Leucine
/api/v1/drug/leucineIndications
Sourced from openFDA- Take 15 minutes before meals
Dosage & administration
Sourced from openFDADIRECTIONS Adults and children 12 years and older 20 drops in a little water, 2 times per day Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day Children under 6 years 5 drops in a glass of water, 2 times per day
Warnings & precautions
Sourced from openFDAStop use and ask doctor if symptoms persist more than 5 days. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Contains ethyl alcohol 30%
Approval history
Sourced from openFDA- Jul 20, 1984NDANDA019018B Braun
- Aug 23, 1984NDANDA018931Baxter Hlthcare
- Sep 6, 1985NDANDA019398Otsuka Icu Medcl
- Oct 17, 1986NDANDA019492Otsuka Icu Medcl
- Dec 19, 1991NDANDA020041Otsuka Icu Medcl
- Dec 19, 1991NDANDA020015Otsuka Icu Medcl
- Mar 26, 1997NDANDA020678Baxter Hlthcare
- Sep 29, 1997NDANDA020734Baxter Hlthcare
FAERS reports
- 1Parenteral Nutrition Associated Liver Disease507.1%
- 2Nausea446.2%
- 3Pyrexia405.6%
- 4Vomiting385.4%
- 5Chills354.9%
- 6Death354.9%
- 7Dyspnoea304.2%
- 8No Adverse Event304.2%
- 9Diarrhoea263.7%
- 10Asthenia243.4%
- 11Palpitations233.2%
- 12Pneumonia213.0%
- 13Pruritus213.0%
- 14Chest Discomfort202.8%
- 15General Physical Health Deterioration182.5%
Literature
Recent PubMed references pinned to Leucine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Leucine Promotes Mouse Primordial Follicle Activation Via the PI3K/Akt Signaling Pathway.Molecular reproduction and development · 2026 · Huang Y, Wei H, Zhang W, et al.PMID 42200771DOI 10.1002/mrd.70120
- APN Inhibitor Bestatin Induces MM Cell Differentiation Through the CD79B/BTK/STAT3 Pathway.Cells · 2026 · Wang X, Fang C, Li S, et al.PMID 42193957DOI 10.3390/cells15100949
- Synthesis of N-Acetyl-D- and -L-Leucine-(13)C(6) Tool Compounds in Neurodegenerative Disease.ChemMedChem · 2026 · Crepin D, McGown A, Shepherd D, et al.PMID 42140848DOI 10.1002/cmdc.70295
- Impact of leucine-rich diet on placenta's proteomic and metabolomic profiles of pregnant tumor-bearing rats.Cancer biology & therapy · 2026 · Dos Santos IF, Salgado CM, Carregari VC, et al.PMID 42135921DOI 10.1080/15384047.2026.2670792
- A bilayer carbohydrate hydrogel spatiotemporally modulates the leucine-mTORC1 axis in macrophages to orchestrate wound immunity and regeneration.Carbohydrate polymers · 2026 · Niu Z, Gong J, Xia X, et al.PMID 42067358DOI 10.1016/j.carbpol.2026.125336
- The olfactory receptor SNIF-1 mediates foraging for leucine-enriched diets in C. elegans.eLife · 2026 · Siddiqui R, Mehta N, Ranjith G, et al.PMID 42029136DOI 10.7554/eLife.101936
- Cav3.1 is a neuronal leucine sensor that mediates satiety and weight loss in response to dietary protein.Cell metabolism · 2026 · Tsang AH, Heeley N, Alcaino C, et al.PMID 42025169DOI 10.1016/j.cmet.2026.03.017
- Adding free leucine to a balanced essential amino acid mixture suppresses intracellular transamination of isoleucine and valine in healthy older adults.Clinical nutrition (Edinburgh, Scotland) · 2026 · Knezek SB, Engelen MPKJ, Coyle KS, et al.PMID 42013668DOI 10.1016/j.clnu.2026.106659
Clinical trials
The 10 most recently updated of 308 ClinicalTrials.gov registrations naming Leucine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's DiseaseRecruiting · Phase 2 · Interventional · 150 enrolled · Neuron23 Inc.NCT06680830updated 2026-06-09
- A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) EncephalitisRecruiting · Phase 3 · Interventional · 120 enrolled · Hoffmann-La RocheNCT05503264updated 2026-06-08
- A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung CancerRecruiting · Phase 2 · Interventional · 520 enrolled · Janssen Research & Development, LLCNCT05498428updated 2026-06-05
- Pivotal Study of N-acetyl-L-leucine for CACNA1ANot yet recruiting · Phase 3 · Interventional · 60 enrolled · IntraBio IncNCT07221292updated 2026-06-04
- Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease (PD) - Use Preclinical Human Trials to Confirm the Impact of the Optimal "Probiotic Y7, Tryptophan and Branched-chain Amino Acid" Cocktail Formula on Early Stage PD PatientsRecruiting · Interventional · 120 enrolled · Taipei Medical UniversityNCT07619560updated 2026-06-02
- Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean ContextRecruiting · Observational · 100 enrolled · Imelda GI Clinical Research CenterNCT07621783updated 2026-06-02
- SMART Diets for MASLDRecruiting · Phase 2 · Interventional · 102 enrolled · Michigan State UniversityNCT07459504updated 2026-06-01
- Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected TumorsRecruiting · Phase 1 · Interventional · 180 enrolled · Zai Lab (Shanghai) Co., Ltd.NCT07374848updated 2026-05-28
- Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory EpilepsyCompleted · Phase 1 · Interventional · 4 enrolled · Elizabeth Anne ThieleNCT06387186updated 2026-05-22
- RESvEraTrol in Parkinson's Disease (RESET)Not yet recruiting · Phase 2 · Interventional · 30 enrolled · Georgetown UniversityNCT07592767updated 2026-05-18
Frequently asked questions
- What is Leucine used for?
- According to FDA labeling, Leucine carries indications including: Take 15 minutes before meals. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What are the brand names for Leucine?
- Leucine is marketed under brand names including Aminosyn 10%, Sulfite-Free, Aminosyn 3.5 % M, Sulfite Free, Aminosyn 8.5 % with Electrolytes, Sulfite-Free, Aminosyn 8.5%, Sulfite-Free, Aminosyn II 10 %, Aminosyn II 15%, Aminosyn II 8.5 % with Electrolytes, Sulfite-Free, Aminosyn II 8.5 %, Sulfite-Free.
leucine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.