Dorzagliatin has been evaluated in numerous clinical trials spanning Phase 1 to Phase 4 development to investigate Type 2 Diabetes Mellitus, diabetic nephropathy, monogenic diabetes, cystic fibrosis-related diabetes, and pharmacokinetics in renal or hepatic impairment. Sponsored by Hua Medicine Limited alongside academic institutions such as Sun Yat-sen University and the Chinese University of Hong Kong, these studies—encompassing completed, recruiting, active, and not yet recruiting statuses—comprehensively characterize the compound's safety and efficacy profile.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07786571 | NOT_YET_RECRUITING | Type 2 Diabetes Mellitus (T2DM); Chronic Renal Insufficiency; Chronic Kidney Disease (Stages 3b-5); Glucose Homeostasis |
Sun Yat-sen University |
2026-12-01 | |
| NCT06995651 | RECRUITING | Pancreatic Insufficiency; Cystic Fibrosis-related Diabetes |
Michael R. Rickels, MD, MS |
2025-10-21 | PHASE1 |
| NCT06976658 | RECRUITING | Diabetes Mellitus; Monogenic Diabetes |
Chinese University of Hong Kong |
2025-04-30 | PHASE2 |
| NCT06263348 | COMPLETED | Type2diabetes |
Hua Medicine Limited |
2024-01-17 | PHASE4 |
| NCT06671340 | NOT_YET_RECRUITING | Diabetes Mellitus; Prediabetes / Type 2 Diabetes |
Elaine Chow |
2025-04-02 | |
| NCT05098470 | ACTIVE_NOT_RECRUITING | Type 2 Diabetes |
University of Alabama at Birmingham |
2022-03-07 | PHASE3 |
| NCT06222476 | UNKNOWN | Diabetic Nephropathy Type 2 |
Yan Bi |
2024-02-20 | |
| NCT05468229 | UNKNOWN | Glucose Intolerance |
Chinese University of Hong Kong |
2022-08 | PHASE1; PHASE2 |
| NCT04531631 | COMPLETED | Diabetes Mellitus, Type 2 |
Chinese University of Hong Kong |
2020-09-30 | PHASE2 |
| NCT03790787 | COMPLETED | Patients |
Hua Medicine Limited |
2019-04-18 | PHASE1 |
| NCT03790839 | COMPLETED | Patients |
Hua Medicine Limited |
2019-01-31 | PHASE1 |
| NCT04324424 | Completed | Type 2 Diabetes Mellitus |
Hua Medicine Limited |
2019-04-23 | Phase 1 |
| NCT04426708 | Completed | Type 2 Diabetes Mellitus |
Hua Medicine Limited |
2019-02-18 | Phase 1 |
| NCT03790839 | Completed | Patients |
Hua Medicine Limited |
2019-01-31 | Phase 1 |
| NCT04080609 | COMPLETED | Drug Interaction |
Hua Medicine Limited |
2018-03-27 | PHASE1 |
| NCT04080596 | COMPLETED | Drug Interaction |
Hua Medicine Limited |
2017-10-13 | PHASE1 |
| NCT03158506 | Completed | Healthy Subject |
Hua Medicine Limited |
2017-03-29 | Phase 1 |
| NCT02597400 | Completed | Type 2 Diabetes Mellitus |
Hua Medicine Limited |
2015-10 | Phase 1 |
| NCT02077452 | Completed | Type 2 Diabetes Mellitus |
Hua Medicine Limited |
2014-03 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-08-26)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).