system (M04)
  2. brentuximab vedotin Antineoplastic and immunomodulating agents (L01)
  3. cabazitaxel Antineoplastic and immunomodulating agents (L01)
  4. denosumab Musculo-skeletal system (M05)
  5. docetaxel Antineoplastic and immunomodulating agents (L01)
  6. eteplirsen Musculo-skeletal system (M09)
  1. US 11844771

    Methods of treating acute respiratory distress syndrome using colchicine

    Expires Mon Dec 14 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11400063

    Early administration of low-dose colchicine after myocardial infarction

    Expires Mon Jul 28 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9255063

    Colchicine solid-state forms; methods of making; and methods of use thereof

    Expires Mon Feb 04 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 8519002

    Colchicine solid complex; methods of making; and methods of use thereof

    Expires Mon Aug 22 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 8497290

    Thiocolchicine derivatives, method of making and methods of use thereof

    Expires Mon Jul 25 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 8445541

    Methods for concomitant administration of colchicine and a second active agent

    Expires Mon May 16 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 8440722

    Methods for concomitant administration of colchicine and a second active agent

    Expires Mon May 09 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 8440721

    Methods for concomitant administration of colchicine and a second active agent

    Expires Mon May 09 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 8415396

    Colchine compositions and methods

    Expires Mon Apr 04 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 8415395

    Colchicine compositions and methods

    Expires Mon Apr 04 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is colchicine?

colchicine (ARX-COLCHICINE) is a tubulin inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for colchicine?

ARX-COLCHICINE is a marketed brand name for colchicine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of colchicine?

colchicine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.