Last reviewed · How we verify
L-Lysine (LYSINE)
At a glance
| Generic name | LYSINE |
|---|---|
| Sponsor | Advanced Accelerator Applications |
| Drug class | lysine |
| Target | Glutathione reductase, mitochondrial |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Itchy skin
- Painful skin
- Red skin
- Irritated skin
- Anxiousness
- Diarrhea
- Indigestion
Common side effects
- Sepsis
- Anemia
- Total Bleeding
- Intraventricular Hemorrhage, All Grades
- Apnea
- Gastrointestinal Disorders
- Total Renal Events
- Respiratory Infection
- Skin Lesion/Irritation
- Intraventricular Hemorrhage, Grades 1/2
- Intraventricular Hemorrhage, Grades 3/4
- Hypoglycemia
Serious adverse events
- Gastrointestinal Perforation
- Necrotizing Enterocolitis
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Pulmonary Hypertension
- Cardiac Failure
- Renal Failure
- Convulsions
- Hypotension
- Cholestasis
- Inguinal Hernia
Key clinical trials
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer (PHASE1,PHASE2)
- A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients (PHASE1,PHASE2)
- Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (PHASE2)
- Essential Amino Acids and Parkinsons Disease (PHASE1)
- Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer (PHASE1)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer (PHASE1,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-Lysine CI brief — competitive landscape report
- L-Lysine updates RSS · CI watch RSS
- Advanced Accelerator Applications portfolio CI