{"id":"nandrolone-decanoate","rwe":[{"pmid":"41616897","year":"2026","title":"N-acetyl-cysteine alleviates nandrolone decanoate-induced hippocampal cell apoptosis in rats via reversing protein expressions of S1P1, Akt and FOXO3a signaling pathway.","finding":"","journal":"Steroids","studyType":"Clinical Study"},{"pmid":"41505445","year":"2026","title":"Combined nandrolone and resistance training induced cardiac remodelling and oxidative stress despite enhanced cardiomyocyte contractility.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"41477377","year":"2025","title":"Nandrolone Decanoate for Postmenopausal Osteoporosis: A Systematic Review and Meta-Analysis of Randomized Trials.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"41261805","year":"2026","title":"Detection of Nandrolone Decanoate and Its Metabolites in Equine Hair After Intramuscular Administration.","finding":"","journal":"Drug testing and analysis","studyType":"Clinical Study"},{"pmid":"41242401","year":"2026","title":"Nandrolone decanoate induces liver damage via TGF-β/Smad3/miR-29 and regulation of FAT/CD36, PTP1B, HNF4A expression in male rats: Rescue effect of N-acetylcysteine.","finding":"","journal":"The Journal of steroid biochemistry and molecular biology","studyType":"Clinical Study"}],"tags":[{"label":"Androgen","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sex hormone-binding globulin","category":"target"},{"label":"SHBG","category":"gene"},{"label":"SERPINA6","category":"gene"},{"label":"SLC22A1","category":"gene"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Anemia in chronic kidney disease","category":"indication"},{"label":"Woodward Specl","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Anabolic Agents","category":"pharmacology"},{"label":"Androgens","category":"pharmacology"},{"label":"Bone Density Conservation Agents","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":161.18,"date":"","count":36,"signal":"Drug abuse","source":"DrugCentral FAERS","actionTaken":"Reported 36 times (LLR=161)"}],"commonSideEffects":[{"effect":"Acne","drugRate":"","severity":"common","organSystem":""},{"effect":"Hirsutism","drugRate":"","severity":"common","organSystem":""},{"effect":"Male pattern baldness","drugRate":"","severity":"common","organSystem":""},{"effect":"Deepening of voice in women","drugRate":"","severity":"common","organSystem":""},{"effect":"Gynecomastia","drugRate":"","severity":"common","organSystem":""},{"effect":"Edema","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"","severity":"common","organSystem":""},{"effect":"Depression","drugRate":"","severity":"common","organSystem":""},{"effect":"Excitation","drugRate":"","severity":"common","organSystem":""},{"effect":"Habituation","drugRate":"","severity":"common","organSystem":""},{"effect":"Clitoral enlargement","drugRate":"","severity":"common","organSystem":""},{"effect":"Menstrual irregularities","drugRate":"","severity":"common","organSystem":""},{"effect":"Testicular atrophy","drugRate":"","severity":"common","organSystem":""},{"effect":"Oligospermia","drugRate":"","severity":"common","organSystem":""},{"effect":"Impotence","drugRate":"","severity":"common","organSystem":""},{"effect":"Phallic enlargement","drugRate":"","severity":"common","organSystem":""},{"effect":"Increased frequency of erections","drugRate":"","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Hepatocellular neoplasms","drugRate":"","severity":"serious"},{"effect":"Peliosis hepatis","drugRate":"","severity":"serious"},{"effect":"Chronic priapism","drugRate":"","severity":"serious"},{"effect":"Testicular function inhibition","drugRate":"","severity":"serious"},{"effect":"Premature closure of epiphyses","drugRate":"","severity":"serious"},{"effect":"Decreased glucose tolerance","drugRate":"","severity":"serious"},{"effect":"Bleeding on concomitant anticoagulant therapy","drugRate":"","severity":"serious"},{"effect":"Epididymitis","drugRate":"","severity":"serious"},{"effect":"Bladder irritability","drugRate":"","severity":"serious"},{"effect":"Retention of serum electrolytes","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Woodward Specl","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=NANDROLONE DECANOATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:47:17.335497+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:47:24.203599+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NANDROLONE DECANOATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:47:25.039338+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Androgen Receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:47:25.739896+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200946/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:47:25.640357+00:00"}},"allNames":["durabolin","nandrolone decanoate","hybolin decanoate","norandrostenolone decanoate","nortestosterone decanoate"],"offLabel":[],"synonyms":["durabolin","nandrolone decanoate","hybolin decanoate","norandrostenolone decanoate","nortestosterone decanoate"],"timeline":[{"date":"1962-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ASPEN GLOBAL INC to Woodward Specl"},{"date":"1962-10-05","type":"positive","source":"DrugCentral","milestone":"FDA approval (Aspen Global Inc)"},{"date":"2010-08-30","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 4 manufacturers approved"}],"aiSummary":"Nandrolone Decanoate is an androgen medication originally developed by ASPEN GLOBAL INC and currently owned by Woodward Specl. It targets sex hormone-binding globulin and is used to treat anemia in chronic kidney disease. The drug is classified as a small molecule and was FDA-approved in 1962. Nandrolone Decanoate is available as a generic medication, with four generic manufacturers, and is off-patent. As an androgen, it plays a crucial role in the development and maintenance of male reproductive tissues and secondary sexual characteristics.","approvals":[{"date":"1962-10-05","orphan":false,"company":"ASPEN GLOBAL INC","regulator":"FDA"}],"brandName":"Nandrolone Decanoate","ecosystem":[{"indication":"Anemia in chronic kidney disease","otherDrugs":[{"name":"daprodustat","slug":"daprodustat","company":"Glaxosmithkline"},{"name":"epoetin alfa","slug":"epoetin-alfa","company":"Amgen"},{"name":"methoxy polyethylene glycol-epoetin beta","slug":"methoxy-polyethylene-glycol-epoetin-beta","company":"Hoffman-La Roche"},{"name":"peginesatide","slug":"peginesatide","company":"Takeda Pharms Usa"}],"globalPrevalence":850000000}],"mechanism":{"target":"Sex hormone-binding globulin","novelty":"Follow-on","targets":[{"gene":"SHBG","source":"DrugCentral","target":"Sex hormone-binding globulin","protein":"Sex hormone-binding globulin"},{"gene":"SERPINA6","source":"DrugCentral","target":"Corticosteroid-binding globulin","protein":"Corticosteroid-binding globulin"},{"gene":"SLC22A1","source":"DrugCentral","target":"Solute carrier family 22 member 1","protein":"Solute carrier family 22 member 1"},{"gene":"AR","source":"DrugCentral","target":"Androgen receptor","protein":"Androgen receptor"}],"modality":"Small Molecule","drugClass":"Androgen","explanation":"","oneSentence":"","technicalDetail":"Nandrolone Decanoate exerts its effects by binding to androgen receptors (AR), which are transcription factors that regulate gene expression. This binding causes a conformational change in the AR, allowing it to translocate to the nucleus and bind to specific DNA sequences, thereby influencing the transcription of target genes involved in muscle growth and development."},"commercial":{"launchDate":"1962","_launchSource":"DrugCentral (FDA 1962-10-05, ASPEN GLOBAL INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1881","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=NANDROLONE%20DECANOATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NANDROLONE DECANOATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T12:54:03.597895","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:47:27.687452+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"beclometasone dipropionate","drugSlug":"beclometasone-dipropionate","fdaApproval":"1976-05-12","relationship":"same-target"},{"drugName":"budesonide","drugSlug":"budesonide","fdaApproval":"1994-02-14","patentExpiry":"Sep 9, 2036","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"celecoxib","drugSlug":"celecoxib","fdaApproval":"1998-12-31","patentExpiry":"May 27, 2036","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"clobetasol propionate","drugSlug":"clobetasol-propionate","fdaApproval":"1985-12-27","patentExpiry":"Nov 5, 2028","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"clotrimazole","drugSlug":"clotrimazole","fdaApproval":"1975-02-03","patentExpiry":"May 26, 2042","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"danazol","drugSlug":"danazol","fdaApproval":"1976-06-21","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"desoximetasone","drugSlug":"desoximetasone","fdaApproval":"1977-02-28","patentExpiry":"Sep 1, 2028","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"dexamethasone","drugSlug":"dexamethasone","fdaApproval":"1958-10-30","patentExpiry":"Oct 7, 2036","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"dexamethasone phosphate","drugSlug":"dexamethasone-phosphate","fdaApproval":"1959-09-02","relationship":"same-target"},{"drugName":"diethylstilbestrol","drugSlug":"diethylstilbestrol","fdaApproval":"1973-05-30","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"}],"genericName":"nandrolone decanoate","indications":{"approved":[{"name":"Anemia in chronic kidney disease","source":"DrugCentral","snomedId":707323002,"regulator":"FDA","usPrevalence":37000000,"globalPrevalence":850000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet, 2023"}],"offLabel":[],"pipeline":[]},"currentOwner":"Woodward Specl","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"beclometasone-dipropionate","brandName":"beclometasone dipropionate","genericName":"beclometasone dipropionate","approvalYear":"1976","relationship":"same-target"},{"drugId":"budesonide","brandName":"budesonide","genericName":"budesonide","approvalYear":"1994","relationship":"same-target"},{"drugId":"celecoxib","brandName":"celecoxib","genericName":"celecoxib","approvalYear":"1998","relationship":"same-target"},{"drugId":"clobetasol-propionate","brandName":"clobetasol propionate","genericName":"clobetasol propionate","approvalYear":"1985","relationship":"same-target"},{"drugId":"clotrimazole","brandName":"clotrimazole","genericName":"clotrimazole","approvalYear":"1975","relationship":"same-target"},{"drugId":"danazol","brandName":"danazol","genericName":"danazol","approvalYear":"1976","relationship":"same-target"},{"drugId":"desoximetasone","brandName":"desoximetasone","genericName":"desoximetasone","approvalYear":"1977","relationship":"same-target"},{"drugId":"dexamethasone","brandName":"dexamethasone","genericName":"dexamethasone","approvalYear":"1958","relationship":"same-target"},{"drugId":"dexamethasone-phosphate","brandName":"dexamethasone phosphate","genericName":"dexamethasone phosphate","approvalYear":"1959","relationship":"same-target"},{"drugId":"diethylstilbestrol","brandName":"diethylstilbestrol","genericName":"diethylstilbestrol","approvalYear":"1973","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT06462482","phase":"PHASE4","title":"Peri-Operative Testosterone Administration in Primary Hip Arthroscopy","status":"NOT_YET_RECRUITING","sponsor":"American Hip Institute","startDate":"2025-01","conditions":["Femoro Acetabular Impingement"],"enrollment":60,"completionDate":"2026-12"},{"nctId":"NCT06608914","phase":"PHASE4","title":"Peri-Operative Testosterone Administration in Primary Total Hip Arthroplasty","status":"NOT_YET_RECRUITING","sponsor":"American Hip Institute","startDate":"2025-01","conditions":["Osteoarthritis, Hip"],"enrollment":60,"completionDate":"2026-12"},{"nctId":"NCT05978206","phase":"PHASE2","title":"Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet","status":"RECRUITING","sponsor":"National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland","startDate":"2023-08-10","conditions":["Sarcopenia"],"enrollment":168,"completionDate":"2026-10-30"},{"nctId":"NCT02055456","phase":"PHASE1,PHASE2","title":"Nandrolone Decanoate in the Treatment of Telomeropathies","status":"COMPLETED","sponsor":"University of Sao Paulo","startDate":"2014-02-01","conditions":["Aplastic Anemia","Bone Marrow Failure Syndromes","Idiopathic Pulmonary Fibrosis","Telomere Shortening"],"enrollment":20,"completionDate":"2017-02-01"},{"nctId":"NCT00673309","phase":"PHASE2,PHASE3","title":"Assessment of Mechanisms of Improved Wound Healing","status":"COMPLETED","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2000-07","conditions":["Burns"],"enrollment":644,"completionDate":"2013-04"},{"nctId":"NCT05805553","phase":"NA","title":"Anabolic Steroid and Propranolol in Paediatric Burn","status":"UNKNOWN","sponsor":"King Edward Medical University","startDate":"2020-12-01","conditions":["Arrest","Bone","Development","Growth"],"enrollment":114,"completionDate":"2023-09-28"},{"nctId":"NCT00000854","phase":"PHASE1","title":"A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":["HIV Infections","HIV Wasting Syndrome"],"enrollment":38,"completionDate":"2003-05"},{"nctId":"NCT03545347","phase":"PHASE2","title":"Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.","status":"COMPLETED","sponsor":"Morten Tange Kristensen PT, PhD","startDate":"2018-09-03","conditions":["Hip Fractures"],"enrollment":29,"completionDate":"2020-06-03"},{"nctId":"NCT00675714","phase":"PHASE2,PHASE3","title":"Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation","status":"TERMINATED","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2004-01","conditions":["Burns"],"enrollment":1126,"completionDate":"2019-07-15"},{"nctId":"NCT03263520","phase":"NA","title":"Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer","status":"COMPLETED","sponsor":"Hospital Erasto Gaertner","startDate":"2016-02","conditions":["Cachexia; Cancer"],"enrollment":60,"completionDate":"2017-10-31"},{"nctId":"NCT02376309","phase":"NA","title":"The Effect of Nandrolone Decanoate and Leucine on Muscle Loss","status":"COMPLETED","sponsor":"Maastricht University Medical Center","startDate":"2015-08","conditions":["Muscle Atrophy"],"enrollment":30,"completionDate":"2017-08"},{"nctId":"NCT00000597","phase":"PHASE3","title":"Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"1982-03","conditions":["Anemia, Aplastic","Hematologic Diseases","Pancytopenia","Blood Disease"],"enrollment":0,"completionDate":"1988-12"},{"nctId":"NCT00242463","phase":"PHASE2","title":"Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients","status":"TERMINATED","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","startDate":"2005-10","conditions":["Malnutrition","Critical Illness"],"enrollment":20,"completionDate":"2007-10"},{"nctId":"NCT00250536","phase":"NA","title":"Anabolic Steroids and Exercise in Hemodialysis Patients","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"2000-03","conditions":["End-Stage Renal Disease","Muscle Weakness"],"enrollment":80,"completionDate":"2004-10"},{"nctId":"NCT00682123","phase":"PHASE1,PHASE2","title":"Risk of Positive Doping Tests Following Ingestion of Supplements Contaminated With Trace Quantities of Nandrolone Metabolites","status":"COMPLETED","sponsor":"Loughborough University","startDate":"2006-03","conditions":["Positive Doping Tests in Sports"],"enrollment":20,"completionDate":"2006-09"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"crossReferences":{"NUI":"N0000179200","MMSL":"2095","NDDF":"001259","UNII":"H45187T098","VUID":"4018519","CHEBI":"CHEBI:7467","VANDF":"4018519","INN_ID":"295","RXNORM":"217575","UMLSCUI":"C0068395","chemblId":"CHEMBL1200946","ChEMBL_ID":"CHEMBL1200946","KEGG_DRUG":"D00955","DRUGBANK_ID":"DB08804","PUBCHEM_CID":"9677","SNOMEDCT_US":"126171003","MESH_DESCRIPTOR_UI":"D000077603","MESH_SUPPLEMENTAL_RECORD_UI":"C008580"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1962-","companyName":"Aspen Global Inc","relationship":"Original Developer"},{"period":"present","companyName":"Woodward Specl","relationship":"Current Owner"}],"publicationCount":624,"therapeuticAreas":["Hematology"],"biosimilarFilings":[],"originalDeveloper":"Aspen Global Inc","recentPublications":[{"date":"2026 Apr","pmid":"41616897","title":"N-acetyl-cysteine alleviates nandrolone decanoate-induced hippocampal cell apoptosis in rats via reversing protein expressions of S1P1, Akt and FOXO3a signaling pathway.","journal":"Steroids"},{"date":"2026","pmid":"41505445","title":"Combined nandrolone and resistance training induced cardiac remodelling and oxidative stress despite enhanced cardiomyocyte contractility.","journal":"PloS one"},{"date":"2025 Nov","pmid":"41477377","title":"Nandrolone Decanoate for Postmenopausal Osteoporosis: A Systematic Review and Meta-Analysis of Randomized Trials.","journal":"Cureus"},{"date":"2026 Jan","pmid":"41261805","title":"Detection of Nandrolone Decanoate and Its Metabolites in Equine Hair After Intramuscular Administration.","journal":"Drug testing and analysis"},{"date":"2026 Feb","pmid":"41242401","title":"Nandrolone decanoate induces liver damage via TGF-β/Smad3/miR-29 and regulation of FAT/CD36, PTP1B, HNF4A expression in male rats: Rescue effect of N-acetylcysteine.","journal":"The Journal of steroid biochemistry and molecular biology"}],"companionDiagnostics":[],"genericManufacturers":4,"_genericFilersChecked":true,"genericManufacturerList":["Abraxis Pharm","Am Regent","Epic Pharma Llc","Watson Labs"],"status":"approved","companyName":"Woodward Specl","companyId":"woodward-specl","modality":"Small molecule","firstApprovalDate":"1962","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1962-10-05T00:00:00.000Z","mah":"ASPEN GLOBAL INC","brand_name_local":null,"application_number":""},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"1962-10-05T00:00:00.000Z","mah":"ASPEN GLOBAL INC","brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"1962-10-05T00:00:00.000Z","mah":"ASPEN GLOBAL INC","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"1962-10-05T00:00:00.000Z","mah":"ASPEN GLOBAL INC","brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"1962-10-05T00:00:00.000Z","mah":"ASPEN GLOBAL INC","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"1962-10-05T00:00:00.000Z","mah":"ASPEN GLOBAL INC","brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":4,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:47:27.687452+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}