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Market atlas / Inflammaging / Colchicine

Colchicine (anti-inflammatory)

repurposedsmall-moleculenlrp3-inflammasome-inhibitionmicrotubule-inhibitionanti-inflammatory● crp
PositionEvidenceRulers

Stage by geography

Same development stage across markets, but South Korea reached it about 34 years before United Kingdom.
signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSUKCNJPCHSGILKR
MarketsUS United States FDAUK United Kingdom MHRA / NICECN China NMPAIN India CDSCOJP Japan PMDACH Switzerland SwissmedicSG Singapore HSAIL Israel Ministry of HealthKR South Korea MFDS

What each market approved it for

MarketStageSinceIndication / class / form
USapprovednot datedclass Alkaloid [EPC]
UKapproved2022-07-28indication Adults Colchicine is indicated for the treatment of acute gout Colchicine is indicated for the prophylaxis of a gout attack during initiation of urate-lowering…
CNapprovednot datedform Active pharmaceutical ingredient, chemical drug
JPapproved2016-09-28indication A drug with a new additional indication and a new dosage for the treatment of familial Mediterranean fever. [Public knowledge-based application after PAFSC's…
CHapproved2021-06-24indication Gouty arthritis, pericarditis, familial Mediterranean fever
SGapproved2003-05-23form Tablet, oral, prescription only
ILapproved2021-06-30indication Prevention and treatment of gout and FMF (familial mediterranean fever).
KRapproved1988-02-29class Gout treatment agents [MFDS 03940]

China registers · NMPA

What each NMPA register actually approved. Reference approval NMPA H53020821. Domestic generics vs imported originator.

17domestic approvals
Forms listed
2
Product
Colchicine
Form
active pharmaceutical ingredient
Origin
China
Approved
2026-01-14
Approval no
NMPA H53020821

Biomarker trends

no biomarker readings yet

Studies

The studies on Colchicine, what they found, in whom and how strongly, are on its evidence page, each linked to its source.

What the trials measure

Registered primary outcomes this development's trials are powered on, commonest first (ClinicalTrials.gov). What is measured, across markets.
Registered primary endpointMarkets measuring it
Number of atrial fibrillation (AF) recurrenceCH
Major adverse cardiovascular and limb events (MACE or MALE)CH
Edoxaban vs. no active treatmentCH
Colchicine vs no active treatmentCH
VAS for shoulder painIL
Shoulder range of motionIL
Shoulder pain and disability indexIL
Recurrence of atrial fibrillationIL
Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months.IL
Serum colchicine levelKR

Connections

no connections yet

Trajectory

1988
MarketKR: approved-other (MFDS-approved (South Korea))
MFDS:colchicine (1988-02-29) · machine-extracted
2003
MarketSG: approved-other (HSA-registered (Singapore))
HSA:colchicine (2003-05-23) · machine-extracted
2014
ProfileColchicine (anti-inflammatory)
NCT02139046 · machine-extracted
2016
MarketJP: approved-other (PMDA-approved (Japan))
PMDA:colchicine (2016-09-28) · machine-extracted
2021
MarketCH: approved-other (Swissmedic-authorised (Switzerland))
2021
MarketIL: approved-other (Israel MoH-registered)
2022
MarketUK: approved-other (MHRA-authorised (UK), per eMC SmPC)
EMC:colchicine (product 14362) · machine-extracted
2026
MarketCH: rct (clinical trials (highest phase 3))
NCT02898610 · machine-extracted
2026
MarketIL: rct (clinical trials (highest phase 2))
NCT05677555 · machine-extracted
2026
MarketJP: rct (clinical trials (highest phase 2))
NCT03376698 · machine-extracted
2026
MarketKR: signal (clinical trials (highest phase ?))
NCT06543082 · machine-extracted
2026
MarketSG: rct (clinical trials (highest phase 2))
NCT00819585 · machine-extracted
2026
MarketCN: approved-other (NMPA-approved (domestic))
NMPA:NMPA H53020821 · machine-extracted
2026
MarketUS: approved-other (approved, marketed)
NDA204820 · machine-extracted
Get into the weeds: raw observations + provenance
mfds__dev_colchicine__KR  2026-07-13  kind=geography_stage  verify=M
   MFDS-approved in South Korea: Colchicine (Colchine Tab.), first approval 1988-02-29. [MFDS drug product-approval list]
   source MFDS:colchicine (1988-02-29)  https://nedrug.mfds.go.kr/pbp/CCBGA01

hsa__dev_colchicine__SG  2026-07-13  kind=geography_stage  verify=M
   HSA-registered in Singapore: COLCHICINE (COLCITEX TABLET 0.6 mg), first registration 2003-05-23. [HSA Listing of Registered Therapeutic Products]
   source HSA:colchicine (2003-05-23)  https://data.gov.sg/datasets/d_767279312753558cbf19d48344577084/view

colch_facets  2026-06-29  kind=facets  verify=M
   Colchicine facets
   source NCT02139046  https://clinicaltrials.gov/study/NCT02139046

pmda__dev_colchicine__JP  2026-07-13  kind=geography_stage  verify=M
   PMDA-approved in Japan: Colchicine (Colchicine Tablets 0.5 mg "Takata" (Takata Pharmaceutical Co.,Ltd.)), first approval 2016-09-28. [PMDA List of Approved Drugs]
   source PMDA:colchicine (2016-09-28)  https://www.pmda.go.jp/files/000281190.pdf

swissmedic__dev_colchicine__CH  2026-07-13  kind=geography_stage  verify=M
   Swissmedic-authorised in Switzerland: colchicinum (COLCTAB 1 mg, tablets), first authorisation 2021-06-24. [Swissmedic list of authorised medicinal products]
   source Swissmedic:colchicin (2021-06-24)  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/erweiterte_ham_ind.xlsx

israelmoh__dev_colchicine__IL  2026-07-13  kind=geography_stage  verify=M
   Registered in Israel (Israeli Drug Registry): COLCHICINE 500 MCG (COLCHICINE 0.5 mg ), current registration 2021-06-30. [Israel MoH Drug Registry]
   source IsraelMoH:colchicine (2021-06-30)  https://israeldrugs.health.gov.il/

colch_uk  2026-07-14  kind=geography_stage  verify=M
   UK marketing authorisation (MHRA), per the eMC SmPC: Colchicine 500 mcg Tablets [active substance: colchicine], first authorised 2022-07-28. [electronic Medicines Compendium, medicines.org.uk]
   source EMC:colchicine (product 14362)  https://www.medicines.org.uk/emc/product/14362/smpc

ctsearch__CH__dev_colchicine  2026-07-10  kind=geography_stage  verify=M
   colchicine: 8 registered trial(s) in CH, highest phase 3 [NCT02898610]
   source NCT02898610  https://clinicaltrials.gov/study/NCT02898610

ctsearch__IL__dev_colchicine  2026-07-10  kind=geography_stage  verify=M
   colchicine: 10 registered trial(s) in IL, highest phase 2 [NCT05677555]
   source NCT05677555  https://clinicaltrials.gov/study/NCT05677555

ctsearch__JP__dev_colchicine  2026-07-10  kind=geography_stage  verify=M
   colchicine: 2 registered trial(s) in JP, highest phase 2 [NCT03376698]
   source NCT03376698  https://clinicaltrials.gov/study/NCT03376698

ctsearch__KR__dev_colchicine  2026-07-10  kind=geography_stage  verify=M
   colchicine: 4 registered trial(s) in KR, highest phase ? [NCT06543082]
   source NCT06543082  https://clinicaltrials.gov/study/NCT06543082

ctsearch__SG__dev_colchicine  2026-07-10  kind=geography_stage  verify=M
   colchicine: 2 registered trial(s) in SG, highest phase 2 [NCT00819585]
   source NCT00819585  https://clinicaltrials.gov/study/NCT00819585

nmpa__dev_colchicine__CN  2026-07-13  kind=geography_stage  verify=M
   NMPA-approved in China (colchicine): 17 domestic approval(s) (e.g. Colchicine, China). Reference NMPA H53020821.
   source NMPA:NMPA H53020821  https://www.nmpa.gov.cn/datasearch/home-index.html

openfda__NDA204820__US  2026-07-13  kind=geography_stage  verify=M
   FDA-approved in the US (COLCHICINE); approved, marketed [NDA204820]
   source NDA204820  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA204820