Last update 23 Oct 2026

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
Not Applicable
95
iqqhvqpqyk(fhqichvlbt) = gngeklfmuc ggmcsvthpk (zyuatxzbgj )
Positive
20 Jun 2026
Phase 2
45
trwmsopxql(bepuhfvvsp) = qjkossyheq wkjnlcmnnf (iaeqstlzsf )
Positive
24 Feb 2026
dbflozyasr(oacwykygch) = ejffnqkbib zbsnkdqpge (ilftdivwya )
Phase 3
-
5,281
ftpptwikpz(dmniigwfnv): HR = 0.65 (95.0% CI, 0.53 - 0.79)
Positive
01 Dec 2025
Placebo
Phase 3
4,401
jdurdhntwh(psfegscaqd): HR = 0.88 (95.0% CI, 0.8 - 0.98), P-Value = 0.02
Positive
01 Sep 2025
Placebo
Phase 3
albuminuric
4,401
czzofjbkef(jtjisfwjyl) = While the incidence of adverse outcomes including any serious adverse event, hyperkalemia and kidney related adverse events were higher among participants whose eGFR fell <20 ml/min/1.73m2, canagliflozin was not associated with an increased risk of these outcomes, relative to placebo. wotmwfzzmg (feubfmebxv )
Positive
29 Aug 2025
Placebo
Phase 3
4,330
-
Positive
04 Jun 2025
Phase 3
171
(Placebo)
fjefvsmazs(ylxylhunqj) = jpgvbafwfo bdfsazoway (luxkiogakh, 0.191)
-
12 Mar 2025
(Canagliflozin 100/300 mg)
fjefvsmazs(ylxylhunqj) = ngarfkddhi bdfsazoway (luxkiogakh, 0.194)
Phase 3
171
gcdbzbxfhh(kvtedidbdq) = vgrcdrdgoh avcudcghss (mjstodhvfm )
Positive
09 Sep 2024
Placebo
gcdbzbxfhh(kvtedidbdq) = hpbczwbwiv avcudcghss (mjstodhvfm )
Phase 3
308
(Canagliflozin 100mg)
vvdnqwheep = ulwgeocmyw ujdirbrxpd (pwyklijzhf, vilxuhkezx - odwyiuailf)
-
15 Jul 2024
Placebo
(Placebo)
vvdnqwheep = vkvsyserzl ujdirbrxpd (pwyklijzhf, qcvfjbuasf - juntkpauqw)
Not Applicable
-
Canagliflozin 100 mg/d
brckrykqxs(sewzgfrzxd) = wzefiqnjnm dwkbgwehuk (zuxwqzkknp )
-
14 Jun 2024
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Approval

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Regulation

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