{"id":"lasofoxifene","rwe":[{"pmid":"40742784","year":"2025","title":"Comparison of estrogens and selective estrogen receptor modulators (SERMs) used for menopausal hormone therapy.","finding":"","journal":"Menopause (New York, N.Y.)","studyType":"Clinical Study"},{"pmid":"40518539","year":"2025","title":"PARP-1 as a novel target in endocrine-resistant breast cancer.","finding":"","journal":"Journal of experimental & clinical cancer research : CR","studyType":"Clinical Study"},{"pmid":"40222048","year":"2025","title":"ELAINE 3: phase 3 study of lasofoxifene plus abemaciclib to treat ER+/HER2-, ESR1-mutated, metastatic breast cancer.","finding":"","journal":"Future oncology (London, England)","studyType":"Clinical Study"},{"pmid":"39828494","year":"2025","title":"Effects of Lasofoxifene Versus Fulvestrant on Vaginal and Vulvar Symptoms in Patients With ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer From the ELAINE 1 Study.","finding":"","journal":"Clinical breast cancer","studyType":"Clinical Study"},{"pmid":"39610216","year":"2024","title":"Discovery of Thiochroman Derivatives as Potent, Oral Selective Estrogen Receptor Degraders and Antagonists for the Treatment of Endocrine-Resistant Breast Cancer.","finding":"","journal":"Journal of medicinal chemistry","studyType":"Clinical Study"}],"tags":[{"label":"lasofoxifene","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Estrogen receptor","category":"target"},{"label":"ESR1","category":"gene"},{"label":"ESR2","category":"gene"},{"label":"G03XC03","category":"atc"},{"label":"Active","category":"status"},{"label":"Postmenopausal osteoporosis","category":"indication"},{"label":"Dr. Friedrich Eberth Arzneimittel GmbH","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"Dr. Friedrich Eberth Arzneimittel GmbH","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=LASOFOXIFENE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:13:41.911591+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:13:48.761525+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:13:41.933091+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LASOFOXIFENE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:13:49.569007+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Estrogen receptor modulator","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:13:50.309505+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6067998/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:13:50.116363+00:00"}},"allNames":"fablyn","offLabel":[],"synonyms":["lasofoxifene","lasofoxifene tartrate","fablyn","CP-336156","CP-336,156"],"timeline":[{"date":"2009-02-24","type":"positive","source":"DrugCentral","milestone":"EMA approval (Dr. Friedrich Eberth Arzneimittel GmbH)"}],"approvals":[{"date":"2009-02-24","orphan":false,"company":"Dr. Friedrich Eberth Arzneimittel GmbH","regulator":"EMA"}],"brandName":"Fablyn","ecosystem":[{"indication":"Postmenopausal osteoporosis","otherDrugs":[{"name":"alendronic acid","slug":"alendronic-acid","company":"Merck And Co Inc"},{"name":"bazedoxifene","slug":"bazedoxifene","company":"Wyeth Pharms Pfizer"},{"name":"calcitonin (salmon synthetic)","slug":"calcitonin-(salmon-synthetic)","company":"Sanofi Aventis Us"},{"name":"calcium citrate","slug":"calcium-citrate","company":""}],"globalPrevalence":200000000}],"mechanism":{"target":"Estrogen receptor","targets":[{"gene":"ESR1","source":"DrugCentral","target":"Estrogen receptor","protein":"Estrogen receptor"},{"gene":"ESR2","source":"DrugCentral","target":"Estrogen receptor beta","protein":"Estrogen receptor beta"}],"modality":"Small Molecule","drugClass":"lasofoxifene","explanation":"","oneSentence":"","technicalDetail":"Fablyn (Lasofoxifene) is a selective estrogen receptor modulator (SERM) that binds to estrogen receptors, activating them in some tissues and blocking them in others, thereby exerting its anabolic effects on bone and its anti-estrogenic effects on breast and uterus."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4308","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LASOFOXIFENE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LASOFOXIFENE","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T14:04:48.297548","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:13:52.121838+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"raloxifene","drugSlug":"raloxifene","fdaApproval":"1997-12-09","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"bazedoxifene","drugSlug":"bazedoxifene","fdaApproval":"2013-10-03","relationship":"same-class"},{"drugName":"ospemifene","drugSlug":"ospemifene","fdaApproval":"2013-02-26","patentExpiry":"Jul 9, 2028","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"lasofoxifene","indications":{"approved":[{"name":"Postmenopausal osteoporosis","source":"DrugCentral","snomedId":102447009,"regulator":"FDA","usPrevalence":10000000,"globalPrevalence":200000000,"prevalenceMethod":"curated","prevalenceSource":"IOF, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"raloxifene","brandName":"raloxifene","genericName":"raloxifene","approvalYear":"1997","relationship":"same-class"},{"drugId":"bazedoxifene","brandName":"bazedoxifene","genericName":"bazedoxifene","approvalYear":"2013","relationship":"same-class"},{"drugId":"ospemifene","brandName":"ospemifene","genericName":"ospemifene","approvalYear":"2013","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01042379","phase":"PHASE2","title":"I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","status":"RECRUITING","sponsor":"QuantumLeap Healthcare Collaborative","startDate":"2010-03-01","conditions":["Breast Neoplasms","Breast Cancer","Breast Tumors","Angiosarcoma","TNBC - Triple-Negative Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer"],"enrollment":5000,"completionDate":"2031-12"},{"nctId":"NCT03781063","phase":"PHASE2","title":"Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","status":"COMPLETED","sponsor":"Sermonix Pharmaceuticals Inc.","startDate":"2019-09-20","conditions":["Locally Advanced or Metastatic Breast Cancer"],"enrollment":100,"completionDate":"2025-05-08"},{"nctId":"NCT05696626","phase":"PHASE3","title":"Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","status":"RECRUITING","sponsor":"Sermonix Pharmaceuticals Inc.","startDate":"2023-10-31","conditions":["Metastatic Breast Cancer"],"enrollment":500,"completionDate":"2028-04"},{"nctId":"NCT06197568","phase":"PHASE1,PHASE2","title":"Open-Label Study of Vaginal AZU-101 in Postmenopausal Women","status":"NOT_YET_RECRUITING","sponsor":"Azure Biotech Inc.","startDate":"2026-05-01","conditions":["Postmenopausal Symptoms"],"enrollment":35,"completionDate":"2027-06-30"},{"nctId":"NCT04432454","phase":"PHASE2","title":"Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","status":"COMPLETED","sponsor":"Sermonix Pharmaceuticals Inc.","startDate":"2020-09-29","conditions":["Metastatic Breast Cancer"],"enrollment":29,"completionDate":"2025-01-28"},{"nctId":"NCT00141323","phase":"PHASE3","title":"Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)","status":"COMPLETED","sponsor":"Ligand Pharmaceuticals","startDate":"2001-11","conditions":["Osteoporosis"],"enrollment":8556,"completionDate":"2007-12"},{"nctId":"NCT00163137","phase":"PHASE3","title":"Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss","status":"COMPLETED","sponsor":"Ligand Pharmaceuticals","startDate":"2003-05","conditions":["Osteoporosis"],"enrollment":540,"completionDate":"2005-10"},{"nctId":"NCT00674453","phase":"PHASE2","title":"The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation","status":"COMPLETED","sponsor":"Ligand Pharmaceuticals","startDate":"2004-09","conditions":["Bone Loss"],"enrollment":51,"completionDate":"2007-09"},{"nctId":"NCT00143273","phase":"PHASE2","title":"Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation","status":"COMPLETED","sponsor":"Ligand Pharmaceuticals","startDate":"2004-06","conditions":["Osteoporosis"],"enrollment":497,"completionDate":"2006-03"}],"_emaApprovals":[{"date":"2009-02-24","status":"Authorised","company":"Dr. Friedrich Eberth Arzneimittel GmbH"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"337G83N988","CHEBI":"CHEBI:135938","INN_ID":"7875","UMLSCUI":"C0963839","chemblId":"CHEMBL6067998","ChEMBL_ID":"CHEMBL328190","KEGG_DRUG":"D04672","DRUGBANK_ID":"DB06202","PDB_CHEM_ID":" C3D","PUBCHEM_CID":"216416","IUPHAR_LIGAND_ID":"7542","SECONDARY_CAS_RN":"190791-29-8","MESH_SUPPLEMENTAL_RECORD_UI":"C111332"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Dr. Friedrich Eberth Arzneimittel GmbH","relationship":"Original Developer"}],"publicationCount":168,"therapeuticAreas":["Bone"],"atcClassification":{"source":"DrugCentral","atcCode":"G03XC03","allCodes":["G03XC03"]},"biosimilarFilings":[],"originalDeveloper":"Dr. Friedrich Eberth Arzneimittel GmbH","recentPublications":[{"date":"2025 Aug 1","pmid":"40742784","title":"Comparison of estrogens and selective estrogen receptor modulators (SERMs) used for menopausal hormone therapy.","journal":"Menopause (New York, N.Y.)"},{"date":"2025 Jun 16","pmid":"40518539","title":"PARP-1 as a novel target in endocrine-resistant breast cancer.","journal":"Journal of experimental & clinical cancer research : CR"},{"date":"2025 May","pmid":"40222048","title":"ELAINE 3: phase 3 study of lasofoxifene plus abemaciclib to treat ER+/HER2-, ESR1-mutated, metastatic breast cancer.","journal":"Future oncology (London, England)"},{"date":"2025 Apr","pmid":"39828494","title":"Effects of Lasofoxifene Versus Fulvestrant on Vaginal and Vulvar Symptoms in Patients With ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer From the ELAINE 1 Study.","journal":"Clinical breast cancer"},{"date":"2024 Dec 12","pmid":"39610216","title":"Discovery of Thiochroman Derivatives as Potent, Oral Selective Estrogen Receptor Degraders and Antagonists for the Treatment of Endocrine-Resistant Breast Cancer.","journal":"Journal of medicinal chemistry"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Dr. Friedrich Eberth Arzneimittel GmbH","companyId":"dr-friedrich-eberth-arzneimittel-gmbh","modality":"Small molecule","firstApprovalDate":"2009","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":3,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:13:52.121838+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}