Market atlas / Inflammaging / Colchicine
Colchicine (anti-inflammatory)
repurposedsmall-moleculenlrp3-inflammasome-inhibitionmicrotubule-inhibitionanti-inflammatory● crp
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
| Market | Stage | Since | Indication / class / form |
|---|---|---|---|
| US | approved | not dated | class Alkaloid [EPC] |
| UK | approved | 2022-07-28 | indication 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… |
| CN | approved | not dated | form Active pharmaceutical ingredient, chemical drug |
| JP | approved | 2016-09-28 | indication 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… |
| CH | approved | 2021-06-24 | indication Gouty arthritis, pericarditis, familial Mediterranean fever |
| SG | approved | 2003-05-23 | form Tablet, oral, prescription only |
| IL | approved | 2021-06-30 | indication Prevention and treatment of gout and FMF (familial mediterranean fever). |
| KR | approved | 1988-02-29 | class 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 endpoint | Markets measuring it |
|---|---|
| Number of atrial fibrillation (AF) recurrence | CH |
| Major adverse cardiovascular and limb events (MACE or MALE) | CH |
| Edoxaban vs. no active treatment | CH |
| Colchicine vs no active treatment | CH |
| VAS for shoulder pain | IL |
| Shoulder range of motion | IL |
| Shoulder pain and disability index | IL |
| Recurrence of atrial fibrillation | IL |
| Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months. | IL |
| Serum colchicine level | KR |
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
2016
MarketJP: approved-other (PMDA-approved (Japan))
PMDA:colchicine (2016-09-28) · machine-extracted
2021
MarketCH: approved-other (Swissmedic-authorised (Switzerland))
Swissmedic:colchicin (2021-06-24) · machine-extracted
2021
MarketIL: approved-other (Israel MoH-registered)
IsraelMoH:colchicine (2021-06-30) · machine-extracted
2022
MarketUK: approved-other (MHRA-authorised (UK), per eMC SmPC)
EMC:colchicine (product 14362) · 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