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L-Alanine (ALANINE)
L-Alanine is a marketed nutritional support product specifically indicated for infants and young children, currently holding a niche position in the pediatric nutrition market. Its key strength lies in its mechanism of action, which supports protein synthesis and energy production, essential for the growth and development of young patients. The primary risk to consider is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | ALANINE |
|---|---|
| Drug class | Amino Acid [EPC] |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Nutritional Support in Infants and Young Children
- Prevent Nitrogen and Weight Loss
Common side effects
- Nausea
- Pyrexia
- Hypertension
- Vomiting
- Hemoglobin decreased
- Protein total decreased
- Hypokalemia
- Blood potassium decreased
- Gamma-glutamyltransferase increased
- Hyperglycemia
- Blood alkaline phosphatase increased
- Blood calcium decreased
Key clinical trials
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (PHASE3)
- Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- Glutathione in Mild Cognitive Impairment (EARLY_PHASE1)
- Total Marrow and Lymphoid Irradiation, Fludarabine, and Melphalan Before Donor Stem Cell Transplant in Treating Participants With High-Risk Acute Leukemia or Myelodysplastic Syndrome (PHASE1)
- 30 Day Insulin Balance Metabolic Health Optimization Protocol (NA)
- An Investigational Scan (18F-DOPA PET/CT) for Improving the Clinical Management of Brain Tumors (PHASE2)
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-Alanine CI brief — competitive landscape report
- L-Alanine updates RSS · CI watch RSS