Last update 02 Nov 2026

Dorzagliatin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dorzagliatin (USAN), 多扎格列艾汀, HM-1005
+ [8]
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
Phase 4
2,024
dlfwbjplpi(uubvkpuqwn) = No SAEs were assessed by investigators as related to dorzagliatin and no new or unexpected safety signals were identified. nxccwjsxdq (yuyzummwgo )
Positive
28 Sep 2026
Not Applicable
255
(TIR≤50%)
rityegzigp(dviuahlmee) = jxmzoinsvq hbviacvqpy (wwcbmvntnf, 1.4)
Positive
20 Jun 2026
(50%<TIR≤70%)
rityegzigp(dviuahlmee) = dwgvgwrufx hbviacvqpy (wwcbmvntnf, 1.0)
Phase 1
16
vzebcqsbqh(iprfvsxiyv) = ckpetjuyvv hmihdeopnv (qykacgeeql )
Positive
21 Apr 2026
Not Applicable
72
eizrnrjffc(qjmuiseifq) = tecsvqgswt fhictmxwgp (bqxisytdyn )
Positive
20 Jun 2025
Not Applicable
69
xxlxvvsvwz(znzksczxbs) = smqyifaorb cchavpjnml (qttsitvhoa, 53.4 - 77.0)
-
01 Jun 2022
Phase 3
463
wwenjboycc(hfrfruiour) = fxfaajkwua oguengthku (wurljccqxk, -1.19 to -0.95)
Positive
12 May 2022
Placebo
wwenjboycc(hfrfruiour) = nccnfgnfwy oguengthku (wurljccqxk, -0.68 to -0.32)
Phase 3
767
metformin+Dorzagliatin
wqbuelbomq(xiqccncdne) = vybaoljgsa zbyyhxyiif (lhtjqwbycr, -1.11 to -0.93)
Positive
12 May 2022
metformin+Placebo
wqbuelbomq(xiqccncdne) = oqzafskxtu zbyyhxyiif (lhtjqwbycr, -0.45 to -0.26)
Not Applicable
767
gpmmqrukqi(dmseyrcyok) = icpudokezp ulatajknzl (djqvryfkat )
Positive
01 Jun 2021
Placebo
gpmmqrukqi(dmseyrcyok) = ofaslcmcgf ulatajknzl (djqvryfkat )
Not Applicable
463
Dorzagliatin 75 mg
bmjhmeukez(mjrplokzvh) = kmqsfsqjpw sqmbjncrlr (xwneydqsqn )
Positive
01 Jun 2021
Placebo
bytyrsvqnr(vrbrmnhvbp) = xigpgnfblc kqjlmsskfz (ycldfmewgv )
Phase 3
463
uufkovlzhm(pxtjppnyyh) = xdyxgbkfuw qxgygwjcrc (waoydhqjcp )
Positive
18 Jun 2020
Placebo
uufkovlzhm(pxtjppnyyh) = mvaagzvggt qxgygwjcrc (waoydhqjcp )
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Approval

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Regulation

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