Market atlas / SGLT2 inhibitors / Canagliflozin

Canagliflozin (SGLT2 inhibitor)

repurposedsmall-moleculesglt2-inhibitionglucosuriacardiometabolic● hba1c

Stage by geography

Same development stage across markets, but Switzerland reached it about 7 years before United Kingdom.

signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSUKCNJPCHSGINILKR+1 stages

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	form Oral
UK	approved	2021-01-01	indication Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to…
CN	approved	not dated	form Tablet, chemical drug
IN	RCT	2009-09-01	not published
JP	approved	2014-07-04	indication A drug with a new active ingredient indicated for the treatment of type 2 diabetes mellitus.
CH	approved	2014-01-29	indication Oral antidiabetic
SG	approved	2014-02-21	form Tablet, film coated, oral, prescription only
IL	RCT	not dated	not published
KR	RCT	not dated	not published

China registers · NMPA

What each NMPA register actually approved. Reference approval NMPA H20233077. Domestic generics vs imported originator.

17domestic approvals

Forms listed: 1
Product: Canagliflozin Tablets
Form: tablet
Strength: 0.1g (calc. as C₂₄H₂₅FO₅S)
Holder: Hangzhou Zhongmei Huadong Pharmaceutical
Origin: China
Approved: 2023-01-19
Approval no: NMPA H20233077

2imported approvals

approval count only; per-product detail not captured

Biomarker trends

no biomarker readings yet

Studies

The studies on Canagliflozin, 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
Change in HbA1c From Baseline to Week 26	IL, IN, SG
Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular…	IN, JP, KR
Change in HbA1c From Baseline to Week 52	IL, KR
Change From Baseline in Mean Hemoglobin A1c (HbA1c)	IN
Change From Baseline in Mean Weight	IN
Plasma concentrations of canagliflozin JNJ-28431754)	IN
Urine concentrations of canagliflozin (JNJ-28431754)	IN
Change from baseline in 24-hour urine glucose excretion	IN
Change from baseline in the area under the plasma glucose concentration-time curve (AUC)	IN
Change from baseline in the area under the plasma insulin concentration-time curve (AUC)	IN

Connections

Trajectory

2009

Relatedcontrasts with Metformin

NCT00968812 · machine-extracted

2009

ProfileCanagliflozin (SGLT2 inhibitor)

NCT00968812 · machine-extracted

2009

MarketIN: rct (clinical trials (highest phase 3))

NCT00968812 · machine-extracted

2014

MarketCH: approved-other (Swissmedic-authorised (Switzerland))

Swissmedic:canagliflozin (2014-01-29) · machine-extracted

2014

MarketSG: approved-other (HSA-registered (Singapore))

HSA:canagliflozin (2014-02-21) · machine-extracted

2014

MarketJP: approved-other (PMDA-approved (Japan))

PMDA:canagliflozin (2014-07-04) · machine-extracted

2021

MarketUK: approved-other (MHRA-authorised (UK), per eMC SmPC)

EMC:canagliflozin (product 8855) · machine-extracted

2026

MarketCH: rct (clinical trials (highest phase 3))

NCT01106651 · machine-extracted

2026

MarketIL: rct (clinical trials (highest phase 3))

NCT00968812 · machine-extracted

2026

MarketJP: rct (clinical trials (highest phase 3))

NCT03436693 · machine-extracted

2026

MarketKR: rct (clinical trials (highest phase 3))

NCT00968812 · machine-extracted

2026

MarketSG: rct (clinical trials (highest phase 3))

NCT01106677 · machine-extracted

2026

MarketCN: approved-other (NMPA-approved (domestic + imported))

NMPA:NMPA H20233077 · machine-extracted

2026

MarketUS: approved-other (approved, marketed)

NDA204042 · machine-extracted

Get into the weeds: raw observations + provenance

cana_edge_metf  2026-06-29  kind=edge  verify=M
   both metabolic, SGLT2 glucosuria vs AMPK/insulin sensitization
   source NCT00968812  https://clinicaltrials.gov/study/NCT00968812

cana_facets  2026-06-29  kind=facets  verify=M
   Canagliflozin facets
   source NCT00968812  https://clinicaltrials.gov/study/NCT00968812

cana_in  2026-06-29  kind=geography_stage  verify=M
   Canagliflozin: registered phase 3 trials in India [NCT00968812]
   source NCT00968812  https://clinicaltrials.gov/study/NCT00968812

swissmedic__dev_canagliflozin__CH  2026-07-13  kind=geography_stage  verify=M
   Swissmedic-authorised in Switzerland: canagliflozinum (Invokana 100 mg, film-coated tablets), first authorisation 2014-01-29. [Swissmedic list of authorised medicinal products]
   source Swissmedic:canagliflozin (2014-01-29)  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/erweiterte_ham_ind.xlsx

hsa__dev_canagliflozin__SG  2026-07-13  kind=geography_stage  verify=M
   HSA-registered in Singapore: Canagliflozin Hemihydrate 306mg eqv Canagliflozin (INVOKANA™ FILM-COATED TABLETS 300 MG), first registration 2014-02-21. [HSA Listing of Registered Therapeutic Products]
   source HSA:canagliflozin (2014-02-21)  https://data.gov.sg/datasets/d_767279312753558cbf19d48344577084/view

pmda__dev_canagliflozin__JP  2026-07-13  kind=geography_stage  verify=M
   PMDA-approved in Japan: Canagliflozin hydrate (Canaglu Tablets 100 mg (Mitsubishi Tanabe Pharma Corporation)), first approval 2014-07-04. [PMDA List of Approved Drugs]
   source PMDA:canagliflozin (2014-07-04)  https://www.pmda.go.jp/files/000281190.pdf

cana_uk  2026-07-14  kind=geography_stage  verify=M
   UK marketing authorisation (MHRA), per the eMC SmPC: Invokana 100 mg film-coated tablets [active substance: canagliflozin hemihydrate], first authorised 2021-01-01. [electronic Medicines Compendium, medicines.org.uk]
   source EMC:canagliflozin (product 8855)  https://www.medicines.org.uk/emc/product/8855/smpc

ctsearch__CH__dev_canagliflozin  2026-07-10  kind=geography_stage  verify=M
   canagliflozin: 1 registered trial(s) in CH, highest phase 3 [NCT01106651]
   source NCT01106651  https://clinicaltrials.gov/study/NCT01106651

ctsearch__IL__dev_canagliflozin  2026-07-10  kind=geography_stage  verify=M
   canagliflozin: 4 registered trial(s) in IL, highest phase 3 [NCT00968812]
   source NCT00968812  https://clinicaltrials.gov/study/NCT00968812

ctsearch__JP__dev_canagliflozin  2026-07-10  kind=geography_stage  verify=M
   canagliflozin: 8 registered trial(s) in JP, highest phase 3 [NCT03436693]
   source NCT03436693  https://clinicaltrials.gov/study/NCT03436693

ctsearch__KR__dev_canagliflozin  2026-07-10  kind=geography_stage  verify=M
   canagliflozin: 7 registered trial(s) in KR, highest phase 3 [NCT00968812]
   source NCT00968812  https://clinicaltrials.gov/study/NCT00968812

ctsearch__SG__dev_canagliflozin  2026-07-10  kind=geography_stage  verify=M
   canagliflozin: 2 registered trial(s) in SG, highest phase 3 [NCT01106677]
   source NCT01106677  https://clinicaltrials.gov/study/NCT01106677

nmpa__dev_canagliflozin__CN  2026-07-13  kind=geography_stage  verify=M
   NMPA-approved in China (canagliflozin): 17 domestic approval(s) (e.g. Canagliflozin Tablets, 0.1g (calc. as C₂₄H₂₅FO₅S) , Hangzhou Zhongmei Huadong Pharmaceutical, China); 2 imported approval(s). Reference NMPA H20233077.
   source NMPA:NMPA H20233077  https://www.nmpa.gov.cn/datasearch/home-index.html

openfda__NDA204042__US  2026-07-13  kind=geography_stage  verify=M
   FDA-approved in the US (CANAGLIFLOZIN); approved, marketed [NDA204042]
   source NDA204042  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA204042