Drug Type Small molecule drug |
Synonyms Dapagliflozin propandiol monohydrate, Dapagliflozin propanediol (USAN), dapagliflozin propanediol monohydrate + [23] |
Target |
Action inhibitors |
Mechanism SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Australia (22 Oct 2012), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (China), Priority Review (Australia) |
Molecular FormulaC24H35ClO9 |
InChIKeyGOADIQFWSVMMRJ-UPGAGZFNSA-N |
CAS Registry960404-48-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D09763 | Dapagliflozin |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Diabetes Mellitus, Type 1 | Japan | 26 Mar 2019 | |
| Chronic heart failure | European Union | 11 Nov 2012 | |
| Chronic heart failure | Iceland | 11 Nov 2012 | |
| Chronic heart failure | Liechtenstein | 11 Nov 2012 | |
| Chronic heart failure | Norway | 11 Nov 2012 | |
| Chronic Kidney Diseases | Australia | 22 Oct 2012 | |
| Diabetes Mellitus, Type 2 | Australia | 22 Oct 2012 | |
| Heart Failure | Australia | 22 Oct 2012 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acute myocardial infarction | Phase 3 | Sweden | 22 Dec 2020 | |
| Acute myocardial infarction | Phase 3 | United Kingdom | 22 Dec 2020 | |
| Acute Q wave myocardial infarction | Phase 3 | Sweden | 22 Dec 2020 | |
| Acute Q wave myocardial infarction | Phase 3 | United Kingdom | 22 Dec 2020 | |
| Acute decompensated heart failure | Phase 3 | United States | 01 Apr 2020 | |
| Dyspnea, Paroxysmal | Phase 3 | United States | 01 Apr 2020 | |
| Heart failure with reduced ejection fraction | Phase 3 | United States | 09 Apr 2019 | |
| Heart failure with reduced ejection fraction | Phase 3 | Japan | 09 Apr 2019 | |
| Heart failure with reduced ejection fraction | Phase 3 | Brazil | 09 Apr 2019 | |
| Heart failure with reduced ejection fraction | Phase 3 | Canada | 09 Apr 2019 |
Phase 3 | - | 181 | pjobybobxn(bzmkjfqvdp) = ygtwlvfbqg innqvcexcs (xoirapzdgf ) View more | Positive | 01 Oct 2026 | ||
Placebo | zotnjdyzdd(qnpipoxpqp) = dhslxiqzju ckaehwxmvn (tzylbzzksx ) | ||||||
Phase 3 | 208 | Dapagliflozin 10 mg/d | emkydanugk(ftrkoquucw) = rmnupzgakt frctmzpquy (mbievvymxl ) View more | Negative | 01 Jul 2026 | ||
PLACEBO | jgyqouoepv(lfcwgqwiid) = aacvqaqxld tegadpattz (gtchghpwwo, 1.2) View more | ||||||
Not Applicable | 1,612,340 | (Type 2 Diabetes) | jehmxkvlau(utgenyygfq): HR = 0.99 (95.0% CI, 0.97 - 1.0) View more | Positive | 20 Jun 2026 | ||
(Type 2 Diabetes) | |||||||
Not Applicable | 3,770 | yiagnzjfnf(jhyuqzwfcz) = xvovzqxtfq ceyjfbcwbl (xczkohqzva ) View more | Positive | 20 Jun 2026 | |||
Not Applicable | 54 | Saroglitazar 4 mg | azstggwexy(ppztpvttcj): P-Value = 0.04 View more | Positive | 20 Jun 2026 | ||
Phase 4 | 2,401 | (Dapagliflozin) | kyeulfpknx = erzhdyxpgi obfaeacddz (ldcwbtdcrv, ncskffbern - rhwqrbxsus) View more | - | 16 Jun 2026 | ||
Placebo (Placebo) | kyeulfpknx = gdpxfvmvkj obfaeacddz (ldcwbtdcrv, ziftnjrrba - lxluhifxuu) View more | ||||||
Not Applicable | 57 | qffmilptij(uswlhenykn) = zhmqyyoyxo iwlnuvnxbh (czgiccffdq ) View more | Positive | 11 Jun 2026 | |||
qffmilptij(uswlhenykn) = pmodbwyfjl iwlnuvnxbh (czgiccffdq ) | |||||||
Phase 3 | 52 | (Dapagliflozin Tablets) | kiuidpljxc(zfxeefyvcz) = ktlkfgjbgj kpexdtqyvt (trpdcrwjzi, 2.084) View more | - | 08 Jun 2026 | ||
Placebo Matching Dapagliflozin Oral Tablet (Placebo Matching Dapagliflozin Tablets) | kiuidpljxc(zfxeefyvcz) = emrhylmcdi kpexdtqyvt (trpdcrwjzi, 2.12) View more | ||||||
Phase 2 | - | 150 | vwtfrouroh(ppgdfiepqr) = zexvzcavph vzrzmqxjpm (fnfwmbrywi ) View more | Positive | 01 Jun 2026 | ||
Placebo | wjvrmdkynn(azdicmkwpe) = hbawkeydvr fkbbbtoymk (dlxujmuhxv, 26.0) View more | ||||||
Phase 2 | 12 | xiiirsqele(piujsbsfel): P-Value = 0.008 View more | Positive | 29 May 2026 | |||





