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keto-amino acids
Keto-amino acids provide nitrogen and carbon skeletons for protein synthesis while reducing the nitrogen load in patients with renal or hepatic impairment.
Keto-amino acids provide nitrogen and carbon skeletons for protein synthesis while reducing the nitrogen load in patients with renal or hepatic impairment. Used for Chronic kidney disease with hyperazotemia (to reduce protein catabolism and nitrogen accumulation), Hepatic encephalopathy (to reduce ammonia-generating amino acid load), Protein-energy malnutrition in renal failure.
At a glance
| Generic name | keto-amino acids |
|---|---|
| Also known as | Ketosteril®(Fresenius Kabi) |
| Sponsor | YUAN Wei-jie |
| Drug class | Amino acid supplement / Nutritional therapeutic |
| Modality | Small molecule |
| Therapeutic area | Nephrology, Hepatology, Metabolic disorders |
| Phase | FDA-approved |
Mechanism of action
Keto-amino acids (the α-ketoacid analogs of essential amino acids) are metabolized to their corresponding amino acids through transamination, allowing protein synthesis without accumulating excess nitrogen. This is particularly useful in chronic kidney disease and hepatic encephalopathy, where nitrogen retention is problematic. The α-ketoacid forms reduce the dietary protein burden while maintaining amino acid availability.
Approved indications
- Chronic kidney disease with hyperazotemia (to reduce protein catabolism and nitrogen accumulation)
- Hepatic encephalopathy (to reduce ammonia-generating amino acid load)
- Protein-energy malnutrition in renal failure
Common side effects
- Gastrointestinal upset
- Nausea
- Metallic taste
Key clinical trials
- Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions (PHASE2)
- Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma (PHASE2)
- Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA） (PHASE3)
- Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp (PHASE3)
- Prospective Evaluation of Efficacy of Tumescent Steroid Infiltration in Mandibular Third Molar Surgery: a Split Mouth Randomized Study (NA)
- Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401) (PHASE1)
- 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (EARLY_PHASE1)
- Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma (EARLY_PHASE1)
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:
- keto-amino acids CI brief — competitive landscape report
- keto-amino acids updates RSS · CI watch RSS
- YUAN Wei-jie portfolio CI