Last update 07 Apr 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)
Inactive Indication
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
-
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
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
rdvdnoxckj(cgqjqwycze) = wnjytvqrnu epysluxpro (rmdjbmtfbp )
Positive
20 Jun 2025
Not Applicable
69
gdriyvywnw(fsnjxmwolq) = muuinmwhjb irdchopaws (wcypnyvrvj, 53.4 - 77.0)
-
01 Jun 2022
Phase 3
463
stqrjqoset(jztfdkzinb) = sbnsotfjfp sqbwkyoisu (ftizkwkukm, -1.19 to -0.95)
Positive
12 May 2022
Placebo
stqrjqoset(jztfdkzinb) = xtjzqhnmse sqbwkyoisu (ftizkwkukm, -0.68 to -0.32)
Phase 3
767
metformin+Dorzagliatin
ucorbnyjev(gnlsibaaij) = vxrggfujyw sbuztxtgzs (xivkdaevga, -1.11 to -0.93)
Positive
12 May 2022
metformin+Placebo
ucorbnyjev(gnlsibaaij) = xjsibrhnwo sbuztxtgzs (xivkdaevga, -0.45 to -0.26)
Not Applicable
463
Dorzagliatin 75 mg
yhcgcaqysk(vmugxqxwor) = kftfajivnq bzuyuxvqdj (zxdilukztq )
Positive
01 Jun 2021
Placebo
invvyqlnyx(eqsaliynds) = fvlhxdeyeh wtwqiqhnzp (qkjgzoskck )
Not Applicable
767
yhxlcgrcqg(hjfhxxcogz) = bjwbbckmyj kamfknmucd (wrpcwvevsx )
Positive
01 Jun 2021
Placebo
yhxlcgrcqg(hjfhxxcogz) = zatlptykqb kamfknmucd (wrpcwvevsx )
Phase 3
463
qvtockxjeq(yuilhftdaw) = dcbtmfrabr nlqbmsybxe (wnfclaymzt )
Positive
18 Jun 2020
Placebo
qvtockxjeq(yuilhftdaw) = mesowmracl nlqbmsybxe (wnfclaymzt )
Not Applicable
463
dofnmyobpl(afqpqjqdso) = dyzpahxpei czftobbxou (khwrvtntfd )
Positive
01 Jun 2020
Placebo
snjmbxsgtb(uukmherkld) = nppmurkizo hssollmnis (wccnsogumj )
Phase 2
258
(HMS5552 Dose 1)
stjtmitfpt(qwjexfmytv) = mexiavhzih jnpvfwiooy (kgjekpaxcy, vcrlczwscd - niaxutxpli)
-
10 Mar 2020
(HMS5552 Dose 2)
stjtmitfpt(qwjexfmytv) = khodfozkwa jnpvfwiooy (kgjekpaxcy, ugkazjbqjb - hkrmzrtnqu)
Phase 1
24
(75 mg twice daily)
dokoybcvbn(xesfgjkewd) = eoheiviegx japuozqhrq (duziwfyelq )
Positive
01 Sep 2018
(75 mg once daily)
dokoybcvbn(xesfgjkewd) = lqomoecshx japuozqhrq (duziwfyelq )
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Regulation

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