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Ornithine Aspartate
Ornithine Aspartate is a Small molecule drug developed by General Hospital of Shenyang Military Region. It is currently in Phase 1 development.
Ornithine Aspartate is a small molecule used in clinical trials to study its effects on various stages of Hepatic Encephalopathy, a condition associated with liver disease. It has been investigated as a potential treatment for Cirrhosis and its complications, including Hepatic Encephalopathy Stage 2, Stage 3, and Stage 4.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ornithine Aspartate |
|---|---|
| Sponsor | General Hospital of Shenyang Military Region |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
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:
- Ornithine Aspartate CI brief — competitive landscape report
- Ornithine Aspartate updates RSS · CI watch RSS
- General Hospital of Shenyang Military Region portfolio CI
Frequently asked questions about Ornithine Aspartate
What is Ornithine Aspartate?
Who makes Ornithine Aspartate?
What development phase is Ornithine Aspartate in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing