Ruiqin (henagliflozin) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Multicentre, Randomised, Controlled, Open-Label Study of Continuous Subcutaneous Insulin Infusion Plus Henagliflozin for Treating Type 2 Diabetes Mellitus Patients With Severe Hyperglycaemia. (PubMed, Diabetes Obes Metab) - P4 | "Henagliflozin + CSII achieved better glycaemic control, reduced insulin dosages and had a comparable safety profile versus CSII alone in severely hyperglycaemic T2DM patients."

Journal • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Nephrology • Type 2 Diabetes Mellitus

Do SGLT2 Inhibitors Influence Parkinson's Disease Risk? A Meta-analysis of Randomized Trials (AAN 2026) - "No eligible data were found for ertugliflozin, enavogliflozin, henagliflozin, ipragliflozin, luseogliflozin, or tofogliflozin...Subgroup analyses showed no significant effect for individual agents: empagliflozin 10 mg (OR 0.64, 95% CI 0.17–2.43), empagliflozin 25 mg (OR 0.33, 95% CI 0.01–8.15), dapagliflozin 10 mg (OR 0.33, 95% CI 0.09–1.23), sotagliflozin (OR 0.25, 95% CI 0.03–2.24), canagliflozin 100 mg (OR 3.00, 95% CI 0.31–28.81), and bexagliflozin (OR 1.50, 95% CI 0.06–36.99)... SGLT2 inhibitors do not significantly alter the risk of PD. These findings support their neurological safety, though longer follow-up and dedicated neurodegenerative outcome trials are warranted."

Retrospective data • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Movement Disorders • Nephrology • Parkinson's Disease • Renal Disease • Type 2 Diabetes Mellitus

Efficacy and Safety of Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets in Chinese Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

Clinical study on the effect of henagliflozin proline combined with metformin on serum markers of cognitive impairment related to type 2 diabetes (ChiCTR) - P2 | N=100 | Not yet recruiting | Sponsor: Affiliated Hospital of Xuzhou Medical University, Xuzhou City, Jiangsu Province; Affiliated Hospital of Xuzhou Medical University

New P2 trial • Alzheimer's Disease • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Randomized, controlled and open label clinical trial of metformin Henagliflozin compound preparation in the treatment of type 2 diabetes mellitus patients with metabolic fatty liver disease and its effect on liver and pancreas fat content (ChiCTR) - P4 | N=60 | Recruiting | Sponsor: The First People's Hospital of Foshan; The First People's Hospital of Foshan | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Hepatology • Metabolic Disorders • Type 2 Diabetes Mellitus

Henagliflozin for the Treatment of Patients with T2DM and CKD: A Real-World, Multicenter Case Registry Study (ChiCTR) - P4 | N=1000 | Completed | Sponsor: The 2nd Affiliated Hospital of Chongqing Medical University; The 2nd Affiliated Hospital of Chongqing Medical University

New P4 trial • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Henagliflozin enhances frontal neural activation and cognitive function versus gliclazide in type 2 diabetes patients with mild cognitive impairment: A 16-week randomized controlled trial. (PubMed, J Endocrinol Invest) - No abstract available

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

A multicenter, randomized, parallel-group clinical study on the effects of Henagliflozin Proline Tablets and Metformin Sustained-release tablets on body composition in geriatric patients with newly diagnosed type 2 diabetes mellitus (ChiCTR) - P=N/A | N=116 | Not yet recruiting | Sponsor: Huadong Hospital Affiliated to Fudan University; Huadong Hospital Affiliated to Fudan University

New trial • Diabetes • Geriatric Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus

Study on the effects of SGLT2 inhibitors on proximal tubular sodium reabsorption in patients with type 2 diabetes and chronic kidney disease under different sodium dietary conditions (ChiCTR) - P=N/A | N=57 | Not yet recruiting | Sponsor: The Fourth Medical Center of Chinese PLA General Hospital; The Fourth Medical Center of Chinese PLA General Hospital

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

HABIT-GEMs: Effects of Henagliflozin Proline and Metformin XR on Body Composition in Geriatric Patients With Newly Diagnosed T2DM (clinicaltrials.gov) - P4 | N=116 | Not yet recruiting | Sponsor: Bin Lu

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

Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR (clinicaltrials.gov) - P=N/A | N=150 | Not yet recruiting | Sponsor: Shanghai East Hospital

New trial • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Fibrosis • Hypertrophic Cardiomyopathy • Immunology • Non-obstructive Hypertrophic Cardiomyopathy

Health: Henagliflozin Reducing Infarct Size After Priamry PCI in Patients With ST Segment Elevation Myocardial Infarction (clinicaltrials.gov) - P4 | N=248 | Completed | Sponsor: Qian geng | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=181 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Fecal Microbiota Capsule Transplantation Combined with Henagliflozin in Patients with Type 2 Diabetic Kidney Disease (ChiCTR) - P=N/A | N=100 | Not yet recruiting | Sponsor: Affiliated Hospital of Southwest Medical University; Affiliated Hospital of Southwest Medical University

New trial • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Transplantation • Type 2 Diabetes Mellitus

Effects of Henagliflozin on Cardiac Structure in Patients with Heart Failure with Preserved Ejection Fraction Undergoing Dialysis: The HELD-HF Randomized Controlled Trial (KIDNEY WEEK 2025) - P=N/A | "The incidence of adverse events was similar between the two groups (35.7% in the henagliflozin group and 32.1% in the placebo group). Conclusion Henagliflozin significantly reduced LVMI compared with placebo in patients with HFpEF on dialysis and was safe over 24 weeks of treatment."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure

Randomized, controlled and open label clinical trial of metformin Henagliflozin compound preparation in the treatment of type 2 diabetes mellitus patients with metabolic fatty liver disease and its effect on liver and pancreas fat content (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: The First People's Hospital of Foshan; The First People's Hospital of Foshan

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

Efficacy of Henagliflozin in Patients with Type 2 Diabetes Mellitus and Overweight or Obesity (ChiCTR) - P4 | N=5000 | Not yet recruiting | Sponsor: Beijing Chaoyang Hospital, Capital Medical University; Beijing Chaoyang Hospital, Capital Medical University

New P4 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Randomized Crossover Trial on the Effect of Henagliflozin on Heart Stress in Patients with Stage B Heart Failure (ChiCTR) - P3 | N=38 | Not yet recruiting | Sponsor: Guangdong Provincial Yingde People's Hospital; Guangdong Provincial Yingde People's Hospital

New P3 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

Henagliflozin Increases Serum and Salivary Levels of High-Molecular-Weight Adiponectin in Patients with Type 2 Diabetes in the Community. (PubMed, Int J Gen Med) - "In order to reveal the influence factors of adiponectin in serum and saliva, linear stepwise regression analysis showed that waist circumference was an independent risk factor for adiponectin in serum (95% CI: -0.087, -0.015; P < 0.05), and gender was an independent risk factor for adiponectin in saliva (95% CI: -4.663, -0.529; P < 0.05). In our study, serum and salivary HMW adiponectin levels were decreased in patients with T2DM, and Sodium-glucose co-transporter-2 (SGLT2) inhibitors could improve serum and salivary HMW adiponectin levels after treatment, which is expected to be a major target for diabetes treatment."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients With New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study (clinicaltrials.gov) - P4 | N=268 | Recruiting | Sponsor: Zhejiang Provincial People's Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

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

Efficacy and safety of a novel oral small molecule GLP-1RA (HRS-7535) in Chinese patients with type 2 diabetes inadequately controlled by metformin and SGLT2 inhibitor (EASD 2025) - P2 | "During the lead in period, HRS-7535 placebo tablet and henagliflozin metformin extended-release tablets were administrated to pts. HRS-7535 achieved significant HbA1c reduction in Chinese pts with T2DM inadequately controlled on metformin and an SGLT2 inhibitor, and exhibited a safety profile consistent with other GLP-1RAs. These data support further clinical development of HRS-7535 for T2DM treatment."

Clinical • Late-breaking abstract • Diabetes • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Effect of henagliflozin on aging biomarkers in patients with type 2 diabetes: A multicenter, randomized, double-blind, placebo-controlled study. (PubMed, Cell Rep Med) - P4 | "These findings suggest that henagliflozin may exert anti-aging effects through multiple pathways. This study is registered at Chinese Clinical Trial Registry (ChiCTR2300068127)."

Biomarker • Clinical • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • GZMB • IGFBP3 • PRF1

Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial (clinicaltrials.gov) - P=N/A | N=24 | Completed | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting ➔ Completed | N=60 ➔ 24 | Trial completion date: Jun 2026 ➔ Jun 2025

Enrollment change • Trial completion • Trial completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

HOLIDYA: The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy (clinicaltrials.gov) - P4 | N=64 | Recruiting | Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2025 ➔ Jul 2025

Enrollment open • Trial initiation date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Physiologically-Based Pharmacokinetics and Empirical Pharmacodynamic Modeling for Pediatric Henagliflozin Dosing: Clinical Insights for Chinese Patients. (PubMed, Pediatr Diabetes) - "The verified PBPK and empirical PD models informed dosing recommendations in pediatric populations aged 1 month to 18 years, achieving henagliflozin exposures comparable to those in adult patients receiving a 5-10 mg dose. This study shows that PBPK and PD modeling effectively guide pediatric dosing of henagliflozin, reducing trial reliance and supporting real-world validation."

Journal • PK/PD data • Hepatology • Pediatrics