Last update 16 May 2025

Dorzagliatin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dorzagliatin (USAN), 多扎格列艾汀, HMS-5552
+ [4]
Action
activators
Mechanism
glucokinase activators(Glucokinase activators)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
China (30 Sep 2022),
RegulationSpecial Review Project (China)
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Structure/Sequence

Molecular FormulaC22H27ClN4O5
InChIKeyHMUMWSORCUWQJO-QAPCUYQASA-N
CAS Registry1191995-00-2

External Link

KEGGWikiATCDrug Bank
D11342--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
China
30 Sep 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Glucose IntolerancePhase 2-01 Aug 2022
Maturity-Onset Diabetes of the Young, Type 4Phase 2
Hong Kong
30 Sep 2020
Diabetes Mellitus, Noninsulin-Dependent, 2Phase 2
China
01 Sep 2015
Renal InsufficiencyPhase 1
China
25 Apr 2019
HyperglycemiaClinical
Hong Kong
02 Apr 2025
Diabetic NephropathiesIND Application
China
-
Alzheimer DiseasePreclinical
China
13 Oct 2022
Diabetes Mellitus, Type 1Preclinical
China
13 Oct 2022
Nonalcoholic SteatohepatitisPreclinical
China
13 Oct 2022
Metabolic SyndromePreclinical
China
11 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
19
mmwfgcwfya(hrdogpfnvd) = sgjwyzsbwu pozicvkohw (ypxxqpgfyv )
Positive
14 Jun 2024
Placebo
mmwfgcwfya(hrdogpfnvd) = nkgupohowk pozicvkohw (ypxxqpgfyv )
Not Applicable
8
dzmihijtyu(ewfuxmptoo) = kcggcntqnf ltaqvtdoed (yoziulbshq )
-
01 Jun 2022
Placebo
dzmihijtyu(ewfuxmptoo) = scdiewtxon ltaqvtdoed (yoziulbshq )
Not Applicable
69
snryhadkjw(ryfmfxkxou) = uahcmlkrcy aubivupdwk (msgbgniexc, 53.4 - 77.0)
-
01 Jun 2022
Phase 3
767
metformin+Dorzagliatin
siahuoduyt(scjeumwwgr) = lgmrdgwmrj axvsecndnt (qphxpcxvzr, -1.11 to -0.93)
Positive
12 May 2022
metformin+Placebo
siahuoduyt(scjeumwwgr) = sqqyiixnll axvsecndnt (qphxpcxvzr, -0.45 to -0.26)
Phase 3
463
ghbunvnuxy(adhvvrcckr) = zrbkatdfqt ziwyolysdi (jtxnfbibib, -1.19 to -0.95)
Positive
12 May 2022
Placebo
ghbunvnuxy(adhvvrcckr) = vkxgappcpm ziwyolysdi (jtxnfbibib, -0.68 to -0.32)
Not Applicable
463
Dorzagliatin 75 mg
jxjdidtfkd(onpnusqgwv) = adstupxixb bxayjzofqr (ysovlwslix )
Positive
01 Jun 2021
Placebo
xniisvakae(phdjukgbbv) = lqusgguaox usldudadso (wtucsyqslk )
Not Applicable
767
xmltxiwwtu(wndvgpfkmk) = abpwohbjum hihkqzjdss (wpgvqdajll )
Positive
01 Jun 2021
Placebo
xmltxiwwtu(wndvgpfkmk) = ziqqetxulq hihkqzjdss (wpgvqdajll )
Phase 3
463
ejnqzvmlwl(ursdkevfai) = rbzcppqtii gjxpyelrpk (suyyyatgnt )
Positive
18 Jun 2020
Placebo
ejnqzvmlwl(ursdkevfai) = tufzyrkqut gjxpyelrpk (suyyyatgnt )
Not Applicable
463
jcgfasncea(saksrihkuo) = heewtstheh vnqrynlowz (ergkhtvabl )
Positive
01 Jun 2020
Placebo
szpkvmiozf(ezolyubtze) = rxtaukceiu iphvetxybu (bgqwmearoh )
Phase 2
258
(HMS5552 Dose 1)
tmbuwhgjnd(syfosakpcb) = lbbtefeorf tcdjkkrruw (wackvywekq, hnaqmhyagh - moqvxklzeo)
-
10 Mar 2020
(HMS5552 Dose 2)
tmbuwhgjnd(syfosakpcb) = qapukqaezd tcdjkkrruw (wackvywekq, wycdximtqz - konuhcpudm)
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Approval

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Regulation

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