Market atlas / SGLT2 inhibitors / Dapagliflozin

Dapagliflozin (SGLT2 inhibitor)

repurposedsmall-moleculesglt2-inhibitionglucosuriacardiometabolic● hba1c

Stage by geography

Same development stage across markets, but Japan reached it about 12 years before United Kingdom.

signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSUKCNJPCHSGILKRIN+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	2025-10-17	indication Type 2 diabetes mellitus Dapagliflozin is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2…
CN	approved	not dated	form Tablet, chemical drug
IN	RCT	2024-12-16	not published
JP	approved	2014-03-24	indication Drugs with a new active ingredient indicated for the treatment of type 2 diabetes mellitus.
CH	approved	2014-08-19	indication Type 2 diabetes, heart failure, chronic kidney disease
SG	approved	2014-04-28	form Tablet, film coated, oral, prescription only
IL	approved	2019-07-31	indication Type 2 diabetes mellitus Forxiga is indicated in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an…
KR	approved	2020-04-02	class Diabetes agents [MFDS 03960]

China registers · NMPA

What each NMPA register actually approved. Reference approval NMPA H20255293. Domestic generics vs imported originator.

92domestic approvals

Forms listed: 4
Product: Dapagliflozin Tablets
Form: tablet
Strength: 10mg (calc. as C₂₁H₂₅ClO₆)
Holder: Tiandi Hengyi Pharmaceutical
Origin: China
Approved: 2025-09-02
Approval no: NMPA H20255293

17imported approvals

approval count only; per-product detail not captured

Biomarker trends

no biomarker readings yet

Studies

The studies on Dapagliflozin, 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 eGFR from baseline	IL, IN, JP, KR
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke	IL, IN, JP, KR
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	IL, IN, JP
Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 16 (Higher Scores…	JP, KR
Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Physical Limitation Score (KCCQ-PLS) at Week 16 (Higher Scores…	JP, KR
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 16 (Larger Distances Represent Better Functional Capacity)	JP, KR
Intraepithelial nerve fiber density	IN
Pharmacokinetics 1: Dapagliflozin, respectively Empagliflozin half-life	CH
Pharmacokinetics 2: Dapagliflozin, respectively Empagliflozin Volume of distribution	CH
Pharmacokinetics 3: Dapagliflozin, respectively Empagliflozin AUC	CH

Connections

Trajectory

2014

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

PMDA:dapagliflozin (2014-03-24) · machine-extracted

2014

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

HSA:dapagliflozin (2014-04-28) · machine-extracted

2014

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

Swissmedic:dapagliflozin (2014-08-19) · machine-extracted

2019

Relatedshares a mechanism with Empagliflozin

NCT03899402 · machine-extracted

2019

ProfileDapagliflozin (SGLT2 inhibitor)

NCT03899402 · machine-extracted

2019

MarketIL: approved-other (Israel MoH-registered)

IsraelMoH:dapagliflozin (2019-07-31) · machine-extracted

2020

MarketKR: approved-other (MFDS-approved (South Korea))

MFDS:dapagliflozin (2020-04-02) · machine-extracted

2024

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

NCT06317051 · machine-extracted

2025

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

EMC:dapagliflozin (product 101534) · machine-extracted

2026

MarketCH: rct (clinical trials (highest phase 2))

NCT06012266 · machine-extracted

2026

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

NCT03199053 · machine-extracted

2026

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

NCT06268873 · machine-extracted

2026

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

NCT02096705 · machine-extracted

2026

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

NCT02096705 · machine-extracted

2026

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

NMPA:NMPA H20255293 · machine-extracted

2026

MarketUS: approved-other (approved, marketed)

NDA202293 · machine-extracted

Get into the weeds: raw observations + provenance

pmda__dev_dapagliflozin__JP  2026-07-13  kind=geography_stage  verify=M
   PMDA-approved in Japan: Dapagliflozin propylene glycolate hydrate (Forxiga Tablets 5 mg Forxiga Tablets 10 mg (Bristol-Myers K.K.)), first approval 2014-03-24. [PMDA List of Approved Drugs]
   source PMDA:dapagliflozin (2014-03-24)  https://www.pmda.go.jp/files/000281190.pdf

hsa__dev_dapagliflozin__SG  2026-07-13  kind=geography_stage  verify=M
   HSA-registered in Singapore: Dapagliflozin propanediol 6.15mg eqv dapagliflozin (FORXIGA TABLET 5MG), first registration 2014-04-28. [HSA Listing of Registered Therapeutic Products]
   source HSA:dapagliflozin (2014-04-28)  https://data.gov.sg/datasets/d_767279312753558cbf19d48344577084/view

swissmedic__dev_dapagliflozin__CH  2026-07-13  kind=geography_stage  verify=M
   Swissmedic-authorised in Switzerland: dapagliflozinum (Forxiga 5 mg, film-coated tablets), first authorisation 2014-08-19. [Swissmedic list of authorised medicinal products]
   source Swissmedic:dapagliflozin (2014-08-19)  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/erweiterte_ham_ind.xlsx

dapa_edge_empa  2026-06-29  kind=edge  verify=M
   both SGLT2 inhibitors
   source NCT03899402  https://clinicaltrials.gov/study/NCT03899402

dapa_facets  2026-06-29  kind=facets  verify=M
   Dapagliflozin facets
   source NCT03899402  https://clinicaltrials.gov/study/NCT03899402

israelmoh__dev_dapagliflozin__IL  2026-07-13  kind=geography_stage  verify=M
   Registered in Israel (Israeli Drug Registry): DAPAGLIFLOZIN PROPANEDIOL 12.30 MG/DOSE (FORXIGA 10 MG), current registration 2019-07-31. [Israel MoH Drug Registry]
   source IsraelMoH:dapagliflozin (2019-07-31)  https://israeldrugs.health.gov.il/

mfds__dev_dapagliflozin__KR  2026-07-13  kind=geography_stage  verify=M
   MFDS-approved in South Korea: Dapagliflozin (Dapozin Tab. 10mg), first approval 2020-04-02. [MFDS drug product-approval list]
   source MFDS:dapagliflozin (2020-04-02)  https://nedrug.mfds.go.kr/pbp/CCBGA01

dapa_in  2026-06-29  kind=geography_stage  verify=M
   Dapagliflozin: registered phase 3 trials in India [NCT06317051]
   source NCT06317051  https://clinicaltrials.gov/study/NCT06317051

dapa_uk  2026-07-14  kind=geography_stage  verify=M
   UK marketing authorisation (MHRA), per the eMC SmPC: Dapagliflozin 10 mg film coated tablets [active substance: dapagliflozin propanediol monohydrate], first authorised 2025-10-17. [electronic Medicines Compendium, medicines.org.uk]
   source EMC:dapagliflozin (product 101534)  https://www.medicines.org.uk/emc/product/101534/smpc

ctsearch__CH__dev_dapagliflozin  2026-07-10  kind=geography_stage  verify=M
   dapagliflozin: 5 registered trial(s) in CH, highest phase 2 [NCT06012266]
   source NCT06012266  https://clinicaltrials.gov/study/NCT06012266

ctsearch__IL__dev_dapagliflozin  2026-07-10  kind=geography_stage  verify=M
   dapagliflozin: 11 registered trial(s) in IL, highest phase 3 [NCT03199053]
   source NCT03199053  https://clinicaltrials.gov/study/NCT03199053

ctsearch__JP__dev_dapagliflozin  2026-07-10  kind=geography_stage  verify=M
   dapagliflozin: 31 registered trial(s) in JP, highest phase 3 [NCT06268873]
   source NCT06268873  https://clinicaltrials.gov/study/NCT06268873

ctsearch__KR__dev_dapagliflozin  2026-07-10  kind=geography_stage  verify=M
   dapagliflozin: 62 registered trial(s) in KR, highest phase 3 [NCT02096705]
   source NCT02096705  https://clinicaltrials.gov/study/NCT02096705

ctsearch__SG__dev_dapagliflozin  2026-07-10  kind=geography_stage  verify=M
   dapagliflozin: 6 registered trial(s) in SG, highest phase 3 [NCT02096705]
   source NCT02096705  https://clinicaltrials.gov/study/NCT02096705

nmpa__dev_dapagliflozin__CN  2026-07-13  kind=geography_stage  verify=M
   NMPA-approved in China (dapagliflozin): 92 domestic approval(s) (e.g. Dapagliflozin Tablets, 10mg (calc. as C₂₁H₂₅ClO₆), Tiandi Hengyi Pharmaceutical, China); 17 imported approval(s). Reference NMPA H20255293.
   source NMPA:NMPA H20255293  https://www.nmpa.gov.cn/datasearch/home-index.html

openfda__NDA202293__US  2026-07-13  kind=geography_stage  verify=M
   FDA-approved in the US (DAPAGLIFLOZIN); approved, marketed [NDA202293]
   source NDA202293  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA202293