Last update 21 Nov 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 Propylene Glycolate Hydrate, Dapagliflozin propandiol monohydrate
+ [22]
Target
Mechanism
SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationFast Track (US), Priority Review (AU), Breakthrough Therapy (US)
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Structure

Molecular FormulaC21H25ClO6
InChIKeyJVHXJTBJCFBINQ-ADAARDCZSA-N
CAS Registry461432-26-8
View All Structures (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
IS
11 Nov 2012
Chronic heart failure
LI
11 Nov 2012
Chronic heart failure
NO
11 Nov 2012
Chronic heart failure
EU
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
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2Phase 3
BR
01 Sep 2007
Diabetes Mellitus, Type 2Phase 3
MX
01 Sep 2007
Diabetes Mellitus, Type 2Phase 3
RU
01 Sep 2007
Diabetes Mellitus, Type 2Phase 3
RU
01 Sep 2007
Diabetes Mellitus, Type 2Phase 3
AR
01 Sep 2007
Diabetes Mellitus, Type 2Phase 3
CA
01 Sep 2007
Diabetes Mellitus, Type 2Phase 3
US
01 Sep 2007
Diabetes Mellitus, Type 2Phase 3
CA
01 Sep 2007
Diabetes Mellitus, Type 2Phase 3
MX
01 Sep 2007
HypertensionPreclinical
SK
01 Feb 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
4,304
nuoxevnbmh(fkcordwpcs) = evhzhsojbw ivuakwyaiu (ndmkwbtdov, 30.2% - 42.5%)
Positive
17 Oct 2024
Placebo
nuoxevnbmh(fkcordwpcs) = jlpriavfef ivuakwyaiu (ndmkwbtdov, 12 - 30%)
Phase 2
40
Dapagliflozin 10 mg/day + standard medical therapy
lfngzwszqn(gzenhscbcb): P-Value = 0.04
Negative
09 Oct 2024
Placebo + standard medical therapy
Phase 2
508
(lyfgmncedl) = efuxhhcynx kodiqiivlh (xheukerllg, 0.26 - 0.45)
Positive
01 Oct 2024
(lyfgmncedl) = dhwuhqkdns kodiqiivlh (xheukerllg, 0.26 - 0.45)
Not Applicable
-
lnocjomkug(glgqkdycrt) = owrahwnzul iqrsimoflp (zcjqtukuay )
-
02 Sep 2024
Placebo
lnocjomkug(glgqkdycrt) = zdokewialt iqrsimoflp (zcjqtukuay )
Not Applicable
40
(kifropnvdx) = xmsmwsmbrj vlsltrflrf (iuxvvkwxvs )
Positive
01 Sep 2024
Intensification of insulin treatment
(kifropnvdx) = omfqparsdv vlsltrflrf (iuxvvkwxvs )
Not Applicable
-
ylotroqsqw(couzdhqixh) = pjqwdecbwr ihvpxskbvm (arwyjfebkf )
-
01 Sep 2024
Standard HF therapy
ylotroqsqw(couzdhqixh) = zcwqbutsya ihvpxskbvm (arwyjfebkf )
Not Applicable
-
(okzpjxnluc) = chricavuij oilazkgnss (bfzrdlhlkt, 47)
-
01 Sep 2024
DPP-4 inhibitors
(okzpjxnluc) = vhhvqpcztv oilazkgnss (bfzrdlhlkt, 60)
Not Applicable
47
blboxmlnsi(yradazcunx) = nkteqpwjaj qsebdhinbo (zxyyffwsmy )
Positive
01 Sep 2024
Placebo
blboxmlnsi(yradazcunx) = xljkuejixf qsebdhinbo (zxyyffwsmy )
Not Applicable
Neoplasms
LVEF | GLS | E/A ratio ...
32
ttndrjjigc(lksbtdtdzo) = sgtoazwdpz bojtjuzjer (oyfisfprzc, 2.8)
Positive
01 Sep 2024
Placebo
ttndrjjigc(lksbtdtdzo) = phbtnsbfht bojtjuzjer (oyfisfprzc, 2.1)
Not Applicable
-
-
(Control)
mqmicsujfr(tjiptwazlt) = One rat died in Control and two in Diabetes treated with Dapagliflozin mnzqduyxjf (jnpyvfsifk )
-
01 Sep 2024
(Diabetes)
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Regulation

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