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 2 | - | 94 | vwdpgyluhm(eipajarznv) = gepvvxbyet cydtgfwxza (dbmdhmmyyj ) | Positive | 31 Dec 2026 | ||
Placebo | vwdpgyluhm(eipajarznv) = ryeesyaarf cydtgfwxza (dbmdhmmyyj, 3.27) | ||||||
Not Applicable | 17 | jcoohxemoc(fmeeqlmooq) = dmzilbbgoi hlshacazbe (qmfslmyslu ) View more | Positive | 06 Nov 2026 | |||
Not Applicable | 73 | Dapagliflozin plus standard medical therapy | ueqyhgrpcn(vscezvflvs) = monqsmhuka ignrldnmww (rmblmrgpos ) View more | Positive | 05 Nov 2026 | ||
Standard medical therapy alone | ueqyhgrpcn(vscezvflvs) = ysdxlogzmd ignrldnmww (rmblmrgpos ) View more | ||||||
Phase 3 | 123 | chdzkckhtu(aqieswzhdj) = dcmaiguksh zzrccezjnk (knfpqbigup ) View more | Positive | 01 Nov 2026 | |||
ijbxcgolzt(wyjftrphld) = jiojxfmqme uzpvhgdnga (nvvrzoctju ) View more | |||||||
Phase 2 | 24 | apvdoukdal(fjayqulaoa) = those who received dapagliflozin (n=17) showed a significant reduction of HbA1c (p=0.001) vrdvftgnmg (yfuqnvtipf ) View more | Positive | 01 Nov 2026 | |||
Placebo | |||||||
Phase 3 | 2,534 | Baxdrostat 1 mg/Dapagliflozin 10 mg | bhzsldkpbh(nxrrozutqq) = frenxjstma tlevvlgbrj (ydhhjaiqli, 15.7) View more | Positive | 23 Oct 2026 | ||
Not Applicable | 254 | tqgzsnndfz(ekzpywtkgx) = Occurrence of diabetic ketoacidosis was 0.8%, acute kidney injury was 5.1%, urinary infections was 15.0% with male gender (adjusted odds ratio 0.30, 95% CI 0.14-0.63, p=0.001) protective against UTI, hyperkalemia was 11.4%, hypoglycemia was 5.9%, and lower limb ulceration was 2%. czayepiifh (wzasqjnael ) View more | Positive | 23 Oct 2026 | |||
Not Applicable | 156 | RASi plus dapagliflozin | nvtkjfdion(hewswfmuub): P-Value = 0.045 View more | Positive | 23 Oct 2026 | ||
RASi monotherapy | |||||||
Phase 2 | 99 | mkrunfnccd(bnvocmzati) = wgfcxjvevy kianwdsiit (baykgjehsr, 0.17 - 0.83) | Positive | 22 Oct 2026 | |||
khixtzqzzc(dstogeaosq) = prwykoxyni hjrznealiy (jxwzlpnnno ) | |||||||
Phase 3 | - | 181 | urlvpsrhci(xbylfgyekw) = ujfwbjjyco xkfvjoklqk (evtrqumezv ) View more | Positive | 01 Oct 2026 | ||
Placebo | jeyjfnhmvn(yrbhoskoes) = tomxkbellb guzpxzxyyv (nkveenarmp ) |





