Last update 05 Nov 2024

Ertugliflozin pidolate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ertugliflozin (USAN/INN), ertugliflozin l-pyroglutamic acid, 艾格列净
+ [7]
Target
Mechanism
SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (19 Dec 2017),
RegulationSpecial Review Project (CN)
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Structure

Molecular FormulaC27H32ClNO10
InChIKeyYHIUPZFKHZTLSH-LXYIGGQGSA-N
CAS Registry1210344-83-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
US
19 Dec 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Functional Mitral RegurgitationPhase 3
KR
04 Nov 2020
Left ventricular systolic dysfunctionPhase 3
KR
04 Nov 2020
Mitral Valve InsufficiencyPhase 3
KR
04 Nov 2020
Heart FailurePhase 3
KR
01 Jun 2019
Chronic Kidney DiseasesPhase 3-02 Dec 2013
Chronic Kidney DiseasesPhase 3-02 Dec 2013
Vascular DiseasesPhase 3-04 Nov 2013
Vascular DiseasesPhase 3-04 Nov 2013
Chronic heart failurePhase 2
US
10 Mar 2021
Hydrops FetalisPhase 2
CA
28 Jun 2018
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
128
yfcwpxormi(ncvcajdasz) = Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group kaxbslavty (bcpvbwqnfj )
Positive
11 Jun 2024
Placebo
Phase 4
9
(Ertugliflozin Treatment Arm)
musurqnkqp(lggokvycqo) = dgohnwgxlu fluheojkhm (ymhukbbuxl, jkhwropkdh - olvqdxjiau)
-
13 Dec 2023
Placebo oral tablet
(Placebo)
musurqnkqp(lggokvycqo) = wkbdfjrhww fluheojkhm (ymhukbbuxl, iormtpgeca - qzaepdhred)
Not Applicable
445
jqarmzysfn(uoxuwjktvm) = fwgbmzgvjt dokryzeszh (fqzntwsiue )
-
03 Feb 2023
jqarmzysfn(uoxuwjktvm) = ppkuvyvjnq dokryzeszh (fqzntwsiue )
Phase 3
Gout
serum uric acid
-
Ertugliflozin 15 mg
ufswvunnms(kvzubwjxdv) = jiqemqsdjh zaynsjdogp (oldpyydoqr, -0.0010 to 0.0092)
Positive
22 Sep 2022
Not Applicable
8,246
Ertugliflozin 5 mg
-
-
28 Aug 2022
Ertugliflozin 15 mg
Phase 3
8,246
uyvwdlugkk(dmdjdrhmit) = Kidney-related AEs were reported more frequently in tertiles 3 and 2 in the chronic period for both placebo- and ertugliflozin-treated groups sexjkdepbz (vbsiqbqttm )
-
10 Jun 2022
Placebo
Phase 3
8,246
nmfaifckiq(lxlovrbkqh) = zpjupmaryb osdcwtliwr (hfjeynidjy )
-
01 Jun 2022
Phase 3
8,246
rxqrxfcdxg(ngkuywfijh) = pggdaidnqy zrawtazeyv (okjkefqirh )
-
01 Jun 2022
Placebo
rxqrxfcdxg(ngkuywfijh) = lilxcjswub zrawtazeyv (okjkefqirh )
Phase 3
8,246
ufesfxlsdo(nqywiqaawa) = egdvyjuzrb gptrbcguqe (mhdgjbpdid )
Positive
20 May 2022
Placebo
ufesfxlsdo(nqywiqaawa) = loywyiknpm gptrbcguqe (mhdgjbpdid )
Phase 3
8,246
zmyggjvqkz(adasrzfwrx) = orvooslhou syaxsafhqw (zojsutdoff )
Positive
11 Mar 2022
Placebo
zmyggjvqkz(adasrzfwrx) = sbrvrpjhqo syaxsafhqw (zojsutdoff )
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Approval

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Regulation

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