HuaTangNing (dorzagliatin) / Hua Medicine - LARVOL DELTA

Resetting the glucose sensor: dorzagliatin and the evolution of glucokinase activation in diabetes therapy. (PubMed, BMJ Open Diabetes Res Care) - "Should future CVOTs demonstrate safety and efficacy, GKAs like dorzagliatin could potentially be integrated into treatment guidelines, possibly as a "sensor-calibrator" for a subset of patients identified through metabolic and genetic phenotyping. However, it must be emphasized that no CVOT data are currently available for dorzagliatin."

Journal • Review • Cardiovascular • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Real-world safety and efficacy of dorzagliatin in type 2 diabetes: interim analysis from a multicentre Phase IV study (EASD 2026) - P4 | "Across a large and clinically heterogeneous T2DM population receiving diverse antidiabetic regimens, dorzagliatin exhibited a consistently favorable benefit-risk profile alongside meaningful glycemic benefits, supporting its utility in real-world clinical practice."

Clinical • P4 data • Real-world • Real-world evidence • Diabetes • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Study on Improving Blood Glucose Homeostasis With Dorzagliatin Tablets in the Treatment of Type 2 Diabetes Mellitus Patients With Moderate to Severe Chronic Renal Insufficiency (clinicaltrials.gov) - P=N/A | N=206 | Not yet recruiting | Sponsor: Sun Yat-sen University

New trial • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Exploring the Clinical Pharmacokinetics of Sitagliptin in Healthy and Diseased Populations: A Systematic Critical Review. (PubMed, Ther Drug Monit) - "This review summarizes the available PK data on sitagliptin from published studies in healthy and diseased subjects. These data may be useful for developing physiologically based PK models and may provide additional information to support clinicians in optimizing sitagliptin dosing in patient populations."

Journal • PK/PD data • Chronic Kidney Disease • Diabetes • Hepatology • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes (clinicaltrials.gov) - P4 | N=2024 | Completed | Sponsor: Hua Medicine Limited | Recruiting ➔ Completed | Trial primary completion date: Apr 2026 ➔ Dec 2025

Trial completion • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Treatment Options for Patients with Maturity-Onset Diabetes of the Young (MODY): A Systematic Review of Literature: 2026 Update. (PubMed, Diabetes Ther) - "A major limitation of the available evidence is the predominance of small, heterogeneous observational studies, which limits the strength and generalizability of therapeutic recommendations. Recent literature largely confirms existing genotype-guided treatment recommendations while suggesting expanded therapeutic options for selected MODY subtypes. Precision medicine based on molecular diagnosis remains essential for optimal management."

Journal • Review • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • HNF1A • KCNJ11

Synergistic Effects of Dorzagliatin and Chiglitazar on Metabolic in DIO mice with MASLD (ADA 2026) - "Combined dorzagliatin and chiglitazar enhanced glycemic control beyond either agent alone, improving both basal and glucose-stimulated disposal, while partially mitigating chiglitazar-induced body weight gain. Although hepatic histology was unchanged, these findings underscore the potential of this combination to address metabolic dysregulation in MASLD. Further preclinical and clinical studies are warranted to explore the metabolic and hepatic benefits of this dual-mechanism approach."

Late-breaking abstract • Preclinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Dorzagliatin Improves Glycemic Control in Type 2 Diabetes Patients with Different Time in Range (TIR): A Subgroup Analysis of Six-Month Interim Results from a Prospective Real-World Study (ADA 2026) - "Dorzagliatin demonstrates promising efficacy in glycemic control in real-world T2D patients characterized by a long disease duration and a high prevalence of combination therapy with multiple antidiabetic agents including insulin, even in cases with severely compromised baseline TIR."

Clinical • Late-breaking abstract • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Synergistic Effects of Dorzagliatin and Orforglipron on Glycemic Control and Adiposity in DIO Mice (ADA 2026) - "Combined dorzagliatin and orforglipron enhanced glycemic control beyond either agent alone, improving both basal and glucose-stimulated disposal while maintaining potent weight reduction. This dual-mechanism oral strategy may allow for optimized GLP-1RA dosing, potentially reducing gastrointestinal side effects and improving treatment adherence in people with obesity-associated metabolic disorders. These findings warrant further investigation in clinical studies to confirm the benefit of this novel combination."

Preclinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Synergistic Metabolic and Hepatic Benefits of Dorzagliatin and Resmetirom in MASLD Mice (ADA 2026) - "In DIO mice, dorzagliatin and resmetirom combination therapy provided additional metabolic benefits compared with monotherapy, including synergistic improvements in glycemic control, greater triglyceride reduction, and significant lowering of serum uric acid. Dorzagliatin did not compromise, and in part enhanced, resmetirom's beneficial effects on hepatic ballooning and fibrosis. These findings highlight the potential value of dual targeting glucose and lipid metabolism for addressing the complex metabolic disturbances associated with MASH and support further investigation of combination strategies in metabolic disease."

Preclinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Structural Mechanisms and AI-Driven Prediction of Glucokinase Variants: Advancing Precision Medicine in MODY2 (ADA 2026) - "This study combines structural biochemistry and artificial intelligence (AI) to delineate the mechanistic effects of GK variants and forecast their responsiveness to the GK activator (GKA) dorzagliatin. We compiled a comprehensive database of ~1,000 GK variants from ClinVar, HGMD, and published literature... This work establishes clear structure-function relationships for GK mutations: active-site alterations impair substrates affinity, while allosteric/hinge perturbations disrupt allosteric regulation. Integrating mechanistic insights with AI prediction offers a powerful framework for MODY2 genetic diagnosis and patient stratification for targeted GKA therapy, accelerating precision medicine."

Metabolic Disorders

Safety and Efficacy of Dorzagliatin in Patients with Type 2 Diabetes under Real-World Clinical Practice: Preliminary Results from a Large-Scale Post-Marketing Study (ADA 2026) - "Dorzagliatin demonstrates excellent safety with robust glycemic control across diverse T2DM populations and treatment regimens, supporting its role in real-world clinical practice."

Clinical • P4 data • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Development of Preliminary Predictive Models for Dorzagliatin Treatment Response and Diabetes Remission in Type 2 Diabetes: A Focus on Personalized Medicine (ADA 2026) - "Subsequently, develop visual prediction applications based on these models. HbA1c-response-probability prediction model included the following factors: age, gender, BMI, diabetes duration, metformin use, baseline HbA1c, HOMA- β, and HOMA-IR. This study provided a practical tool for personalized medicine with dorzagliatin treatment in T2D. Predictive models and web-based visual prediction applications were developed to assist clinicians in identifying potential patients who can achieve glycemic control and diabetes remission."

Clinical • Predictive model • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Metabolic Targets APOC3 and GCK Influence Antipsychotic Efficacy in Schizophrenia (APA 2026) - "Conclusions The present study revealed that APOC3-proxied lipid-lowering enhanced antipsychotic efficacy, whereas GCK-related glucose reduction was associated with worse therapeutic outcomes. We firstly suggested that volanesorsen / olezarsen as potential adjunctive candidates, dorzagliatin warrants prudence in SCZ complicated by metabolic disturbance."

Clinical • CNS Disorders • Diabetes • Dyslipidemia • Metabolic Disorders • Psychiatry • Schizophrenia

RESENSE: Glucokinase Activator in Monogenic Diabetes (clinicaltrials.gov) - P2 | N=44 | Recruiting | Sponsor: Chinese University of Hong Kong | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders

A pharmacokinetic and pharmacodynamic drug-drug interaction study of dorzagliatin and empagliflozin in patients with type 2 diabetes and obesity: an open-label phase I trial. (PubMed, Nat Commun) - P1 | "The geomean ratio and their associated 90% confidence intervals for both maximum plasma concentration (empagliflozin: 98.43% (84.07%, 115.25%); dorzagliatin: 103.94% (90.45%, 119.44%)) and area under the concentration-time curve from 0 to 24 h (empagliflozin: 97.53% (94.35%, 100.82%); dorzagliatin: 99.65% (95.25%, 104.25%)) of empagliflozin and dorzagliatin fall entirely within the conventional bioequivalence range of 80.00% to 125.00%. No pharmacokinetic drug-drug interaction is observed, and the treatment exhibits a favorable safety profile with good overall tolerability."

Journal • P1 data • PK/PD data • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hematological Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Impact of glucokinase activators on the gut microbiota of high-fat diet-induced obese and type 2 diabetic mice. (PubMed, Front Microbiol) - "Substantial evidence indicates that long-term administration of oral glucose-lowering agents, such as metformin, can modulate the composition and function of the gut microbiota. Dorzagliatin and TTP399 are associated with alterations in gut microbiota composition at the genus level in HFD-fed mice, with a concomitant increase in the abundance of beneficial genera, and no significant association with changes in intestinal barrier integrity or inflammation. Further investigation is warranted to elucidate the association between long-term GKAs treatment and microbial communities, as well as the potential relationship between microbial changes and hypoglycemic effects."

Journal • Preclinical • Diabetes • Genetic Disorders • Inflammation • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Lipid-lowering and glucose-lowering drug targets differentially modulate antipsychotic treatment efficacy in schizophrenia. (PubMed, Cell Rep Med) - "Genetically proxied proteomics analysis provides further functional validation for the identified target-outcome associations. Our findings suggest volanesorsen/olezarsen as potential adjunctive candidates; dorzagliatin warrants prudence in schizophrenia with metabolic disturbance."

Journal • CNS Disorders • Diabetes • Dyslipidemia • Metabolic Disorders • Psychiatry • Schizophrenia

Contrasting Effects of Chronic Glucokinase Activation and Inhibition on Pancreatic Beta-Cell Function. (PubMed, FASEB J) - "Human islet microtissues or INS-1 cells were cultured at low or high glucose for 2 weeks (islets) or 48 h (INS-1 cells) in the presence or absence of either a glucokinase activator (MK-0941 or dorzagliatin) or a glucokinase inhibitor (mannoheptulose)...Chronic glucokinase activation in euglycaemia thus mimics the effects of chronic hyperglycaemia, whereas partial inhibition of glucokinase in hyperglycaemia restores normal beta-cell function. This explains why, in the long term, glucokinase activators are ineffective at controlling glycaemia in type 2 diabetes, and demonstrates that normalizing glucokinase activity can prevent and reverse chronic glucose toxicity."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

EFFECTS OF DORZAGLIATIN A NOVEL GLUCOKINASE ACTIVATOR , INSULIN GLARGINE AND METFORMIN ON NOCTURNAL GLUCOSE PRODUCTION IN TYPE 2 DIABETES (ATTD 2026) - "Both DG and IG show effects on early nocturnal EGP by reducing rates of GGL overnight with a smaller contribution of GNG. M used as monotherapy did not provide adequate lowering of nocturnal EGP. DG and IG combination may target GGL and GNG overnight thereby reducing nighttime glucose production."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hua Medicine…announced…that its global first-in-class glucokinase activator (GKA) dorzagliatin (Trade name: MYHOMSIS) 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. (The Manila Times)

Approval • Type 2 Diabetes Mellitus

Dorzagliatin shows potential in preventing cognitive impairment in diabetes: evidence from Mendelian randomization analysis and animal study. (PubMed, Front Endocrinol (Lausanne)) - "Maintaining glucose homeostasis directly regulates insulin pathway and glucose uptake, as well as enhances neurotransmission processes in the hippocampus. These findings not only highlight dorzagliatin as a promising therapeutic option for preventing diabetes-associated cognitive decline but also provide critical mechanistic insights into the role of GK modulated glucose homeostasis in preserving brain function, offering a potential translational strategy for clinical intervention."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • IR

Research of the efficacy and safety of dorzagliatin on latent autoimmune diabetes in adults(LADA) (ChiCTR) - P=N/A | N=60 | Recruiting | Sponsor: The First Affiliated Hospital of Bengbu Medical University; The First Affiliated Hospital of Bengbu Medical University | -> Recruiting

Enrollment open • Diabetes • Immunology • Metabolic Disorders

Efficacy and safety of Dorzagliatin in real-world populations with type 2 diabetes: a China multicenter retrospective study (EASTERN Study） (ChiCTR) - P4 | N=800 | Not yet recruiting | Sponsor: Shanghai General Hospital; Shanghai General Hospital

New P4 trial • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

TAT-PBX1 Reverses Hyperglycemia Through β-Cell Regeneration and Functional Restoration in an STZ-Induced Diabetic Model. (PubMed, Pharmaceuticals (Basel)) - "Its protective effects were assessed in STZ-treated MIN6 β cells and in a mouse model of STZ-induced diabetes, with the glucokinase (GK) activator dorzagliatin included as a positive control... TAT-PBX1 restores β-cell function through coordinated protection of cellular metabolism and insulin signaling, leading to improved β-cell survival, glucose responsiveness, and regenerative capacity. These findings support TAT-PBX1 as a promising molecular strategy for β-cell-protective and β-cell-restorative diabetes therapy."

Journal • Diabetes • Metabolic Disorders • PARP1 • PBX1 • PDX1