L-ornithine-L-aspartate / Generic mfg. - LARVOL DELTA

An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Comparison of efficacy of rifaximin, probiotics and L-ornithine L-aspartate in overt hepatic encephalopathy: a randomized, phase IV, lactulose controlled clinical trial. (PubMed, Trials) - P4 | "This randomized controlled trial protocol will compare the efficacy of four proposed groups of medications to fill the gap in current knowledge."

Clinical • Clinical protocol • Journal • P4 data • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis • Movement Disorders

Use of L-Ornithine L-Aspartate in Reducing Inpatient Hospital Length of Stay in Patients With Hepatic Encephalopathy: A Systematic Review and Meta-Analysis (ACG 2025) - "A total of 413 patients were included across the three studies, with 208 patients receiving intravenous LOLA therapy and 205 receiving placebo. A random-effects meta-analysis was performed to assess the difference in hospital LOS between the two groups. The pooled mean difference was −2.21 days (95% CI: −4.97, 0.55), suggesting a trend toward shorter stays with LOLA therapy, though this was not statistically significant (z=−1.57, p=0.116)."

Retrospective data • Review • CNS Disorders • Hepatic Encephalopathy • Hepatology • Liver Cirrhosis

EFFECTS OF LOLA ON THE GUT MICROBIOME AND PATIENT REPORTED QUALITY OF LIFE (UEGW 2025) - "We previously observed a positive influence of L-ornithine-L-aspartate (LOLA) on gut microbiome composition in cirrhosis (1)... In summary, LOLA was associated with an improvement in vitality, an important patient-reported outcome accompanied by alterations in gut microbial composition and prevented muscle loss in patients with hyperammonaemia. Furthermore, LOLA was associated with improvements in gut permeability and endotoxin handling. The slight increase in alanine observed in the metabolomics analysis may be a consequence of LOLA metabolism."

Clinical • HEOR • CNS Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatic Encephalopathy • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Liver Cirrhosis • Sarcopenia • FGF21 • IGF1 • LBP

An Observational Study to Evaluate the Effect of L-ornithine L-aspartate in Patients With Overt Hepatic Encephalopathy Receiving Lactulose and Rifaximin. (PubMed, Cureus) - "In this study, we observed that administering LOLA in conjunction with standard background therapy has significantly improved the grade of HE, as determined by the West Haven scoring system. Fasting serum ammonia levels, LFT parameters, and quality of life as per SF-36 also improved in the group that received LOLA. Thus, the addition of LOLA to the first-line standard therapy was found to be effective and might help in improving the clinical grade of HE."

Journal • Observational data • CNS Disorders • Hepatic Encephalopathy • Hepatology

An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Analysis and mining of L-ornithine L-aspartate adverse events based on FAERS database. (PubMed, Sci Rep) - "This study provides suggestions and directions for the rational and safe clinical application of LOLA. Prospective studies in the future are required to further investigate the occurrence of relevant adverse events."

Adverse events • Journal • Hepatology

ARGO-HEC: A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy. (clinicaltrials.gov) - P4 | N=252 | Completed | Sponsor: Qurratul Ain Jamil

New P4 trial • CNS Disorders • Hepatic Encephalopathy

An Open-Label Randomized Controlled Non-Inferiority Trial of Arginine Glutamate Injection for the Treatment of Mild Hepatic Encephalopathy. (PubMed, J Dig Dis) - "Both regimens effectively alleviated mild HE symptoms and reduced ammonia levels. Arginine glutamate showed non-inferiority to LOLA in terms of clinical improvement, ammonia reduction, and time to complete NCT-A, with no significant adverse events."

Head-to-Head • Journal • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

Sarcopenia in cirrhosis: a clinical practice review. (PubMed, Ann Palliat Med) - "Emerging therapies, such as including L-ornithine L-aspartate, leucine-enriched branch-chained amino acids, hold promise in modulating skeletal muscle. This review explores the definitions, clinical manifestations, and consequences of malnutrition, frailty, and sarcopenia in cirrhosis, emphasizing the importance of early assessment and intervention."

Journal • Review • CNS Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Sarcopenia • Transplantation

Brucella Melitensis Infection Leading to Septicemia in a Pediatric Patient: A Case Study and Literature Review. (PubMed, Infect Drug Resist) - "The patient was treated with ceftriaxone for antibacterial therapy, supplemented with doxycycline. Supportive therapy included bicyclol, glutathione, and L-ornithine L-aspartate for hepatoprotection...For patients with suspected infections, it is crucial to actively identify the causative pathogen and administer appropriate antimicrobial therapy based on laboratory results. Clinicians should emphasize etiological testing, using various staining techniques to improve diagnostic accuracy when identifying bacterial colonies on culture plates."

Journal • Hematological Disorders • Infectious Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Pediatrics • CRP

Efficacy and safety of L-ornithine L-aspartate combined with lactulose in treatment of hepatic encephalopathy: a systematic review and meta-analysis of randomized controlled trial. (PubMed, Front Med (Lausanne)) - "This study indicates that the combination of LOLA and lactulose in the treatment of hepatic encephalopathy has a higher total effective rate in clinical practice and can significantly reduce the levels of AST, ALT, TBIL, and NH3. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42024592957."

Journal • Retrospective data • Review • CNS Disorders • Hepatic Encephalopathy • Metabolic Disorders

L-ornithine-L-aspertate improves quality of life and ammonia levels but not microbiome dysbiosis in cirrhosis: results of a phase 4 study (EASL 2025) - "In a recent retrospective study, we showed that L-ornithine-L-aspartate (LOLA) was associated with less dysbiosis... LOLA improved vitality in patients with cirrhosis, a clinically relevant patient reported outcome parameter but did not alter gut microbiome composition and function and could not prevent cirrhosis associated muscle loss in the majority of the patients. LOLA may be a useful adjunct treatment to improve quality of life in cirrhosis and may prevent muscle loss in patients with elevated ammonia levels."

Dysbiosis • HEOR • P4 data • CNS Disorders • Fibrosis • Gastrointestinal Disorder • Hepatic Encephalopathy • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Liver Cirrhosis • Sarcopenia • FGF • IGF1

Hepatic Encephalopathy: Current Thoughts on Pathophysiology and Management. (PubMed, Curr Neurol Neurosci Rep) - "First protecting the liver and the brain from gut generated ammonia and other toxins by ensuring smooth bowel function and avoiding stagnation with the use of osmotic laxatives like lactulose or lactitol and also reducing the gut microbial load with use of anti-bacterials/bacteriophages like neomycin and rifaximin along with metronidazole...Currently L-ornithine L-aspartate (LOLA) is being used to reduce the ammonia load to the liver...Finally in resistant cases the use of liver transplant needs to be considered. Alternatively extracorporeal liver assist devices may be used like Molecular Adsorbent Recirculating System (MARS) or Single-Pass Albumin Dialysis (SPAD)."

Journal • Review • CNS Disorders • Hepatic Encephalopathy • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Liver Failure • Movement Disorders • Parkinson's Disease • Psychiatry • Transplantation • IL17A • IL6 • TNFA

Arginine glutamate injection for the treatment of mild hepatic encephalopathy: an openlabel, randomized, controlled, non-inferiority trial (APASL 2025) - P4 | "Both arginine glutamate injection and L-ornithine-L-aspartate injection effectively alleviated clinical symptoms and reduced blood ammonia levels in patients with cirrhosis and mild HE, with the clinical improvement rate of arginine glutamate being non-inferior to that of L-ornithine-L-aspartate. Compared to L-ornithine-L-aspartate, arginine glutamate also achieved non-inferiority in reducing blood ammonia and improving number connection test scores, with no appreciable adverse effects.(ChiCTR2300068160) Table and Figure:Figure 1.Figure1. Primary outcome of clinical improvement of hepatic encephalopathy in the intention-to-treat and per-protocol population."

Clinical • Head-to-Head • CNS Disorders • Fibrosis • Gastrointestinal Disorder • Hepatic Encephalopathy • Hepatology • Immunology

Hepatic encephalopathy: risk identification and prophylaxis approaches. (PubMed, Metab Brain Dis) - "Traditional treatments such as lactulose and rifaximin remain the cornerstone of HE management, effectively reducing ammonia levels and preventing recurrence. However, novel approaches like L-ornithine L-aspartate, albumin infusions, and antioxidants like resveratrol show promise in further improving outcomes by addressing underlying pathophysiological mechanisms, including systemic inflammation and gut dysbiosis...The future of HE management lies in personalized medicine, targeting specific inflammatory and metabolic pathways, with the potential integration of genetic manipulation. Continued research is essential to refine these strategies, ultimately aiming to improve the prognosis and quality of life for cirrhotic patients at risk of HE."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Immunology • Inflammation • Liver Cirrhosis

Unusual Presentation of Confusion: Hyperammonaemic Hepatic Encephalopathy Due to Intrahepatic Portosystemic Venous Shunt. (PubMed, Ir Med J) - "Management included the commencement of Lactulose, Rifaximin, and L-ornithine L-aspartate (LOLA). Intrahepatic portosystemic venous shunts should be considered in the differential diagnosis of patients presenting with confusion or other unexplained neurological symptoms, especially in the presence of liver dysfunction. Early diagnosis and appropriate management are crucial for favourable outcomes."

Journal • CNS Disorders • Fatigue • Hepatic Encephalopathy • Hepatology • Liver Failure

LOLAbiome: Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome (clinicaltrials.gov) - P4 | N=55 | Active, not recruiting | Sponsor: Medical University of Graz | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

Hepatic encephalopathy: experimental drugs in development and therapeutic potential. (PubMed, Expert Opin Investig Drugs) - "Standard therapies, including non-absorbable disaccharides and rifaximin, are widely used but show inconsistent efficacy. Alternatives such as polyethylene glycol and L-ornithine L-aspartate have been effective in certain cases...Additionally, the multifactorial nature of HE, together with a high spontaneous response rate, complicates efforts to isolate treatment effects. Despite current limitations, ongoing research and technological advances hold promise for more effective and individualized HE treatments in the future."

Clinical • Journal • Review • CNS Disorders • Hepatic Encephalopathy • Hepatology • Immune Modulation • Immunology • Inflammation • Transplantation

Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy (clinicaltrials.gov) - P4 | N=140 | Completed | Sponsor: Ain Shams University | Recruiting ➔ Completed

Trial completion • CNS Disorders • Hepatic Encephalopathy • Hepatology

ARGININE GLUTAMATE INJECTION FOR THE TREATMENT OF MILD HEPATIC ENCEPHALOPATHY: AN OPEN LABEL, RANDOMIZED, CONTROLLED, NON-INFERIORITY TRIAL (AASLD 2024) - "Both arginine glutamate injection and L-ornithine-L-aspartate injection effectively alleviated clinical symptoms and reduced blood ammonia levels in patients with cirrhosis and mild HE, with the clinical improvement rate of arginine glutamate being non-inferior to that of L-ornithine-L-aspartate. Compared to L-ornithine-L-aspartate, arginine glutamate also achieved non-inferiority in reducing blood ammonia and improving number connection test scores, with no appreciable adverse effects."

Clinical • Head-to-Head • CNS Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Immunology

Effects of L-Ornithine-L-Aspartate on Angiogenesis and Perfusion in Subacute Hind Limb Ischemia: Preliminary Study. (PubMed, Biomedicines) - "In conclusion, this study provides the first documented evidence of angiogenesis and perfusion recovery in the subacute phase of the HLI model following the administration of LOLA. With LOLA readily available on the commercial market, the implementation of LOLA treatment for PAD in humans can be expedited compared to other therapies still in the developmental stage."

Journal • Cardiovascular • Peripheral Arterial Disease • CD31 • PECAM1

Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy (clinicaltrials.gov) - P4 | N=140 | Recruiting | Sponsor: Ain Shams University | Trial completion date: Jul 2024 ➔ Oct 2024 | Trial primary completion date: Jul 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • CNS Disorders • Hepatic Encephalopathy • Hepatology

L-ORNITHINE L-ASPARTATE(LOLA) VERSUS STANDARD MEDICAL THERAPY (SMT) FOR IMPROVEMENT OF SARCOPENIA IN PATIENTS WITH CIRRHOSIS - A RANDOMIZED OPEN LABEL TRIAL (UEGW 2024) - "Full abstracts will be published on 21 September 2024"

Clinical • Fibrosis • Hepatology • Immunology • Sarcopenia

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) (clinicaltrials.gov) - P=N/A | N=174 | Not yet recruiting | Sponsor: General Hospital of Shenyang Military Region

New trial • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis