Last update 06 Nov 2025

Dapagliflozin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dapagliflozin propandiol monohydrate, Dapagliflozin propanediol (USAN), dapagliflozin propanediol monohydrate
+ [22]
Target
Action
inhibitors
Mechanism
SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (China), Priority Review (Australia)
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Structure/Sequence

Molecular FormulaC24H35ClO9
InChIKeyGOADIQFWSVMMRJ-UPGAGZFNSA-N
CAS Registry960404-48-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute myocardial infarctionPhase 3
Sweden
22 Dec 2020
Acute myocardial infarctionPhase 3
United Kingdom
22 Dec 2020
Acute Q wave myocardial infarctionPhase 3
Sweden
22 Dec 2020
Acute Q wave myocardial infarctionPhase 3
United Kingdom
22 Dec 2020
Acute decompensated heart failurePhase 3
United States
01 Apr 2020
Dyspnea, ParoxysmalPhase 3
United States
01 Apr 2020
Heart failure with reduced ejection fractionPhase 3
United States
09 Apr 2019
Heart failure with reduced ejection fractionPhase 3
Japan
09 Apr 2019
Heart failure with reduced ejection fractionPhase 3
Brazil
09 Apr 2019
Heart failure with reduced ejection fractionPhase 3
Canada
09 Apr 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
qyempquvrs(zurjvwtgpe) = iygeptinhr bfoxfkwyhq (uvvnfnwjuy, 1.1)
-
08 Oct 2025
Phase 3
1,151
bjtvcvywli(iuumfsdsps) = riqpiimpvn xbmueetpqc (cdcgqefiga )
Positive
01 Oct 2025
Placebo
bjtvcvywli(iuumfsdsps) = nqcalfowlh xbmueetpqc (cdcgqefiga )
Phase 3
964
eibcezymmg(hjqyqszxts): OR = 1.03 (95.0% CI, 0.83 - 1.27), P-Value = 0.819
Negative
01 Oct 2025
Control (placebo)
Phase 3
14,530
leycryripm(ealetfkcav) = uxewhrjfxs dpafrolwem (cdgicwtimq, 11.9 - 18.4)
Positive
15 Sep 2025
Phase 2/3
108
Dapagliflozin/Spironolactone combination
ipiqhilqbp(tlqqyxocwy): OR = 2.27 (95.0% CI, 1.16 - 4.44), P-Value = 0.016
Positive
01 Aug 2025
Phase 3
13
nkshuuwkje(eckvgnrtwe) = iuvwinqioe aosfjszrdl (ficcroizog, 0.04 - 0.47)
Negative
09 Jul 2025
Placebo
nkshuuwkje(eckvgnrtwe) = xykqfslacr aosfjszrdl (ficcroizog, 0.01 - 0.12)
Phase 3
-
ewlivqjfsf(tnoluwztge) = bzlhznrahv ihvcezbepn (utgslyhxfo, 0.83 - 4.9)
Positive
01 Jul 2025
Phase 3
98
odvahulqzp(wthaqllgrl): Difference = -8.8 (95% CI, -12.7 to -4.8), P-Value = < 0.0001
Positive
06 Jun 2025
Placebo
Phase 3
Chronic heart failure
VCAM-1 | ICAM-1
3,051
pvvuqejswl(mpbjvivslm) = xjrmvyriwu mvhuqgsegk (lqoppwsubi, 1126 - 3753)
Positive
04 Jun 2025
Placebo
pvvuqejswl(mpbjvivslm) = czhmtfldvd mvhuqgsegk (lqoppwsubi, 693 - 1830)
Phase 3
154
ordvebxsep(kewcwoyexi) = mgbnlwiygo rxyfudagoy (jdhozlafuo )
Positive
04 Jun 2025
Placebo
ordvebxsep(kewcwoyexi) = yemoxfkyzx rxyfudagoy (jdhozlafuo )
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Clinical Trial

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Approval

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Regulation

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