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L-ornithine L-aspartate
L-ornithine L-aspartate enhances ammonia detoxification by promoting urea cycle function and glutamine synthesis in hepatic encephalopathy.
L-ornithine L-aspartate enhances ammonia detoxification by promoting urea cycle function and glutamine synthesis in hepatic encephalopathy. Used for Hepatic encephalopathy (acute and chronic), Portal-systemic encephalopathy.
At a glance
| Generic name | L-ornithine L-aspartate |
|---|---|
| Also known as | Hepa-Merz, Hepamerz |
| Sponsor | Medical University of Graz |
| Drug class | Ammonia-lowering agent |
| Target | Urea cycle enzymes (ornithine transcarbamylase, carbamoyl phosphate synthetase); glutamine synthetase |
| Modality | Small molecule |
| Therapeutic area | Hepatology / Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
The drug provides substrates (ornithine and aspartate) that stimulate the urea cycle and increase ammonia clearance through enhanced glutamine formation in muscle and liver. By reducing circulating ammonia levels, it alleviates the neurological symptoms associated with hepatic encephalopathy, particularly in patients with chronic liver disease or portal hypertension.
Approved indications
- Hepatic encephalopathy (acute and chronic)
- Portal-systemic encephalopathy
Common side effects
- Gastrointestinal disturbances (nausea, diarrhea)
- Hyperammonemia (paradoxical, rare)
- Headache
Key clinical trials
- The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules (PHASE4)
- An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy (PHASE2)
- Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) (NA)
- A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy. (PHASE4)
- Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome (PHASE4)
- 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 (PHASE4)
- Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy (PHASE4)
- Efficacy of L-ornithine L-aspartate and Therapeutic Plasma Exchange Versus Plasma Exchange Alone in Lowering Ammonia and Improving Outcomes in Pediatric Acute Liver Failure. (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- L-ornithine L-aspartate CI brief — competitive landscape report
- L-ornithine L-aspartate updates RSS · CI watch RSS
- Medical University of Graz portfolio CI