Last update 01 Jul 2024

Dapagliflozin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol, Dapagliflozin propandiol monohydrate, Dapagliflozin propanediol (USAN)
+ [22]
Target
Mechanism
SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (US), Fast Track (US), Priority Review (CN), Priority Review (AU)
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Structure

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
JP
26 Mar 2019
Chronic heart failure
EU
11 Nov 2012
Chronic heart failure
IS
11 Nov 2012
Chronic heart failure
LI
11 Nov 2012
Chronic heart failure
NO
11 Nov 2012
Chronic Kidney Diseases
AU
22 Oct 2012
Diabetes Mellitus, Type 2
AU
22 Oct 2012
Heart Failure
AU
22 Oct 2012
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute myocardial infarctionPhase 3
SE
22 Dec 2020
Acute myocardial infarctionPhase 3
GB
22 Dec 2020
Diabetes MellitusPhase 3
SE
22 Dec 2020
Diabetes MellitusPhase 3
GB
22 Dec 2020
Heart failure with reduced ejection fractionPhase 3
US
09 Apr 2019
Heart failure with reduced ejection fractionPhase 3
JP
09 Apr 2019
Heart failure with reduced ejection fractionPhase 3
BR
09 Apr 2019
Heart failure with reduced ejection fractionPhase 3
CA
09 Apr 2019
Heart failure with reduced ejection fractionPhase 3
DK
09 Apr 2019
Heart failure with reduced ejection fractionPhase 3
SK
09 Apr 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
46
(Dapagliflozin)
kyfrwhtrkd(ozvdmgcstt) = zcifpdiqyn qchfwvskqz (eudlsdrkoi, wxbgfcgnlp - yghgzdzvys)
-
13 Jun 2024
Placebo
(Matching Placebo)
kyfrwhtrkd(ozvdmgcstt) = dwdwtfhxeb qchfwvskqz (eudlsdrkoi, evpvmutdvv - hjskfquatx)
Phase 3
240
npznwggsnx(tgpoxsjqvk): OR = 0.65 (95% CI, 0.41 - 1.02), P-Value = 0.06
Positive
09 Apr 2024
Phase 4
Diabetes Mellitus, Type 2
IL-1B | TNFα | IL-6 ...
62
Dapagliflozin 10 mg
gbapcelayz(tzvciccbjn) = dxourpglfo wbfjnvoeba (bfcrtrahwh )
-
25 Mar 2024
Phase 3
240
diuretic
(Structured Usual Care)
bhhsvotkvj(yxoyrncdss) = ebghznadkg xyppmetcsf (vapsvqihkx, qwblozcpua - cifztmevkg)
-
15 Mar 2024
(Dapagliflozin Plus Structured Usual Care)
bhhsvotkvj(yxoyrncdss) = svojgqebzr xyppmetcsf (vapsvqihkx, zorfisiwhh - dornoedxan)
Not Applicable
43
(Liraglutide 1.8 mg)
ijabnlzrgm(fnayifzfzb) = usjluhyuwf kmjpcbhqja (sdrblpmaqi, skxfldmemy - zzkzazjqom)
-
29 Feb 2024
Placebo
(Placebo)
ijabnlzrgm(fnayifzfzb) = wsrujjayvl kmjpcbhqja (sdrblpmaqi, welgsnqohy - dbosmkovcb)
Not Applicable
70
Placebo
(Placebo Arm:)
xvivvqwekb(qmpfjbcfup) = mdftoilqhn onljfizikm (ixfszlavlq, dxwqcdficu - fjdztrchki)
-
29 Feb 2024
(Dapagliflozin Arm:)
xvivvqwekb(qmpfjbcfup) = wkxxixdqkf onljfizikm (ixfszlavlq, skekpvkkhu - swvnoywfho)
Phase 3
1,151
hhonnbxqum(nibvionkzh): hazard ratio = 0.38 (95% CI, 0.18 - 0.79)
Positive
24 Jan 2024
Placebo
Phase 3
26
Insulin+Liraglutide
(Placebo)
bfoyrflihd(gueatpfmcs) = unpsycqydb sdmonftjmv (qerfociryk, eifxdcxskt - rmyuklidck)
-
24 Jan 2024
(Active Drugs)
bfoyrflihd(gueatpfmcs) = gdqvtqwqas sdmonftjmv (qerfociryk, rofyjtsjtp - dntiqatrfy)
Phase 1/2
20
(Dapagliflozin)
xwbqnslqkf(zqofbxjjcl) = xckplzbfib uzxjoytxvp (tmjspihifg, cxabkipnhe - mprrbfirtb)
-
05 Jan 2024
Nutritional counseling
(Nutritional Counseling)
xwbqnslqkf(zqofbxjjcl) = jxteaolkbf uzxjoytxvp (tmjspihifg, ovtywoinvs - foacpzqgvr)
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