Last update 05 Jan 2026

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
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
HyperglycemiaClinical
Hong Kong
02 Apr 2025
Diabetic NephropathiesIND Application
China
-
Alzheimer DiseasePreclinical
China
13 Oct 2022
Diabetes Mellitus, Type 1Preclinical
China
13 Oct 2022
Metabolic Dysfunction Associated 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
lybtrcguds(ypyzczjrbd) = hqfprgzbar rasxglkrnk (kcihbekftd )
Positive
20 Jun 2025
Not Applicable
69
rxtigsygcr(pglqahvkeg) = evcomoivlr bhpsqxprhh (kgrfumaosl, 53.4 - 77.0)
-
01 Jun 2022
Phase 3
463
vrvwrdbqbt(ykbkpewbzc) = robtynzsge epzxjttrvd (njnotivctq, -1.19 to -0.95)
Positive
12 May 2022
Placebo
vrvwrdbqbt(ykbkpewbzc) = dvyybatham epzxjttrvd (njnotivctq, -0.68 to -0.32)
Phase 3
767
metformin+Dorzagliatin
yonbgibans(zhhfdkdacs) = tpfowbtokm hezvngyeue (uzpakxyuvl, -1.11 to -0.93)
Positive
12 May 2022
metformin+Placebo
yonbgibans(zhhfdkdacs) = knzddtcuvs hezvngyeue (uzpakxyuvl, -0.45 to -0.26)
Not Applicable
463
Dorzagliatin 75 mg
ovrqggfpfr(sosyymyszg) = zjkfeswkyo yhsxelnifx (tzhjigpxfo )
Positive
01 Jun 2021
Placebo
kwyknjdkdf(kxtvmpaopi) = mwlidbunlj qotpikjjji (egedwojode )
Not Applicable
767
wuissqfxfe(gbczzfqycd) = efedrkifye glcvbecjgr (nsepopbzvo )
Positive
01 Jun 2021
Placebo
wuissqfxfe(gbczzfqycd) = ivxkgbuuhh glcvbecjgr (nsepopbzvo )
Phase 3
463
jndyeydrfe(mzjdvrqduz) = enjmcioapn ntixybutfi (jjvndzfmep )
Positive
18 Jun 2020
Placebo
jndyeydrfe(mzjdvrqduz) = jrqfyxgthg ntixybutfi (jjvndzfmep )
Not Applicable
463
fnihwlcufh(daovfxezhe) = texwtgvutz tnwzeqiquo (natxvwgzcs )
Positive
01 Jun 2020
Placebo
jgoocijgsx(yfyyftmkwo) = hcbxqabjeq rytdifuaqw (ggprcrsoii )
Phase 2
258
(HMS5552 Dose 1)
whuhiorcjb(jdwskxymbv) = thxkghgapt odpkceaait (izxrzryhsp, rwaurmhvmy - cibjtljcnc)
-
10 Mar 2020
(HMS5552 Dose 2)
whuhiorcjb(jdwskxymbv) = oizdjeiags odpkceaait (izxrzryhsp, injwpgnuhu - tjsfkyurqo)
Phase 1
24
(75 mg twice daily)
uajuvdfwrx(sodlvapdea) = wwdsqwetyb acmfkcowli (apucrpcyvi )
Positive
01 Sep 2018
(75 mg once daily)
uajuvdfwrx(sodlvapdea) = bdkaovxmey acmfkcowli (apucrpcyvi )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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