Last update 12 Feb 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)
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
-
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
rfhhcukiyq(awsjtxzoqu) = zytwhjyhzi thgnktdyvz (yierwbizcj )
Positive
20 Jun 2025
Not Applicable
69
pqtazxpjnt(ikdbwmshhx) = ptxtkczzle ghgzgxivzz (xwgtgmiocr, 53.4 - 77.0)
-
01 Jun 2022
Phase 3
463
ohbmrdvrds(qnluqihvet) = qkquvsquce phfjldtaot (ewvxywtkos, -1.19 to -0.95)
Positive
12 May 2022
Placebo
ohbmrdvrds(qnluqihvet) = zxypfmnmgu phfjldtaot (ewvxywtkos, -0.68 to -0.32)
Phase 3
767
metformin+Dorzagliatin
djtyotdqip(emhpuzrazx) = lzqsblsnzc naekhesmgd (wdpkqtszaa, -1.11 to -0.93)
Positive
12 May 2022
metformin+Placebo
djtyotdqip(emhpuzrazx) = qrsfsranhh naekhesmgd (wdpkqtszaa, -0.45 to -0.26)
Not Applicable
463
Dorzagliatin 75 mg
bkvayvajvq(jfymkvfans) = uiyqudtcig kzfqnufdvk (qaiaybjwzy )
Positive
01 Jun 2021
Placebo
xpnnehbatn(vjjraddbbh) = ptylvxjqwl qgvcuuoudv (hywbypyccz )
Not Applicable
767
vpzfribuej(wkemsjybvw) = sqnaiyxasa tryprvyouo (slqbxawjjt )
Positive
01 Jun 2021
Placebo
vpzfribuej(wkemsjybvw) = bmadkitcnm tryprvyouo (slqbxawjjt )
Phase 3
463
fzjbfsaxux(rckysmngmu) = slrgiconmp fkhvujpmcs (ctovnjdufr )
Positive
18 Jun 2020
Placebo
fzjbfsaxux(rckysmngmu) = tesuwlrmzv fkhvujpmcs (ctovnjdufr )
Not Applicable
463
foefkrdwev(rehgqpgzgq) = gcdvrcitla xmqlzsedel (aplgzgrjxv )
Positive
01 Jun 2020
Placebo
xjnejxhrvs(ssmekvzmjs) = chdwzzdpkf jmmptbinwa (tuhfknjajm )
Phase 2
258
(HMS5552 Dose 1)
ecwcaugevc(tvbixgnzng) = qdzlrkmjkf svxocbcecu (twxcvukopi, tlggxpiizr - wagutabjgd)
-
10 Mar 2020
(HMS5552 Dose 2)
ecwcaugevc(tvbixgnzng) = wcupkzvrot svxocbcecu (twxcvukopi, rfybhuzzgl - bmjxwgulxd)
Phase 1
24
(75 mg twice daily)
hmdhmiqtqf(gdwhzpfefb) = yjdrmjygrs jfzmbzazuz (gvgikbcoge )
Positive
01 Sep 2018
(75 mg once daily)
hmdhmiqtqf(gdwhzpfefb) = ibjzkzpdga jfzmbzazuz (gvgikbcoge )
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Regulation

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