Table 1.
Current/Under Development SGLT2, Dual SGLT1/SGLT2, and SGLT1 Inhibitors
| Drug Name | Target | The Highest Stage of Clinical Trials and Cardiovascular Related Trials | Development Phase | Approval Time for Listing with Cardiovascular Related Indication |
|---|---|---|---|---|
| Canagliflozin | SGLT2 | Phase IV Completed CANVAS Program (NCT01032629) |
Approved by FDA (2013/03) EMA (2013/11) PMDA (2014/07) NMPA (2017/09) |
Not applicable |
| Dapagliflozin | SGLT2 | Phase IV Completed DECLARE-TIMI 58 (NCT01730534) |
Approved by FDA (2014/01) EMA (2012/11) PMDA (2014/03) NMPA (2017/03) |
HF: USA (2020/05) EU (2020/11) Japan (2020/11) China (2021/02) |
| Empagliflozin | SGLT2 | Phase IV Completed EMPA-REG OUTCOME (NCT01131676) |
Approved by FDA (2014/08) EMA (2014/05) PMDA (2014/12) NMPA (2017/09) |
HF: USA (2021/08) EU (2021/06) Japan (2021/11) |
| Luseogliflozin | SGLT2 | Phase IV Completed |
Approved by PMDA (2014/03) |
Not applicable |
| Tofogliflozin | SGLT2 | Phase IV Completed |
Approved by PMDA (2014/03) |
Not applicable |
| Ipragliflozin | SGLT2 | Phase IV Completed |
Approved by PMDA (2014/01) |
Not applicable |
| Ertugliflozin | SGLT2 | Phase IV Completed VERTIS CV (NCT01986881) |
Approved by FDA (2017/12) EMA (2018/03) NMPA (2020/07) |
Not applicable |
| Bexagliflozin | SGLT2 | Phase III Completed NCT03514641 |
Approved by FDA (2023/01) |
Essential hypertension: USA (2023/01) |
| Sotagliflozin | SGLT1 SGLT2 |
Phase III Completed SOLOIST-WHF (NCT03521934) |
Approved by FDA (2023/05) EMA (2019/04) |
HF: USA (2023/05) |
| Mizagliflozin | SGLT1 | Phase II Completed |
Not applicable | Not applicable |
| KGA-2727 | SGLT1 | Preclinical studies | Not applicable | Not applicable |
Notes: HF: Heart failure; FDA: Food and Drug Administration; EMA: European Medicines Agency; PMDA: Pharmaceuticals and Medical Devices Agency; NMPA: National Medical Products Administration; EU: European Union; USA: United States of America.