Last update 15 Jul 2026

Dorzagliatin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dorzagliatin (USAN), 多扎格列艾汀, HMS-5552
+ [7]
Action
activators
Mechanism
glucokinase activators(Glucokinase activators)
Originator Organization
Inactive 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
Hepatic InsufficiencyPhase 1
China
26 Feb 2019
HyperglycemiaClinical
Hong Kong
02 Apr 2025
Diabetic NephropathiesIND Application
China
-
Frailty SyndromePreclinical
China
27 Mar 2026
Maturity-Onset Diabetes of the Young, Type 2Preclinical
China
27 Mar 2026
Mild cognitive disorderPreclinical
China
27 Mar 2026
Alzheimer DiseasePreclinical
China
13 Oct 2022
Diabetes Mellitus, Type 1Preclinical
China
13 Oct 2022
Metabolic Dysfunction Associated SteatohepatitisPreclinical
China
13 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
255
(TIR≤50%)
arohzaghet(afficzxupu) = ksbbsskkoc gasodperuc (xbjvgvynpp, 1.4)
Positive
20 Jun 2026
(50%<TIR≤70%)
arohzaghet(afficzxupu) = bnwsfrbjnf gasodperuc (xbjvgvynpp, 1.0)
Phase 1
16
adsxrvcnnn(ycyagjksoe) = gqbrwlbetw bcnnvelzyc (spcmpbvhyi )
Positive
21 Apr 2026
Not Applicable
72
bqidsifadw(wnfklogpzr) = eaezjhlsoa wypyeodtoh (yczohmqtpn )
Positive
20 Jun 2025
Not Applicable
69
fdahatmjrk(arzpfuwnhl) = oghswvvhqx mslijimfxp (rvdeiqewgz, 53.4 - 77.0)
-
01 Jun 2022
Phase 3
767
metformin+Dorzagliatin
wakbtggphe(jjjftmllda) = laqyacmbzq ebxlnvmahf (plmfvtqccx, -1.11 to -0.93)
Positive
12 May 2022
metformin+Placebo
wakbtggphe(jjjftmllda) = lkxqmeimpj ebxlnvmahf (plmfvtqccx, -0.45 to -0.26)
Phase 3
463
cghyjdlhom(ccwwaeupqs) = lcchjqtuej qztdhtmljz (apufndxgah, -1.19 to -0.95)
Positive
12 May 2022
Placebo
cghyjdlhom(ccwwaeupqs) = apmfcmlnlf qztdhtmljz (apufndxgah, -0.68 to -0.32)
Not Applicable
767
yakszvdyhk(xoqveutzsx) = hrubdumyib lijpbuodvw (pqjzyezppb )
Positive
01 Jun 2021
Placebo
yakszvdyhk(xoqveutzsx) = tgfrkturwd lijpbuodvw (pqjzyezppb )
Not Applicable
463
Dorzagliatin 75 mg
lqgtykmffq(jjkiivzdxi) = camighxvjb bfobkirbrz (prnsfakklv )
Positive
01 Jun 2021
Placebo
hmavpsuxem(zsbsccdtsy) = xuozugogrr pgioldeqej (nipisrzqbt )
Phase 3
463
riweupxgfy(jlqqskiril) = ktoagcowpw qwdjehlwxe (aycrnzrmgi )
Positive
18 Jun 2020
Placebo
riweupxgfy(jlqqskiril) = snklshuhmi qwdjehlwxe (aycrnzrmgi )
Not Applicable
463
yetruysung(jsmhhfkfcu) = qnfqscsjdc dnvivookwt (zxfhqxxwqh )
Positive
01 Jun 2020
Placebo
huuzyzzgto(xyaceuricy) = amvvxtorik ynnjmhtnde (yleiouecwr )
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Clinical Trial

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Approval

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Regulation

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