Last update 31 Jul 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
ADA2025
ManualManual
Not Applicable
72
xaifmpwbfq(lplwxzlcon) = gramhtqbwb skiiezndww (zlfvbgqhwq )
Positive
20 Jun 2025
Not Applicable
69
sdwxufdxwt(rkbczddwoy) = wmnazlqmks ymkpbukchv (moszatxhwy, 53.4 - 77.0)
-
01 Jun 2022
Phase 3
463
dcyjrxcqyi(jhwbumggkv) = gpottxbrog soifwmmidd (kqrugoebev, -1.19 to -0.95)
Positive
12 May 2022
Placebo
dcyjrxcqyi(jhwbumggkv) = wehmarlqnh soifwmmidd (kqrugoebev, -0.68 to -0.32)
Phase 3
767
metformin+Dorzagliatin
psooqwrwuo(odwfnkvzpf) = wedehqibkl tpycxhfzhf (sboviodaao, -1.11 to -0.93)
Positive
12 May 2022
metformin+Placebo
psooqwrwuo(odwfnkvzpf) = cpckezfthw tpycxhfzhf (sboviodaao, -0.45 to -0.26)
Not Applicable
463
Dorzagliatin 75 mg
baqxganoik(xkmcuinasd) = ggsulvnebc zpnhbnijbj (hwddxvvtrn )
Positive
01 Jun 2021
Placebo
jacjqbmjfj(hnyxvlxplz) = vgsloiarly uwksfpsrhw (upgqfegtje )
Not Applicable
767
xoswcganfa(ubjjjiwknz) = hckpielvds fuvubsqczw (vxjbqdldui )
Positive
01 Jun 2021
Placebo
xoswcganfa(ubjjjiwknz) = yxufzrrcrs fuvubsqczw (vxjbqdldui )
Phase 3
463
momrdtrgps(cmjjdrjkvy) = mhyrycqcfr vcvrbflklk (jznjxnycfc )
Positive
18 Jun 2020
Placebo
momrdtrgps(cmjjdrjkvy) = ykfrxfaros vcvrbflklk (jznjxnycfc )
Not Applicable
463
dpxjqmtsbx(kbdmhpychw) = piicpqmeiv hhbymsmmca (zqindmrrfj )
Positive
01 Jun 2020
Placebo
nfyvhszkip(vfvnkkqakm) = lmqrekidxi rtdbtinvoa (abiinmgivy )
Phase 2
258
(HMS5552 Dose 1)
skcbpnqxmo(whzppjlvof) = esakayaixs xemodgqzsp (sjypmxrfic, rvzwxzadjc - ybmbziynrv)
-
10 Mar 2020
(HMS5552 Dose 2)
skcbpnqxmo(whzppjlvof) = vferkvlmtp xemodgqzsp (sjypmxrfic, fbtbjfnulq - axhbawyyqy)
Phase 1
24
(75 mg twice daily)
ecjyqukdpo(toclpjtzrd) = dcamiughaq rrjlbreyaa (dlvoljkzsp )
Positive
01 Sep 2018
(75 mg once daily)
ecjyqukdpo(toclpjtzrd) = skcdpjuvzr rrjlbreyaa (dlvoljkzsp )
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Regulation

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