{"id":"aminoglutethimide","rwe":[{"pmid":"41173311","year":"2026","title":"Comparison of steroidogenic disruption in adrenal H295R and ovarian KGN and COV434 cell models and the implications to assess female reproductive toxicity.","finding":"","journal":"Reproductive toxicology (Elmsford, N.Y.)","studyType":"Clinical Study"},{"pmid":"41153881","year":"2025","title":"Effectiveness of Medical Treatment on Survivability in Canine Cushing's Syndrome: A Systematic Review and Meta-Analysis.","finding":"","journal":"Animals : an open access journal from MDPI","studyType":"Clinical Study"},{"pmid":"40958732","year":"2025","title":"Employing cancer driver genes for the identification of immunological features in two esophageal cancer subtypes to facilitate immunotherapy.","finding":"","journal":"Immunopharmacology and immunotoxicology","studyType":"Clinical Study"},{"pmid":"40576494","year":"2025","title":"Facile and Practical Synthesis of Substituted Piperidine-2,6-Diones Under Transition-Metal Free Condition.","finding":"","journal":"ChemistryOpen","studyType":"Clinical Study"},{"pmid":"40491360","year":"2025","title":"TFF3 Gene as a Molecular Target Potentially Shared by Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension: Drug Repurposing Prospect with Aminoglutethimide.","finding":"","journal":"Omics : a journal of integrative biology","studyType":"Clinical Study"}],"tags":[{"label":"Adrenal Steroid Synthesis Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Aromatase","category":"target"},{"label":"CYP19A1","category":"gene"},{"label":"TBXAS1","category":"gene"},{"label":"CYP11A1","category":"gene"},{"label":"L02BG01","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Secondary malignant neoplasm of female breast","category":"indication"},{"label":"Novartis","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents, Hormonal","category":"pharmacology"},{"label":"Aromatase Inhibitors","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Estrogen Antagonists","category":"pharmacology"},{"label":"Hormone Antagonists","category":"pharmacology"},{"label":"Steroid Synthesis Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"drugInteractions":[{"url":"/drug/tamoxifen","drug":"tamoxifen","action":"Monitor closely","effect":"May interact with Tamoxifen","source":"DrugCentral","drugSlug":"tamoxifen"}],"commonSideEffects":[],"contraindications":["Disease of liver","Hyperbilirubinemia","Hyperkalemia","Hypochloremia","Hypoglycemic disorder","Hyponatremia","Hypothyroidism","Infectious disease","Liver function tests abnormal","Low blood pressure","Pregnancy, function","Surgical procedure","Traumatic injury"]},"trials":[],"aliases":[],"company":"Novartis","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AMINOGLUTETHIMIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:22:39.139537+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:22:44.676545+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMINOGLUTETHIMIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:22:45.024420+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cytochrome P450 11A1 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:22:46.056041+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL488/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:22:45.715402+00:00"}},"allNames":"cytadren","offLabel":[],"synonyms":["aminoglutetimide","cytadren","aminoglutethimide","DL-Aminoglutethimide","orimeten"],"timeline":[{"date":"1980-10-29","type":"positive","source":"DrugCentral","milestone":"FDA approval (Novartis)"}],"aiSummary":"Cytadren (Aminoglutethimide) is a small molecule adrenal steroid synthesis inhibitor developed by Novartis, targeting aromatase to treat secondary malignant neoplasm of female breast. It was FDA approved in 1980 and remains a Novartis-owned product. Cytadren is off-patent, with no active Orange Book patents. As an inhibitor of adrenal steroid synthesis, it works by blocking the conversion of cholesterol to pregnenolone, a precursor to cortisol and other hormones. This mechanism ultimately reduces estrogen production, which can help slow the growth of hormone-sensitive breast cancer.","brandName":"Cytadren","ecosystem":[{"indication":"Secondary malignant neoplasm of female breast","otherDrugs":[{"name":"trastuzumab","slug":"trastuzumab","company":"Genentech"}],"globalPrevalence":685000}],"mechanism":{"target":"Aromatase","novelty":"Follow-on","targets":[{"gene":"CYP19A1","source":"DrugCentral","target":"Aromatase","protein":"Aromatase"},{"gene":"TBXAS1","source":"DrugCentral","target":"Thromboxane-A synthase","protein":"Thromboxane-A synthase"},{"gene":"CYP11A1","source":"DrugCentral","target":"Cholesterol side-chain cleavage enzyme, mitochondrial","protein":"Cholesterol side-chain cleavage enzyme, mitochondrial"}],"moaClass":"Adrenal Steroid Synthesis Inhibitors","modality":"Small Molecule","drugClass":"Adrenal Steroid Synthesis Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Cytadren inhibits the enzyme cholesterol desmolase, which is involved in the first step of adrenal steroid synthesis, thereby reducing the production of cortisol and other hormones, including estrogen, which is a key factor in the growth of hormone-sensitive breast cancer."},"commercial":{"launchDate":"1980","_launchSource":"DrugCentral (FDA 1980-10-29, NOVARTIS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/164","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AMINOGLUTETHIMIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMINOGLUTETHIMIDE","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":"2026-03-30T08:41:01.443110","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:22:47.259184+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"anastrozole","drugSlug":"anastrozole","fdaApproval":"1995-12-27","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"letrozole","drugSlug":"letrozole","fdaApproval":"1997-07-25","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"exemestane","drugSlug":"exemestane","fdaApproval":"1999-10-21","genericCount":11,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"aminoglutethimide","indications":{"approved":[{"name":"Secondary malignant neoplasm of female breast","source":"DrugCentral","snomedId":94297009,"regulator":"FDA","usPrevalence":null,"globalPrevalence":685000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Oncology, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"anastrozole","brandName":"anastrozole","genericName":"anastrozole","approvalYear":"1995","relationship":"same-class"},{"drugId":"letrozole","brandName":"letrozole","genericName":"letrozole","approvalYear":"1997","relationship":"same-class"},{"drugId":"exemestane","brandName":"exemestane","genericName":"exemestane","approvalYear":"1999","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT00309491","phase":"PHASE3","title":"Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients","status":"COMPLETED","sponsor":"Austrian Breast & Colorectal Cancer Study Group","startDate":"1990-12","conditions":["Early-stage Breast Cancer"],"enrollment":2021,"completionDate":"2000-03"},{"nctId":"NCT00006371","phase":"PHASE2","title":"A Phase II Trial of Early Medical Adrenalectomy for \"D0.5\" Prostate Cancer","status":"TERMINATED","sponsor":"H. 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