{"id":"leucine","rwe":[{"pmid":"41906977","year":"2026","title":"Coenzyme-Mediated Enantioselective Carboligation via Cross-β Amyloid Microphases.","finding":"","journal":"Journal of the American Chemical Society","studyType":"Clinical Study"},{"pmid":"41906791","year":"2026","title":"GWAS and genomic prediction of crown rust resistance in the southern US elite oat (Avena sativa L.) germplasm.","finding":"","journal":"The plant genome","studyType":"Clinical Study"},{"pmid":"41906303","year":"2026","title":"Discovery of Potent, Selective, CNS-Penetrant Macrocyclic LRRK2 Inhibitors for the Treatment of Parkinson's Disease.","finding":"","journal":"Journal of medicinal chemistry","studyType":"Clinical Study"},{"pmid":"41906238","year":"2026","title":"A hydrophobic core in the coiled-coil domain is essential for NRC resistosome function.","finding":"","journal":"The New phytologist","studyType":"Clinical Study"},{"pmid":"41904136","year":"2026","title":"Structural basis for pH-responsive amino acid transport via SLC7A4.","finding":"","journal":"Nature communications","studyType":"Clinical Study"}],"tags":[{"label":"leucine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Large neutral amino acids transporter small subunit 1","category":"target"},{"label":"SLC7A5","category":"gene"},{"label":"Intravenous","category":"route"},{"label":"Topical","category":"route"},{"label":"Injection","category":"form"},{"label":"Liquid","category":"form"},{"label":"Active","category":"status"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":67.383,"date":"","count":15,"signal":"Foetal growth restriction","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=67)"},{"llr":48.145,"date":"","count":10,"signal":"Device related sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=48)"}],"commonSideEffects":[{"effect":"Metabolic acidosis","drugRate":"reported","severity":"unknown"},{"effect":"Alkalosis","drugRate":"reported","severity":"unknown"},{"effect":"Osmotic diuresis and dehydration","drugRate":"reported","severity":"unknown"},{"effect":"Rebound hypoglycemia","drugRate":"reported","severity":"unknown"},{"effect":"Hypo- and hyper-vitaminosis","drugRate":"reported","severity":"unknown"},{"effect":"Pulmonary embolism due to pulmonary vascular precipitates","drugRate":"reported","severity":"unknown"},{"effect":"Hypersensitivity reactions","drugRate":"reported","severity":"unknown"},{"effect":"Risk of Infections","drugRate":"reported","severity":"unknown"},{"effect":"Refeeding syndrome","drugRate":"reported","severity":"unknown"},{"effect":"Hyperglycemia or hyperosmolar hyperglycemic state","drugRate":"reported","severity":"unknown"},{"effect":"Vein damage and thrombosis","drugRate":"reported","severity":"unknown"},{"effect":"Hepatobiliary disorders","drugRate":"reported","severity":"unknown"},{"effect":"Aluminum toxicity","drugRate":"reported","severity":"unknown"},{"effect":"Parenteral Nutrition Associated Liver Disease","drugRate":"reported","severity":"unknown"},{"effect":"Electrolyte imbalance and fluid overload","drugRate":"reported","severity":"unknown"},{"effect":"Pulmonary vascular emboli","drugRate":"reported","severity":"unknown"},{"effect":"Hyperglycemia and hyperosmolar hyperglycemic state","drugRate":"reported","severity":"unknown"},{"effect":"Vein thrombosis","drugRate":"reported","severity":"unknown"},{"effect":"Elevated liver function tests","drugRate":"reported","severity":"unknown"},{"effect":"Hyperammonemia","drugRate":"reported","severity":"unknown"},{"effect":"Electrolyte imbalances","drugRate":"reported","severity":"unknown"},{"effect":"Hypervolemia","drugRate":"reported","severity":"unknown"}],"contraindications":["Classical phenylketonuria","End stage renal disease","Heart disease","Humoral hypercalcemia of malignancy","Hypercalcemia","Hypercalciuria","Kidney disease","Kidney stone","Poisoning by digitalis glycoside","Sarcoidosis","Ventricular fibrillation"],"specialPopulations":{"Pregnancy":"Limited published data with injectable amino acids solutions, including PROSOL in pregnant women are not sufficient to inform drug associated risk for adverse developmental outcomes. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes. Parenteral nutrition should be considered if pregnant womans nutritional requirements cannot be fulfilled by oral or enteral intake. Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.","Geriatric use":"Clinical studies of CLINIMIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiopulmonary function, and of concomitant disease or other drug therapy.","Paediatric use":"Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes. Increased risk of hypoglycemia/hyperglycemia: monitor serum glucose concentrations."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"l-leucine","offLabel":[],"synonyms":["leucine","L-Leucine","Leu"],"timeline":[],"approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"L-Leucine","ecosystem":[],"mechanism":{"target":"Large neutral amino acids transporter small subunit 1","novelty":"First-in-class","targets":[{"gene":"SLC7A5","source":"DrugCentral","target":"Large neutral amino acids transporter small subunit 1","protein":"Large neutral amino acids transporter small subunit 1"}],"modality":"Small Molecule","drugClass":"leucine","explanation":"CLINIMIX is used as supplement of nutrition in patients, providing macronutrients (amino acids and dextrose) parenterally.The amino acids provide the structural units that make up proteins and are used to synthesize proteins and other biomolecules or are oxidized to urea and carbon dioxide as source of energy.The administered dextrose is oxidized to carbon dioxide and water, yielding energy.","oneSentence":"L-Leucine works by binding to a specific transporter in the body that helps regulate the uptake of amino acids.","technicalDetail":"L-Leucine targets the Large neutral amino acids transporter small subunit 1 (LAT1), a transmembrane protein that facilitates the uptake of large neutral amino acids into cells."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Leucine","title":"Leucine","extract":"Leucine or leucin (symbol Leu or L) is an essential amino acid that is used in the biosynthesis of proteins. Leucine is an α-amino acid, meaning it contains an α-amino group (which is in the protonated −NH3+ form under biological conditions), an α-carboxylic acid group (which is in the deprotonated −COO− form under biological conditions), and a side chain isobutyl group, making it a non-polar aliphatic amino acid. It is essential in humans, meaning the body cannot synthesize it; it must be obtained from the diet. Human dietary sources are foods that contain protein, such as meats, dairy products, soy products, and beans and other legumes. It is encoded by the codons UUA, UUG, CUU, CUC, CUA, and CUG. Leucine is named after the Greek word for 'white': λευκός (leukós 'white'), after its common appearance as a white powder, a property it shares with many other amino acids."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1557","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LEUCINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LEUCINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Leucine","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T12:17:54.216849","biosimilars":[],"competitors":[{"drugName":"gabapentin","drugSlug":"gabapentin","fdaApproval":"1993-12-30","genericCount":47,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"histidine","drugSlug":"histidine","fdaApproval":"","relationship":"same-target"},{"drugName":"levodopa","drugSlug":"levodopa","fdaApproval":"1970-06-04","patentExpiry":"Oct 21, 2033","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"phenylalanine","drugSlug":"phenylalanine","fdaApproval":"","relationship":"same-target"},{"drugName":"pregabalin","drugSlug":"pregabalin","fdaApproval":"2004-12-30","patentExpiry":"Nov 2, 2026","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"tyrosine","drugSlug":"tyrosine","fdaApproval":"","relationship":"same-target"},{"drugName":"valine","drugSlug":"valine","fdaApproval":"","relationship":"same-target"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"leucine","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"gabapentin","brandName":"gabapentin","genericName":"gabapentin","approvalYear":"1993","relationship":"same-target"},{"drugId":"histidine","brandName":"histidine","genericName":"histidine","approvalYear":"","relationship":"same-target"},{"drugId":"levodopa","brandName":"levodopa","genericName":"levodopa","approvalYear":"1970","relationship":"same-target"},{"drugId":"phenylalanine","brandName":"phenylalanine","genericName":"phenylalanine","approvalYear":"","relationship":"same-target"},{"drugId":"pregabalin","brandName":"pregabalin","genericName":"pregabalin","approvalYear":"2004","relationship":"same-target"},{"drugId":"tyrosine","brandName":"tyrosine","genericName":"tyrosine","approvalYear":"","relationship":"same-target"},{"drugId":"valine","brandName":"valine","genericName":"valine","approvalYear":"","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT07495592","phase":"NA","title":"The 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University","startDate":"2025-12-31","conditions":["Caries Active"],"enrollment":80,"completionDate":"2026-01-31"},{"nctId":"NCT04603443","phase":"NA","title":"SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2021-06-01","conditions":["Traumatic Brain Injury"],"enrollment":160,"completionDate":"2025-09-30"},{"nctId":"NCT04784234","phase":"NA","title":"Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin","status":"TERMINATED","sponsor":"Wills Eye","startDate":"2021-02-01","conditions":["Primary Open Angle Glaucoma"],"enrollment":12,"completionDate":"2022-10-27"},{"nctId":"NCT05485402","phase":"NA","title":"Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)","status":"COMPLETED","sponsor":"University Rovira i 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