Ruiqin (henagliflozin) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Comparative Analysis of Efficacy, Medication Adherence and Safety Between Henagliflozin Proline, Retagliptin Phosphate and Metformin Hydrochloride Sustained-release Tablets and Triple Antidiabetic Regimen in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control after Dual Oral Therapy (ChiCTR) - P=N/A | N=300 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Zhejiang University School of Medicine; The Second Affiliated Hospital of Zhejiang University School of Medicine

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

Randomized double-blind controlled clinical study of SGLT-2i combined with probiotic preparations in elderly patients with HFpEF (ChiCTR) - P=N/A | N=162 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Air Force Military Medical University; The First Affiliated Hospital of Air Force Military Medical University

New trial • Cardiovascular • Heart Failure • ICAM1

Effects and Safety of Henagliflozin on Cardiac Structure in Dialysis Patients with Heart Failure with Preserved Ejection Fraction. (PubMed, Clin J Am Soc Nephrol) - "Henagliflozin was associated with a greater reduction in LVMI at week 24 compared with placebo and was tolerable in dialysis patients with HFpEF. Larger studies are needed to confirm the LVMI-lowering effect of henagliflozin."

Clinical • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Efficacy and safety of henagliflozin in IgA nephropathy: A real-world observational study from China. (PubMed, Clin Nephrol) - "Henagliflozin demonstrated significant albuminuria- and UA-lowering effects over 12 weeks in Chinese IgAN patients. With renal-metabolic benefits and favorable safety, henagliflozin is emerging as an encouraging therapeutic option for IgAN."

Journal • Observational data • Real-world evidence • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Nephrology • Renal Disease

Case Report: Early-onset euglycemic diabetic ketoacidosis following henagliflozin initiation in a treatment-naive patient. (PubMed, Front Endocrinol (Lausanne)) - "A 40-year-old woman with newly diagnosed type 2 diabetes (HbA1c 12.9%) was initiated on metformin, henagliflozin (SGLT2 inhibitor), and chiglitazar. In treatment-naive patients initiating SGLT2 inhibitor-based combination therapy, common metformin-associated gastrointestinal symptoms (10-30% of initiants) can precipitate severe euDKA within days through reduced oral intake and dehydration. Although these are well-recognized precipitants, this case underscores the vulnerability of treatment-naive patients to routine adverse effects during the critical initial phase, highlighting the need for stepwise drug initiation, explicit sick-day education, and scheduled early follow-up."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Henagliflozin attenuates adverse ventricular remodeling and improves cardiometabolic parameters in patients with type 2 diabetes and hypertension: real-world evidence from a propensity score-matched analysis. (PubMed, Cardiovasc Diabetol) - "In patients with T2DM and hypertension, the addition of henagliflozin to standard therapy over 6 months was associated with significant attenuation of adverse ventricular remodeling-as evidenced by reductions in LVMI, left atrial diameter, and diastolic filling indices-alongside clinically meaningful improvements in glycemic control, blood pressure, and body weight."

HEOR • Journal • Real-world evidence • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

Henagliflozin promotes mitophagy in renal tubular cells by activating AMPK/ULK1 to alleviate the progression of diabetic kidney disease. (PubMed, Histol Histopathol) - "Hen exerts renoprotection effects by regulating AMPK/ULK1-dependent mitophagy, offering a novel therapeutic strategy for the clinical application of Hen."

Journal • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • ULK1

Randomized Double-blind Controlled Clinical Study of SGLT-2i Combined With Probiotic Preparations in Elderly Patients With HFpEF (clinicaltrials.gov) - P1/2 | N=162 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Air Force Medicial University

New P1/2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • ICAM1

Pharmacokinetic interactions between three SGLT2 inhibitors and telmisartan: A focus on empagliflozin, ertugliflozin, and henagliflozin. (PubMed, PLoS One) - "Our findings highlight the importance of these drug interactions, which could inform dose adjustments to enhance safety in patients with T2DM and hypertension."

Journal • PK/PD data • Breast Cancer • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Oncology • Solid Tumor • Type 2 Diabetes Mellitus

Efficacy and Safety of Simplified SGLT2i-Based Stepwise Intensive Therapy in Inducing of Diabetes Remission in Newly Diagnosed Type 2 Diabetes with Severe Hyperglycemia: A Pilot Study (ADA 2026) - "Group A received inpatient SIIT to achieved nearnormoglycemia (FBG<6.0 mmol/L, 2hBG<7.8 mmol/L) for 3 days, followed by 8-week outpatient therapy with insulin glargine, Henagliflozin (10 mg/d), metformin (up-titrated to 1.5 g/d or maximum tolerance), and remote lifestyle management. This pilot study demonstrates that SGLT-2i-based stepwise intensive therapy achieves comparable 24-week remission rates to conventional SIIT ,with advantages in improving insulin sensitivity and weight reduction."

Clinical • Diabetes • Metabolic Disorders • 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)...Conclusions 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

Effect of a Single Dose of Henagliflozin on Fractional Excretion of Sodium in Patients with Cirrhosis and Refractory Hepatic Hydrothorax and/or Ascites: A Multicenter, Open-Label, Randomized Controlled Trial (ChiCTR) - P=N/A | N=30 | Sponsor: The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

New trial • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

Endothelin Receptor Antagonist Ambrisentan, SGLT2 Inhibitor Henagliflozin, and Their Combination in IgA Nephropathy: A Randomized Crossover Trial. (PubMed, J Am Soc Nephrol) - "Combining an ERA with an SGLT2 inhibitor further reduced proteinuria versus SGLT2 inhibitor alone, with less fluid retention than ERA alone."

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

Efficacy and hypoglycemia-related safety of henagliflozin or dapagliflozin as add-on to CSII in hospitalized patients with T2DM: A retrospective matched study using continuous glucose monitoring. (PubMed, J Diabetes Complications) - "In hospitalized T2DM patients on CSII, adding henagliflozin or dapagliflozin-despite not improving key efficacy metrics such as time in range (TIR) or reducing hypoglycemia incidence-significantly enhanced glycemic stability and lowered daily insulin requirements, without increasing total hospitalization costs despite higher medication expenses. These findings support henagliflozin as an effective option for optimizing glycemic stability in this setting."

Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

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

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