Table 3. Overview of the current regulatory status of SGLT inhibitors for the treatment of diabetes.
SGLT inhibitor | Trial registration number | Daily dose | Approval/developmental status | SGLT selectivity |
---|---|---|---|---|
Dapagliflozin | NA | 5, 10 mg | Approved by EMA (2012/11), FDA (2014/01), PMDA (2014/03) | SGLT2 |
Canagliflozin | NA | 100, 300 mg | Approved by FDA (2013/03), EMA (2013/11) | SGLT2 |
Empagliflozin | NA | 10, 25 mg | Approved by EMA (2014/05), FDA (2014/08) | SGLT2 |
Ipragliflozin | NA | 25, 50 mg | Approved by PMDA (2014/01) | SGLT2 |
Tofogliflozin | NA | 20 mg | Approved by PMDA (2014/3) | SGLT2 |
Luseogliflozin | NA | 2.5, 5 mg | Approved by PMDA (2014/03) | SGLT2 |
Ertugliflozin | NCT01958671 | 5, 10 mg | Phase III recruiting | SGLT2 |
LX4211 | NCT01742208 | Not yet determined | Phase II | SGLT1/SGLT2 |
GSK189075 | NCT00500331 | Not yet determined | Phase II | SGLT2 |
EGT0001442 | NCT01377844 | Not yet determined | Phase II | SGLT2 |
BI 44847 | NCT00558909 | Not yet determined | Phase I | SGLT2 |
EGT0001474 | NCT00924053 | Not yet determined | Phase I | SGLT2 |
GSK-1614235 | NCT01607385 | Not yet determined | Phase I | SGLT1 |
ISIS-SGLT2Rx | NCT00836225 | Not yet determined | Phase I | SGLT2 |
Abbreviations: EMA, European Medicines Agency; FDA, Food and Drug Administration; NA, not applicable; PMDA, Pharmaceuticals and Medical Devices Agency.
Japan; source of information: homepages of the FDA,48 EMA,22 PMDA,49 (www.clinicaltrials.gov).