Drugs / Dorzagliatin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | type 2 diabetes mellitus | 2021-04-23 | “In March 2021, Hua Medicine submitted the new drug application (NDA) of dorzagliatin to the China National Medical Products Administration (NMPA) for T2D treatment” huamedicine.com ↗ “In March, the New Drug Application (NDA) of dorzagliatin was submitted to China National Medical Products Administration (NMPA) and accepted in April.” huamedicine.com ↗ “The Company submitted the NDA for dorzagliatin, the first-in-class oral drug for the T2DM in March 2021 and was accepted by NMPA on April 23, 2021.” huamedicine.com ↗ “NDA for dorzagliatin for the treatment of Type 2 Diabetes (T2D) was accepted by the China National Medical Products Administration (NMPA).” huamedicine.com ↗ |
| Filed | Other | MYHOMSIS | type 2 diabetes mellitus | — | “A registration application has been submitted in Hong Kong for Dorzagliatin 75mg brand name: (MYHOMSIS ® , 華領片 TM )” huamedicine.com ↗ “The Company filed its application for registration of dorzagliatin in Hong Kong at the end of July” huamedicine.com ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT06995651 | Oct 2025 → Jul 2027 expected | cystic fibrosis-related diabetes | Michael R. Rickels, MD, MS | Recruiting | No outcome recorded |
| Phase 1 | NCT04324424 | Apr → Sep 2019 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT03790787 | Apr 2019 → Mar 2020 | — | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT04426708 | Feb 2019 → Jul 2020 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT03790839 | Jan → Aug 2019 | — | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT04080609 | Mar → Apr 2018 | — | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT04080596 | Oct → Dec 2017 | — | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT03158506 | Mar → Apr 2017 | — | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT02597400 | Oct 2015 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT02386982 | Mar → May 2015 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT02077452 | Mar → Sep 2014 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 1 | NCT01952535 | Sep → Dec 2013 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT04531631 | Sep 2020 → Feb 2022 | type 2 diabetes mellitus | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT02561338 | Sep 2015 → Sep 2016 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | Met primary |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT05098470 | Mar 2022 → Jul 2025 overdue | type 2 diabetes mellitus | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03141073 | Oct 2017 → Feb 2021 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | Met primary |
| Phase 3 | NCT03173391 | Jul 2017 → Nov 2020 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06263348 | Jan 2024 → Dec 2025 | type 2 diabetes mellitus | Hua Medicine Limited | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06671340 | Apr → Dec 2025 overdue | type 2 diabetes mellitus | Elaine Chow | Not yet recruiting | No outcome recorded |
| — | NCT06222476 | Feb 2024 → May 2025 | diabetic kidney disease | Yan Bi | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT05468229 Comparator | Aug 2022 → Apr 2023 | glucose intolerance | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT06976658 Comparator | Apr 2025 → Dec 2026 expected | monogenic diabetes | Chinese University of Hong Kong | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 38
| Date | Issuer | Release |
|---|---|---|
| 2026-06-30 | Hua Medicine Limited | Regulatory [NEWS] Hua Medicine's Dorzagliatin Approved for Type 2 Diabetes Treatment in Macao SAR, China huamedicine.com ↗ |
| 2026-06-09 | Hua Medicine Limited | Results [News] Hua Medicine Advances Glucose Homeostasis Platform at ADA 2026, Showcasing Dorzagliatin's Potential Across Metabolic Disease huamedicine.com ↗
Hua Medicine ("the Company", stock code: 2552.HK) presented a series of breakthrough research findings on dorzagliatin (Trade name: 华堂宁®, HuaTangNing, Trade name in Hong Kong: MYHOMSIS®, 華領片®), the world’s first-in-class glucokinase activator (GKA), at the 86th Scientific Sessions of the American Diabetes Association (ADA). |
| 2026-03-03 | Hua Medicine Limited | Regulatory [News] Hua Medicine Announces the Approval of Dorzagliatin for Marketing in Hong Kong SAR, China huamedicine.com ↗
dorzagliatin (Trade name: MYHOMSIS®, 華領片®) has been approved for marketing by the Pharmaceutical Service of the Department of Health of the Hong Kong Special Administrative Region of China for the treatment of Type 2 diabetes in adults. |
| 2025-09-29 | Hua Medicine Limited | Regulatory [News] Hua Medicine Announces that the Pharmaceutical Service of Hong Kong Department of Health of China has Officially Accepted the Application for Marketing Authorization of the New Drug Dorzagliatin huamedicine.com ↗
Hua Medicine ("the Company", HKEX: 2552) announced that the Department of Health of the Hong Kong Special Administrative Region of China accepted a New Drug Application (NDA) for dorzagliatin, the world’s first glucokinase activator (GKA) approved for the treatment of Type 2 diabetes (T2D). |
| 2025-06-23 | Hua Medicine Limited | Results [News] Hua Medicine Announces at 2025 ADA Scientific Sessions that Dorzagliatin Combined with DPP-4 Inhibitor Shows Promise in Reducing Blood Lipids While Restoring Glucose Homeostasis huamedicine.com ↗
A preclinical animal study showed that the combination of dorzagliatin and sitagliptin, a DPP-4 inhibitor, improves blood glucose levels, promotes insulin secretion, and enhances GLP-1 secretion. |
| 2025-06-18 | Hua Medicine Limited | Results [News] Hua Medicine Will Present Research Results and Be Invited to Broadcast Series of TV Reports at the 2025 American Diabetes Association (ADA) Scientific Sessions huamedicine.com ↗
Another investigator-initiated real-world study has clinically observed and demonstrated that dorzagliatin can significantly improve blood glucose levels in type 2 diabetes patients and restore their glycemic homeostasis and β-cell function. |
| 2024-11-30 | Hua Medicine Limited | Results Hua Medicine Announces Successful H.K. SENSITIZE Study Results at the CBIIC huamedicine.com ↗
The SENSITIZE 2 study results announced at CBIIC demonstrate that a single dose of dorzagliatin restores GK enzyme activity, significantly improving the second-phase insulin secretion and β-cell glucose sensitivity in individuals with impaired glucose tolerance (IGT) in hyperglycemic clamp study. |
| 2024-06-24 | Hua Medicine Limited | Results [News] Hua Medicine Announces Potential Effects of the Combination of Dorzagliatin and SGLT-2 Inhibitor at 2024 Annual Scientific Sessions huamedicine.com ↗
A basic research showed that dorzagliatin reduces glucose level by enhancing the secretion of insulin and GLP-1, and that the combination of dorzagliatin and the SGLT-2 inhibitor canagliflozin has superior glucose-reducing effects than monotherapy, providing a synergistic effect. |
| 2024-06-17 | Hua Medicine Limited | Results [News] Hua Medicine will present multiple research results at the 2024 American Diabetes Association (ADA) Annual Scientific Sessions huamedicine.com ↗
This study has verified that GKA dorzagliatin and SGLT2i canagliflozin reduce glucose levels through distinct mechanisms. |
| 2023-12-13 | Hua Medicine Limited | Regulatory [News] Hua Medicine Announces the Inclusion of Dorzagliatin in the National Reimbursement Drug List (NRDL) huamedicine.com ↗
Hua Medicine (the "Company", HKEx: 2552.HK) announced today that HuaTangNing (华堂宁 ® ) (dorzagliatin), its self-developed first-in-class glucokinase allosteric activator (GKA) for diabetes, has been successfully included in China's National Reimbursement Drug List (NRDL) by the National Healthcare Security Administration (NHSA). |
| 2023-11-23 | Hua Medicine Limited | Results [News] Hua Medicine to Present Research Findings at CDS 2023 huamedicine.com ↗
This study discovered that by controlling brain glucose homeostasis, brain glucose uptake, and insulin resistance, continuous low-dose dorzagliatin treatment to GK rats from infancy can prevent GK rats from developing cognitive impairment phenotypes. |
| 2023-08-17 | Hua Medicine Limited | Results New publication shines spotlight on Hua Medicine's Dorzagliatin ability to achieve diabetes remission over 52-week period huamedicine.com ↗
Sending Type 2 diabetes into remission is now a possibility thanks to Hua Medicine's HuaTangNing 1 (华堂宁 ® ) (dorzagliatin), as reported in a new published paper based on data from a 52-week study. |
| 2023-06-26 | Hua Medicine Limited | Results [News] Hua Medicine Announces the Potential of Dorzagliatin in Cognitive Dysfunction at ADA 2023 huamedicine.com ↗
The study showed that compared to the vehicle control group, low-dose administration of dorzagliatin for 26 weeks significantly curbed the elevation of fasting blood glucose (FBG) in GK rats, while the memory function was effectively protected. |
| 2022-10-09 | Hua Medicine Limited | Regulatory [News] Hua Medicine's Innovative First-In-Class Glucokinase Activator (GKA) HuaTangNing(华堂宁®) Is Approved! New Type 2 Diabetes Treatment Paradigm to Begin in China huamedicine.com ↗
has been approved by the National Medical Products Administration (NMPA) of China on October 8th for two indications |
| 2022-06-07 | Hua Medicine Limited | Results Hua Medicine Announces Dorzagliatin can Restore Glucose Sensitivity and Early Phase Insulin Secretion in T2DM and GCK-MODY Patients at ADA 2022 huamedicine.com ↗
A post-hoc analysis that involved two Phase III clinical trials of dorzagliatin indicated that dorzagliatin can significantly improve early phase insulin secretion and glucose sensitivity of patients of Type 2 diabetes (T2D). |
| 2022-05-13 | Hua Medicine Limited | Results Hua Medicine Published Two Peer-Reviewed Papers in Nature Medicine, an International Top Medical Journal, on the Results of the Phase III Research of Dorzagliatin, a First-In-Class Investigational Diabetes Drug of Hua Medicine huamedicine.com ↗
May 13, 2022, Shanghai, China Hua Medicine (the "Company", stock code on the main board of the Hong Kong Stock Exchange: 2552.HK) today announces that, two peer-reviewed papers on the Phase III clinical trial results of dorzagliatin, a glucokinase activator (GKA) and first-in-class investigational drug of the Company for the treatment of diabetes, were published online simultaneously by Nature Medicine , an international top medical journal. |
| 2021-09-26 | Hua Medicine Limited | Results Researchers Present Key Research Results on Diabetes Remission of Dorzagliatin huamedicine.com ↗
The researchers comprehensively evaluated the subjects and set their individual HbA1c control goals, and the results of the research showed that the subjects had a 52-week glucose remission rate of 65.2% (95% CI, 53.4%, 77.0%) [1] during the research period. |
| 2021-06-21 | Hua Medicine Limited | Results Hua Medicine to present additional dorzagliatin trials data at ADA 2021 huamedicine.com ↗
Dorzagliatin as a Glucose Sensitizer Achieved Sustained Glycemic Control with Good Safety Profiles in Drug-Naïve T2D Patients in a 52-Week Phase 3 Monotherapy Trial (SEED) |
| 2021-05-31 | Hua Medicine Limited | Results Hua Medicine to present additional dorzagliatin data at ADA 2021 huamedicine.com ↗
Dorzagliatin is synergistic with sitagliptin or empagliflozin in improving blood glucose reduction and optimizing the islet β-cell function of T2D patients, improving patients’ insulin secretion. |
| 2021-04-23 | Hua Medicine Limited | Regulatory Hua Medicine Announces Acceptance of a New Drug Application for Dorzagliatin in China - First Glucokinase Activator (GKA) Globally huamedicine.com ↗
Hua Medicine (the "Company，"Stock Code: 2552.HK), today announced that the New Drug Application (NDA) for dorzagliatin for the treatment of Type 2 Diabetes (T2D) was accepted by the China National Medical Products Administration (NMPA). |
| 2020-12-18 | Hua Medicine Limited | Results Hua Medicine Successfully Completes Its Registration Phase III Trials. Announces 52-Week Results for DAWN (HMM0302), Dorzagliatin's Phase III Combination with Metformin Trial huamedicine.com ↗
Dorzagliatin is safe and well tolerated in both the 24-week and 52-week periods of the DAWN Trial in Chinese T2D patients who have failed glycemic control with maximum daily dose of metformin (1500mg/day) |
| 2020-11-26 | Hua Medicine Limited | Results Hua Medicine's Dorzagliatin Announces Additional Data to be Presented at CDS 2020 huamedicine.com ↗
Dorzagliatin also demonstrated the below characteristics: |
| 2020-10-14 | Hua Medicine Limited | Regulatory Hua Medicine Announces the Drug Manufacturing Permit Granted for Dorzagliatin huamedicine.com ↗
the Company has obtained the drug manufacturing permit for dorzagliatin, its investigational first-in-class drug, issued by the Shanghai Municipal Drug Administrative Bureau. |
| 2020-07-01 | Hua Medicine Limited | Results Hua Medicine Announces Positive 24-Week Topline Results of Phase III Metformin Combination Trial of Dorzagliatin huamedicine.com ↗
Hua Medicine today announced the positive 24-week top-line results from HMM0302, a Phase III registration trial in China of its global first-in-class glucokinase activator dorzagliatin add-on to metformin, a first line oral antidiabetic therapy in Type 2 diabetes. |
| 2020-06-18 | Hua Medicine Limited | Results Hua Medicine Successfully Completes SEED (HMM0301), Dorzagliatin’s Phase III Monotherapy Trial huamedicine.com ↗
June 18, 2020, Shanghai, China Hua Medicine (the"Company", Stock Code: 2552.HK), a leading innovative drug development company focused on developing novel therapies for the treatment of diabetes, today announced topline results from SEED (also known as HMM0301), the first Phase III trial with dorzagliatin. |
| 2020-06-15 | Hua Medicine Limited | Results Hua Medicine's Dorzagliatin Demonstrates Improvements in β-Cell Function in Data Presented at the American Diabetes Association's 80th Scientific Sessions huamedicine.com ↗
June 15, 2020, Shanghai, China Hua Medicine (the"Company", Stock Code: 2552. HK), a leading innovative drug development company focused on developing novel therapies for the treatment of diabetes, announced post-analysis results from dorzagliatin’s 24-week monotherapy trial SEED, (also known as HMM0301). |
| 2020-06-05 | Hua Medicine Limited | Results Hua Medicine To Present Comprehensive Data of its 24-week Monotherapy Trial Results at 2020 ADA Scientific Sessions huamedicine.com ↗
A Novel Dual‐acting Glucokinase Activator (GKA) Dorzagliatin (HMS5552) Achieved Primary Efficacy Endpoint with Good Safety Profiles in T2dm Patients After 24 Weeks of Treatment in a Phase III Monotherapy Trial |
| 2020-04-27 | Hua Medicine Limited | Results Hua Medicine Announces Positive Results of the Combination Study of Dorzagliatin with Empagliflozin (a SGLT-2 inhibitor) huamedicine.com ↗
Following OGTT, the combination treatment achieved significantly enhanced glucose lowering effect (AUEC: 279 h•mg/dL) over empagliflozin (AUEC: 452 h•mg/dL, P<0.01) or dorzagliatin (AUEC: 364 h•mg/dL, P<0.05) monotherapy. |
| 2020-01-06 | Hua Medicine Limited | Results Hua Medicine Announces Positive Results of HMM0110 and HMM0111 huamedicine.com ↗
In subjects with end stage renal disease (ESRD, eGFR < 15 mL/min/1.73 m2) and are not on dialysis, as compared to healthy subjects whose renal function is normal, the ratio of dorzagliatin Cmax and AUCinf were 0.81 (90% CI: 0.64, 1.01) and 1.10 (90% CI:0.94, 1.28) respectively, indicating no significant impact of renal impairment on subjects exposed to dorzagliatin. |
| 2019-11-25 | Hua Medicine Limited | Results Hua Medicine Presents First Public Academic Report on Phase III Registration Trial Results of its Global First-in-Class Drug huamedicine.com ↗
数据显示：Dorzagliatin治疗24周后糖化血红蛋白相对基线降低1.07%，药效显著优于安慰剂(p<0.0001)；同时，Dorzagliatin 安全耐受性好，无药物相关的严重不良事件发生，低血糖发生率低于1%，且未出现以往糖尿病新药临床试验中常见的严重低血糖事件，稳态血糖达标率为45%。 |
| 2019-11-25 | Hua Medicine Limited | Results Good News: Hua Medicine’s Global First-in-Class Drug Was Presented at 2019 Scientific Meeting of CDS huamedicine.com ↗
dorzagliatin achieved primary efficacy endpoint in the Phase III clinical study of monotherapy (HMM0301) in drug naïve type 2 diabetes patients, with good safety, tolerance and significant therapeutic effect. |
| 2019-11-12 | Hua Medicine Limited | Results Hua Medicine’s Pivotal Phase III Monotherapy Trial of Dorzagliatin, a Dual-Acting Glucokinase Modulator, Achieves Primary Efficacy Endpoint in Patients with Type 2 Diabetes huamedicine.com ↗
Hua Medicine today announced 24-week top-line results from HMM0301 [NCT03173391], the first Phase III trial of a novel first-in-class dualacting glucokinase (GK) activator, dorzagliatin (HMS5552), which was designed to restore glucose homeostasis in adults with type 2 diabetes. |
| 2019-06-20 | Hua Medicine Limited | Results Hua Medicine – Recap of ADA 79th Scientific Sessions huamedicine.com ↗
This suggests that T2D patients can be differentiated using a hyperdimensional clustering framework, and supports the potential of using dorzagliatin in combination with other anti-diabetic agents for personalized T2D care in the future. |
| 2016-10-17 | Hua Medicine Limited | Results Hua Medicine Announces First-Ever Successful Phase 2 Monotherapy Trial for New Class of Diabetes Drug huamedicine.com ↗
Hua Medicine, a leading clinical stage biotech company in Shanghai, announced today positive results in the first-ever successful Phase 2 monotherapy trial of a novel drug class called glucokinase activators (GKA). |
| 2015-08-11 | Hua Medicine Limited | Results Hua Medicine’s GKA Diabetes Drug Demonstrates High Efficacy in 4-week Phase 1c Trial huamedicine.com ↗
This latest Phase 1c trial demonstrated an impressive 1% HbA1c average reduction in patients compared to their baseline blood levels after only 4 weeks of treatment. |
| 2015-03-10 | Hua Medicine Limited | Regulatory Hua Medicine Files IND in US for Its Novel GKA-Based Diabetes Drug huamedicine.com ↗ |
| 2015-02-09 | Hua Medicine Limited | Results Hua Medicine Announces Positive Phase 1b Results in Diabetes With 4th-Generation Glucokinase Activator, Shows Robust 24-Hour Glucose Control huamedicine.com ↗
HMS5552 (also known as sinogliatin) is a novel 4th-Generation glucokinase activator (GKA) for Type 2 Diabetes which demonstrated excellent 24-hour glucose control of both fasting plasma glucose (FPG) and post-meal glucose (PMG) levels in diabetic patients. |
| 2014-03-19 | Hua Medicine Limited | Results Hua Medicine's Novel Glucokinase Activator Reports Positive Phase 1a Data Demonstrating Robust Glucose Regulatory Hormone Modulation & Commences Phase 1b Trials in Diabetes Patients huamedicine.com ↗
In a dose-dependent manner, HMS5552 consistently increased post-meal GSIR multiple-fold above the post-meal insulin levels seen in the placebo group, with very low risk for hypoglycemia. |
All press releases naming this drug 47 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dorzagliatin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05468229 ↗ |
| Known as | Dorzagliatina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297508 ↗ |
| Known as | Dorzagliatine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297508 ↗ |
| Known as | HMS5552 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02386982 ↗ |
| Known as | RO-5305552 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297508 ↗ |
| Known as | Sinogliatin | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297508 ↗ |
| Action | Activate | “GK activator HMS5552” NCT02597400 ↗ |
| Modality | Small molecule | — CHEMBL4297508 ↗ |
| Route | Oral | “Each study subject will receive a single oral dose of HMS5552.” NCT01952535 ↗ |
| Target | GCK | “dual-acting orally bioavailable glucokinase activator targeting both the pancreas and liver glucokinase” PMID 35551292 ↗ May 2022 |