{"id":"threonine","rwe":[],"_fda":{"id":"ed712a71-07a8-02bc-e053-2995a90a8c42","set_id":"1b8c8c83-1a46-4c0a-b883-e7dce781c5d1","openfda":{"upc":["0317089259183"],"unii":["I0IO929019","H0G9379FGK","O3B55K4YKI","97Z1WI3NDX","04Y7590D77","GMW67QNF9C","K3Z4F929H6","AE28F7PNPL","47E5O17Y3R","597RLJ09RG","2KBE35NE8S","2ZD004190S","8DUH1N11BX","HG18B9YRS7"],"route":["ORAL"],"spl_id":["ed712a71-07a8-02bc-e053-2995a90a8c42"],"brand_name":["OSTEOBIOS"],"spl_set_id":["1b8c8c83-1a46-4c0a-b883-e7dce781c5d1"],"package_ndc":["17089-259-18"],"product_ndc":["17089-259"],"generic_name":["CALCITONIN HUMAN - CALCIUM CARBONATE - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - ISOLEUCINE - LEUCINE - LYSINE - METHIONINE - PHENYLALANINE - SUS SCROFA BONE - SUS SCROFA PARATHYROID GLAND - THREONINE - TRYPTOPHAN - VALINE -"],"product_type":["HUMAN OTC DRUG"],"substance_name":["CALCITONIN HUMAN","CALCIUM CARBONATE","CALCIUM FLUORIDE","CALCIUM PHOSPHATE","ISOLEUCINE","LEUCINE","LYSINE","METHIONINE","PHENYLALANINE","SUS SCROFA BONE","SUS SCROFA PARATHYROID GLAND","THREONINE","TRYPTOPHAN","VALINE"],"manufacturer_name":["Guna spa"],"is_original_packager":[true]},"purpose":["USES Temporary relief of symptoms related weak bones such as: Frequent and slow-healing fractures Sharp and dull bone pain"],"version":"5","warnings":["WARNINGS Stop 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%"],"questions":["QUESTIONS Questions?: info@gunainc.com, tel. (484) 223-3500"],"effective_time":"20221114","active_ingredient":["ACTIVE INGREDIENTS/PURPOSE BONE 10X 30X 200X BONE FRACTURES CALCAREA FLUORICA 12X 30X 200X BONE FRACTURES CALCAREA CARBONICA 12X 30X 200X BONE FRACTURES CALCAREA PHOSPHORICA 12X 30X 200X BONE FRACTURES CALCITONIN 6X BONE FRACTURES PARATHYROID GLAND 10X 30X 200X IMPROVES BONE REPAIR"],"inactive_ingredient":["Inactive ingredient : Ethyl alcohol 30%."],"indications_and_usage":["Take 15 minutes before meals"],"dosage_and_administration":["DIRECTIONS 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"],"spl_product_data_elements":["OSTEOBIOS CALCITONIN HUMAN - CALCIUM CARBONATE - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - ISOLEUCINE - LEUCINE - LYSINE - METHIONINE - PHENYLALANINE - SUS SCROFA BONE - SUS SCROFA PARATHYROID GLAND - THREONINE - TRYPTOPHAN - VALINE - ALCOHOL CALCITONIN HUMAN CALCITONIN HUMAN ISOLEUCINE ISOLEUCINE LEUCINE LEUCINE LYSINE LYSINE METHIONINE METHIONINE PHENYLALANINE PHENYLALANINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN VALINE VALINE CALCIUM CARBONATE CALCIUM CATION CARBONATE ION CALCIUM FLUORIDE FLUORIDE ION CALCIUM PHOSPHATE CALCIUM CATION SUS SCROFA BONE SUS SCROFA BONE SUS SCROFA PARATHYROID GLAND SUS SCROFA PARATHYROID GLAND"],"pregnancy_or_breast_feeding":["PREGNANCY If pregnant or breast-feeding ask a doctor before use"],"keep_out_of_reach_of_children":["WARNINGS Keep out of reach of children"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 5USOST-REV05-03-04-18"]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Solution","category":"form"},{"label":"Active","category":"status"},{"label":"Nutritional support","category":"indication"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PARENTERAL NUTRITION ASSOCIATED LIVER DISEASE","source":"FDA FAERS","actionTaken":"50 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"42 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"39 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"36 reports"},{"date":"","signal":"CHILLS","source":"FDA FAERS","actionTaken":"35 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"35 reports"},{"date":"","signal":"NO ADVERSE EVENT","source":"FDA FAERS","actionTaken":"30 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"28 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"24 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"24 reports"}],"commonSideEffects":[],"contraindications":["Classical phenylketonuria"],"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":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=THREONINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:03:22.822040+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:03:28.275035+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:03:21.944910+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=THREONINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:03:28.640383+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:03:15.665203+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:03:15.665215+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:03:30.133439+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL291747/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:03:29.382251+00:00"}},"allNames":"threonin","offLabel":[],"synonyms":["L-Threonine","threonine","threonin","L-(-)-Threonine"],"timeline":[],"approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Threonin","ecosystem":[{"indication":"Nutritional support","otherDrugs":[{"name":"N-Acetyltyrosine","slug":"n-acetyltyrosine","company":""},{"name":"phosphoric acid","slug":"phosphoric-acid","company":"B Braun"},{"name":"sodium gluconate","slug":"sodium-gluconate","company":"Hospira"},{"name":"taurine","slug":"taurine","company":""}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Threonine is an essential amino acid that serves as a precursor for the synthesis of proteins and enzymes, including collagen, elastin, and keratin, which are critical for maintaining skin, hair, and muscle integrity."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4254","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=THREONINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=THREONINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:53:15.190824","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:03:31.501685+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"threonine","indications":{"approved":[{"name":"Nutritional support","source":"DrugCentral","snomedId":278906000,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06008093","phase":"PHASE2","title":"A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2024-04-04","conditions":["Carcinoma, Non-Small-Cell Lung"],"enrollment":100,"completionDate":"2027-12-23"},{"nctId":"NCT05768932","phase":"PHASE1","title":"BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"SillaJen, Inc.","startDate":"2022-12-14","conditions":["Advanced Solid Tumor","TNBC - 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