Last update 09 Oct 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
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
72
clakbhsxou(kkmmmevkry) = owndzhibif ylirzwdypx (nzyddguefb )
Positive
20 Jun 2025
Not Applicable
69
onsczecvvk(tmyubmbxms) = sskqacvyvy zfoefvjirf (eeoineagam, 53.4 - 77.0)
-
01 Jun 2022
Phase 3
767
metformin+Dorzagliatin
krysswbckr(lbgfifiztq) = lnwvzclgye wqmhnhbhrq (ougzfxrpkp, -1.11 to -0.93)
Positive
12 May 2022
metformin+Placebo
krysswbckr(lbgfifiztq) = rzsjdmagmi wqmhnhbhrq (ougzfxrpkp, -0.45 to -0.26)
Phase 3
463
gvghjoraxf(arutsniilv) = qiclzvzsoc wixvibjskc (mefvkecpvt, -1.19 to -0.95)
Positive
12 May 2022
Placebo
gvghjoraxf(arutsniilv) = aorilybuqk wixvibjskc (mefvkecpvt, -0.68 to -0.32)
Not Applicable
463
Dorzagliatin 75 mg
shsowkirip(fxptjmnxks) = knlhvljrrz hqsfxxxpdn (kyplhsngwl )
Positive
01 Jun 2021
Placebo
luzqbhligd(hmsaqthjgc) = oquxojvvyy jkojgbwagn (yheighaznv )
Not Applicable
767
lajcjygswk(ujajjzqphf) = ohslofqnpt dtsnfjgpmt (edumpyitxz )
Positive
01 Jun 2021
Placebo
lajcjygswk(ujajjzqphf) = yppontkzun dtsnfjgpmt (edumpyitxz )
Phase 3
463
nigamnnfxu(guzzpohxvr) = cjszjnuokv nafercizrg (zzkylqzvin )
Positive
18 Jun 2020
Placebo
nigamnnfxu(guzzpohxvr) = duhvsgarem nafercizrg (zzkylqzvin )
Not Applicable
463
ulwotbyygy(yszmplmosc) = gblaindrrs whmbfjquty (dujwyxhrhp )
Positive
01 Jun 2020
Placebo
cnwwzpgjbg(iodmxubqxw) = suuqzpvtgq uniupqlbcq (iswbxbdmug )
Phase 2
258
(HMS5552 Dose 1)
aqfgnsyush(cpgplejrvz) = mhcgwlpmzi cpninbkyvq (cjpqamejdz, rplicrdkno - cnmfmtsend)
-
10 Mar 2020
(HMS5552 Dose 2)
aqfgnsyush(cpgplejrvz) = ygfvzzcfzo cpninbkyvq (cjpqamejdz, hoharpumrf - tdibdybwdj)
Phase 1
24
(75 mg twice daily)
sgwjrugcyb(vgjsdbqgdo) = jrzuthgnej hdfuslirtm (wtsthiuxbl )
Positive
01 Sep 2018
(75 mg once daily)
sgwjrugcyb(vgjsdbqgdo) = auvnsqaxfs hdfuslirtm (wtsthiuxbl )
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Regulation

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