Market atlas / SGLT2 inhibitors / Empagliflozin

Empagliflozin (SGLT2 inhibitor)

repurposedsmall-moleculesglt2-inhibitionglucosuriacardiometabolic● hba1c

Stage by geography

Same development stage across markets, but South Korea reached it about 11 years before China.

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	class Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
UK	approved	2021-01-01	indication Type 2 diabetes mellitus Empagliflozin is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2…
CN	approved	2025-09-23	form Tablet, chemical drug
IN	RCT	2024-08-30	not published
JP	approved	2014-12-26	indication Drugs with a new active ingredient indicated for the treatment of type 2 diabetes mellitus.
CH	approved	2014-11-12	indication Type 2 diabetes, prevention of cardiovascular events, heart failure
SG	approved	2014-12-03	form Tablet, film coated, oral, prescription only
IL	approved	2020-07-31	indication JARDIANCE 10mg is indicated: •to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. •as an adjunct to…
KR	approved	2014-08-12	class Diabetes agents [MFDS 03960]

China registers · NMPA

What each NMPA register actually approved. Reference approval NMPA H20255560. Domestic generics vs imported originator.

139domestic approvals

Forms listed: 1
Product: Empagliflozin Tablets
Form: tablet
Strength: 10mg
Holder: Jiangsu Kanion Pharmaceutical
Origin: China
Approved: 2025-09-23
Approval no: NMPA H20255560

5imported approvals

approval count only; per-product detail not captured

Biomarker trends

no biomarker readings yet

Studies

The studies on Empagliflozin, 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
Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart…	IN, JP, KR
Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)	IN, JP, SG
Maximum concentration obtained (Cmax)	IN
AUC from the 0 to infinity (AUC0-inf)	IN
Time of the maximum measured plasma concentration (Tmax)	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
Primary outcome component 1 - calcium oxalate supersaturation in urine (empagliflozin treatment)	CH
Primary outcome component 1 - calcium oxalate supersaturation in urine (placebo treatment)	CH

Connections

Trajectory

2014

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

MFDS:empagliflozin (2014-08-12) · machine-extracted

2014

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

Swissmedic:empagliflozin (2014-11-12) · machine-extracted

2014

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

HSA:empagliflozin (2014-12-03) · machine-extracted

2014

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

PMDA:empagliflozin (2014-12-26) · machine-extracted

2020

MarketIL: approved-other (Israel MoH-registered)

IsraelMoH:empagliflozin (2020-07-31) · machine-extracted

2021

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

EMC:empagliflozin (product 5441) · machine-extracted

2024

Relatedshares a mechanism with Canagliflozin

NCT06531824 · machine-extracted

2024

ProfileEmpagliflozin (SGLT2 inhibitor)

NCT06531824 · machine-extracted

2024

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

NCT06531824 · machine-extracted

2025

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

NMPA:NMPA H20255560 · machine-extracted

2026

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

NCT06653738 · machine-extracted

2026

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

NCT04509674 · machine-extracted

2026

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

NCT04509674 · machine-extracted

2026

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

NCT04509674 · machine-extracted

2026

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

NCT07064473 · machine-extracted

2026

MarketUS: approved-other (approved, marketed)

NDA204629 · machine-extracted

Get into the weeds: raw observations + provenance

mfds__dev_empagliflozin__KR  2026-07-13  kind=geography_stage  verify=M
   MFDS-approved in South Korea: Empagliflozin (Jardiance tablets 10 mg), first approval 2014-08-12. [MFDS drug product-approval list]
   source MFDS:empagliflozin (2014-08-12)  https://nedrug.mfds.go.kr/pbp/CCBGA01

swissmedic__dev_empagliflozin__CH  2026-07-13  kind=geography_stage  verify=M
   Swissmedic-authorised in Switzerland: empagliflozinum (Jardiance 25 mg, film-coated tablets), first authorisation 2014-11-12. [Swissmedic list of authorised medicinal products]
   source Swissmedic:empagliflozin (2014-11-12)  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/erweiterte_ham_ind.xlsx

hsa__dev_empagliflozin__SG  2026-07-13  kind=geography_stage  verify=M
   HSA-registered in Singapore: Empagliflozin (JARDIANCE FILM-COATED TABLETS 10MG), first registration 2014-12-03. [HSA Listing of Registered Therapeutic Products]
   source HSA:empagliflozin (2014-12-03)  https://data.gov.sg/datasets/d_767279312753558cbf19d48344577084/view

pmda__dev_empagliflozin__JP  2026-07-13  kind=geography_stage  verify=M
   PMDA-approved in Japan: Empagliflozin (Jardiance Tablets 25 mg Jardiance Tablets 10 mg (Nippon Boehringer Ingelheim Co., Ltd.)), first approval 2014-12-26. [PMDA List of Approved Drugs]
   source PMDA:empagliflozin (2014-12-26)  https://www.pmda.go.jp/files/000281190.pdf

israelmoh__dev_empagliflozin__IL  2026-07-13  kind=geography_stage  verify=M
   Registered in Israel (Israeli Drug Registry): EMPAGLIFLOZIN 10 MG (JARDIANCE 10 MG), current registration 2020-07-31. [Israel MoH Drug Registry]
   source IsraelMoH:empagliflozin (2020-07-31)  https://israeldrugs.health.gov.il/

empa_uk  2026-07-14  kind=geography_stage  verify=M
   UK marketing authorisation (MHRA), per the eMC SmPC: Empagliflozin 10 mg film-coated tablets (previously known as Jardiance) [active substance: empagliflozin], first authorised 2021-01-01. [electronic Medicines Compendium, medicines.org.uk]
   source EMC:empagliflozin (product 5441)  https://www.medicines.org.uk/emc/product/5441/smpc

empa_edge_cana  2026-06-29  kind=edge  verify=M
   both SGLT2 inhibitors
   source NCT06531824  https://clinicaltrials.gov/study/NCT06531824

empa_facets  2026-06-29  kind=facets  verify=M
   Empagliflozin facets
   source NCT06531824  https://clinicaltrials.gov/study/NCT06531824

empa_in  2026-06-29  kind=geography_stage  verify=M
   Empagliflozin: registered phase 3 trials in India [NCT06531824]
   source NCT06531824  https://clinicaltrials.gov/study/NCT06531824

empa_cn  2026-06-29  kind=geography_stage  verify=M
   NMPA-approved in China (empagliflozin): 139 domestic approval(s) (e.g. Empagliflozin Tablets, 10mg, Jiangsu Kanion Pharmaceutical, China); 5 imported approval(s). Reference NMPA H20255560.
   source NMPA:NMPA H20255560  https://www.nmpa.gov.cn/datasearch/home-index.html

ctsearch__CH__dev_empagliflozin  2026-07-10  kind=geography_stage  verify=M
   empagliflozin: 15 registered trial(s) in CH, highest phase 3 [NCT06653738]
   source NCT06653738  https://clinicaltrials.gov/study/NCT06653738

ctsearch__IL__dev_empagliflozin  2026-07-10  kind=geography_stage  verify=M
   empagliflozin: 9 registered trial(s) in IL, highest phase 3 [NCT04509674]
   source NCT04509674  https://clinicaltrials.gov/study/NCT04509674

ctsearch__JP__dev_empagliflozin  2026-07-10  kind=geography_stage  verify=M
   empagliflozin: 26 registered trial(s) in JP, highest phase 3 [NCT04509674]
   source NCT04509674  https://clinicaltrials.gov/study/NCT04509674

ctsearch__KR__dev_empagliflozin  2026-07-10  kind=geography_stage  verify=M
   empagliflozin: 41 registered trial(s) in KR, highest phase 3 [NCT04509674]
   source NCT04509674  https://clinicaltrials.gov/study/NCT04509674

ctsearch__SG__dev_empagliflozin  2026-07-10  kind=geography_stage  verify=M
   empagliflozin: 6 registered trial(s) in SG, highest phase 3 [NCT07064473]
   source NCT07064473  https://clinicaltrials.gov/study/NCT07064473

openfda__NDA204629__US  2026-07-13  kind=geography_stage  verify=M
   FDA-approved in the US (EMPAGLIFLOZIN); approved, marketed [NDA204629]
   source NDA204629  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA204629