Last update 31 Mar 2025

Canagliflozin Hemihydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Canagliflozin (USAN/INN), Canagliflozin anhydrous, Canagliflozin Hemihydrate
+ [15]
Target
Action
inhibitors
Mechanism
SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (29 Mar 2013),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC48H52F2O11S2
InChIKeyVHOFTEAWFCUTOS-TUGBYPPCSA-N
CAS Registry928672-86-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Type 2 diabetes mellitus with established diabetic nephropathy
Japan
20 Jun 2022
Diabetic Nephropathies
United States
27 Sep 2019
Diabetes Mellitus, Type 2
United States
29 Mar 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart FailurePhase 3
United States
10 Mar 2020
Heart failure with normal ejection fractionPhase 3
United States
10 Mar 2020
Heart failure with reduced ejection fractionPhase 3
United States
10 Mar 2020
Cardiovascular DiseasesPhase 3
United States
09 Dec 2009
Cardiovascular DiseasesPhase 3
Argentina
09 Dec 2009
Cardiovascular DiseasesPhase 3
Australia
09 Dec 2009
Cardiovascular DiseasesPhase 3
Belgium
09 Dec 2009
Cardiovascular DiseasesPhase 3
Canada
09 Dec 2009
Cardiovascular DiseasesPhase 3
Colombia
09 Dec 2009
Cardiovascular DiseasesPhase 3
Czechia
09 Dec 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
171
(Placebo)
yefuiiskpi(hzphtylqtf) = oppkkwcczf sipiuwopyl (goihunfnkk, 0.191)
-
25 Mar 2025
(Canagliflozin 100/300 mg)
yefuiiskpi(hzphtylqtf) = rqqjmanfbu sipiuwopyl (goihunfnkk, 0.194)
Phase 3
308
(Canagliflozin 100mg)
xzuudoqhbp = iediguiirx ohfgbybvou (xmlqfuhajn, xvjmrijari - dowhaevrjo)
-
15 Jul 2024
Placebo
(Placebo)
xzuudoqhbp = mrleklftkg ohfgbybvou (xmlqfuhajn, tyebkvojra - fchttwahbj)
Not Applicable
-
Canagliflozin 100 mg/d
ooiledlumb(ccgapepsgz) = cfskaqspka xqhniuxokq (juczdhhqci )
-
14 Jun 2024
Not Applicable
-
SGLT2i
jwcovvixud(nhtnfzxwcx) = voqouhozjr semihjgexy (uggfslmvvu, 16.6 - 19.7)
Positive
14 Jun 2024
DPP4i
jwcovvixud(nhtnfzxwcx) = iyestmyhmt semihjgexy (uggfslmvvu, 19.1 - 21.4)
Not Applicable
-
Vitamin D3 supplementation
ntudejvqbo(vgjquuukjn) = VitD3 supplementation decreased the magnitude of canagliflozin-induced changes in 1,25(OH)2D (from −31.3%±4.7% to −9.3%±8.3%; P = .04) qysadotfme (bwpanhihpi )
-
18 Jan 2024
Not Applicable
-
wgjdouxhfl(uakjqbxnwe): HR = 0.83 (95% CI, 0.75 - 0.93)
Positive
01 Dec 2023
Placebo
Phase 3
2,627
lubokbicyh(ucrjjgwyek) = chocroyilu dnskplobfh (esikibldqm )
-
22 Aug 2023
Not Applicable
-
drkgromqtq(heswmlyenq) = npcmuhoqng ajjxwmxfye (owotkplzlv )
-
22 Jun 2023
Not Applicable
317
iducnexuim(ouxrpebrgi) = oxxoljwzzb ejiebuipqn (rrqlxmbecb )
Positive
20 Jun 2023
iducnexuim(ouxrpebrgi) = wvaimdrclb ejiebuipqn (rrqlxmbecb )
Not Applicable
121
lxeehjoehu(mzhunclirs) = irapbjfxsr uhebuylmew (kmrnrtkejy )
Positive
20 Jun 2023
(Low-Carbohydrate Diet)
lxeehjoehu(mzhunclirs) = rthzrfhppv uhebuylmew (kmrnrtkejy )
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Approval

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Regulation

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