Dorzagliatin

Phase 3Small molecule

HHua Medicine Limited

Dorzagliatin is one of 46 small molecule programs targeting Type 2 Diabetes Mellitus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Type 2 Diabetes MellitusActive, not recruiting

Pancreatic InsufficiencyRecruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Pancreatic InsufficiencyPhase 1

Recruiting

Competition

Competitive Landscape

150 competitors in Type 2 Diabetes Mellitus

#DrugCompanyPhaseTrials

DWP16001

Daewoong Pharmaceutical Co. LTD.

Phase 3

5 2

Enavogliflozin

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 3

GZR18

GGan & Lee Pharmaceuticals.

Phase 3

5 4

HDM1002

HHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Phase 3

3 5

GZR4

GGan and Lee Pharmaceuticals, USA

Phase 3

5 6

Dorzagliatin

HHua Medicine Limited

Phase 3

12 7

Ganagliflozin

HHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Phase 3

1 8

TG103

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Phase 3

2 9

NOVOLIN R

Novo Nordisk

Preclinical

1 10

Adenocard

Astellas

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Monogenic Diabetes

NCT06976658

Q3 2027

Phase 1Recruiting

Pancreatic Insufficiency

NCT06995651

Clinical

Trials by Indication[1]

Type 2 Diabetes3 trials

Chronic Dorzagliatin on Insulin and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes

Not yet recruiting·EElaine Chow·N/A·NCT06671340·30 enrolled

Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.

Not yet recruiting·YYan Bi·N/A·NCT06222476·106 enrolled

A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus

Completed·HHua Medicine Limited·Approved·NCT06263348·2,024 enrolled

Monogenic Diabetes2 trials

Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes

Completed·—·Phase 2·NCT04531631·18 enrolled

Glucokinase Activator in Monogenic Diabetes

Not yet recruiting·—·Phase 2·NCT06976658·44 enrolled

Interaction1 trial

Drug Interaction Study Between Dorzagliatin and Sitagliptin

Completed·HHua Medicine Limited·Phase 1·NCT03790839·15 enrolled

Tics1 trial

DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin

Completed·HHua Medicine Limited·Phase 1·NCT04080596·18 enrolled

Empagliflozin1 trial

Drug Interaction Study Between Dorzagliatin and Empagliflozin

Completed·HHua Medicine Limited·Phase 1·NCT03790787·16 enrolled

2 more indications

Pancreatic Insufficiency1 trial

Pharmacokinetic and Pharmacodynamic Effects of Dorzagliatin in Pancreatic Insufficient-Cystic Fibrosis: A Randomized Double-blind, Cross-over Trial

Recruiting·UUniversity of Pennsylvania·Phase 1·NCT06995651·15 enrolled

Unspecified3 trials

Dorzagliatin and 1st Phase Insulin and Beta-cell Glucose Sensitivity in IGT and NGT

Unknown status·—·Phase 1/2·NCT05468229·20 enrolled

Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity

Active, not recruiting·UUniversity of Alabama at Birmingham·Phase 3·NCT05098470·100 enrolled

DDI Study Between Dorzagliatin and Rifampicin

Completed·HHua Medicine Limited·Phase 1·NCT04080609·15 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Dorzagliatin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dorzagliatin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dorzagliatin. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Hua Medicine Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: HHua Medicine Limited

Dorzagliatin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Type 2 Diabetes3 trials

Monogenic Diabetes2 trials

Interaction1 trial

Tics1 trial

Empagliflozin1 trial

Pancreatic Insufficiency1 trial

Unspecified3 trials

References

Drug Info

Quick Facts

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