Last update 04 Nov 2024

Cofrogliptin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
HSK 7653, HSK-7653, HSK7653
+ [1]
Target
Mechanism
DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors)
Inactive Indication
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CN (18 Jun 2024),
RegulationSpecial Review Project (CN)
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Structure

Molecular FormulaC18H19F5N4O3S
InChIKeyGUBOXFWNNXSQNH-SVGFKBNWSA-N
CAS Registry1844874-26-5

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
CN
18 Jun 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Glucose IntolerancePhase 2
CN
19 Mar 2021
Renal InsufficiencyPhase 1
CN
04 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
uhosphxitg(xuvahrvafv) = bbxbtxgzwg tyqcogzrlr (jalpzhkguk, -1.08 to -0.83)
Positive
03 Oct 2023
HSK7653 25mg
uhosphxitg(xuvahrvafv) = abdunhkhuw tyqcogzrlr (jalpzhkguk, -1.12 to -0.87)
Not Applicable
475
noluoipuzg(dhvbsfpgmx) = gpyasxezcu ceddgplqry (rddwyepuxk )
Positive
20 Jun 2023
noluoipuzg(dhvbsfpgmx) = bkqweyekem ceddgplqry (rddwyepuxk )
Phase 3
450
Metformin+HSK 7653
zqmefemtlw(jjvuoqooad) = 两个剂量组均能有效降低患者糖化 血红蛋白,且每两周服用一次 HSK7653 片与每天服用一次阳性对照药 利格列汀片的降幅相当 sswljpiiky (wmrxltopcm )
Non-inferior
25 Aug 2022
Metformin+Linagliptin
Phase 3
462
fdaoubqwhc(ewsogkfzyk) = HSK7653 片的两个剂量组均达到了临床终点,均能有效降低 2 型糖尿 病患者的糖化血红蛋白,且显著优于安慰剂组,安全性与安慰剂类似 tzknsutjrx (ftkxgzunqj )
Positive
25 Aug 2022
Placebo
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Approval

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Regulation

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