{"id":"tibolone","rwe":[{"pmid":"41696755","year":"2026","title":"Menopausal hormone therapy and breast cancer: risk and management.","finding":"","journal":"Current opinion in obstetrics & gynecology","studyType":"Clinical Study"},{"pmid":"41672476","year":"2026","title":"Treatment patterns of hormone therapy for menopause-associated vasomotor symptoms: analysis of the HIRA database in South Korea.","finding":"","journal":"Climacteric : the journal of the International Menopause Society","studyType":"Clinical Study"},{"pmid":"41591384","year":"2026","title":"Association Between Menopausal Hormone Therapy and Cancer: A Nationwide Retrospective Cohort Study in South Korea.","finding":"","journal":"Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology","studyType":"Clinical Study"},{"pmid":"41490706","year":"2025","title":"Reappraising Cardiovascular Risks of Tibolone in Postmenopausal Women: A Response to the Editorial by Lee and Kim.","finding":"","journal":"Journal of menopausal medicine","studyType":"Clinical Study"},{"pmid":"41448220","year":"2025","title":"Menopause hormone therapy and risk of mild cognitive impairment or dementia: a systematic review and meta-analysis.","finding":"","journal":"The lancet. Healthy longevity","studyType":"Clinical Study"}],"tags":[{"label":"tibolone","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sodium-dependent serotonin transporter","category":"target"},{"label":"SLC6A4","category":"gene"},{"label":"ESR1","category":"gene"},{"label":"CYP2C19","category":"gene"},{"label":"G03CX01","category":"atc"},{"label":"Active","category":"status"},{"label":"Postmenopausal osteoporosis","category":"indication"},{"label":"Anabolic Agents","category":"pharmacology"},{"label":"Androgen Antagonists","category":"pharmacology"},{"label":"Antihypertensive Agents","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents, Hormonal","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Estrogen Receptor Modulators","category":"pharmacology"},{"label":"Hormone Antagonists","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"}],"phase":"discontinued","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"xyvion","offLabel":[],"synonyms":["tibolone","liviella","xyvion"],"timeline":[{"date":"1988-01-01","type":"positive","source":"DrugCentral","milestone":"YEAR INTRODUCED approval"}],"approvals":[{"date":"1988-01-01","orphan":false,"company":"","regulator":"YEAR INTRODUCED"}],"brandName":"Xyvion","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":"Sodium-dependent serotonin transporter","targets":[{"gene":"SLC6A4","source":"DrugCentral","target":"Sodium-dependent serotonin transporter","protein":"Sodium-dependent serotonin transporter"},{"gene":"ESR1","source":"DrugCentral","target":"Estrogen receptor","protein":"Estrogen receptor"},{"gene":"CYP2C19","source":"DrugCentral","target":"Cytochrome P450 2C19","protein":"Cytochrome P450 2C19"},{"gene":"AR","source":"DrugCentral","target":"Androgen receptor","protein":"Androgen receptor"},{"gene":"PGR","source":"DrugCentral","target":"Progesterone receptor","protein":"Progesterone receptor"},{"gene":"STS","source":"DrugCentral","target":"Steryl-sulfatase","protein":"Steryl-sulfatase"}],"modality":"Small Molecule","drugClass":"tibolone","explanation":"Think of serotonin as a chemical messenger that helps regulate mood, appetite, and sleep. When Xyvion binds to the sodium-dependent serotonin transporter, it can affect how much serotonin is available in the body, which may help alleviate symptoms of postmenopausal osteoporosis.","oneSentence":"Xyvion works by binding to the sodium-dependent serotonin transporter, which helps regulate serotonin levels in the body.","technicalDetail":"Xyvion's mechanism of action involves the inhibition of the sodium-dependent serotonin transporter (SERT), which is a key regulator of serotonin levels in the body. By binding to SERT, Xyvion can increase the availability of serotonin in the synaptic cleft, leading to its therapeutic effects."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2655","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TIBOLONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TIBOLONE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:54:33.469602","biosimilars":[],"competitors":[{"drugName":"amfetamine","drugSlug":"amfetamine","fdaApproval":"1955-09-09","relationship":"same-target"},{"drugName":"amiodarone","drugSlug":"amiodarone","fdaApproval":"1985-12-24","patentExpiry":"Mar 13, 2029","patentStatus":"Patent 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2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"amfetamine","brandName":"amfetamine","genericName":"amfetamine","approvalYear":"1955","relationship":"same-target"},{"drugId":"amiodarone","brandName":"amiodarone","genericName":"amiodarone","approvalYear":"1985","relationship":"same-target"},{"drugId":"amitriptyline","brandName":"amitriptyline","genericName":"amitriptyline","approvalYear":"1961","relationship":"same-target"},{"drugId":"amoxapine","brandName":"amoxapine","genericName":"amoxapine","approvalYear":"1980","relationship":"same-target"},{"drugId":"aripiprazole","brandName":"aripiprazole","genericName":"aripiprazole","approvalYear":"2002","relationship":"same-target"},{"drugId":"astemizole","brandName":"astemizole","genericName":"astemizole","approvalYear":"1988","relationship":"same-target"},{"drugId":"atomoxetine","brandName":"atomoxetine","genericName":"atomoxetine","approvalYear":"2002","relationship":"same-target"},{"drugId":"benzatropine","brandName":"benzatropine","genericName":"benzatropine","approvalYear":"1954","relationship":"same-target"},{"drugId":"benzethonium","brandName":"benzethonium","genericName":"benzethonium","approvalYear":"","relationship":"same-target"},{"drugId":"brexpiprazole","brandName":"brexpiprazole","genericName":"brexpiprazole","approvalYear":"2015","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT00725374","phase":"PHASE3","title":"A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-12-15","conditions":["Breast Cancer"],"enrollment":102,"completionDate":"2005-04-15"},{"nctId":"NCT00431431","phase":"PHASE4","title":"Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2000-07-31","conditions":["Osteopenia"],"enrollment":324,"completionDate":"2005-02-15"},{"nctId":"NCT05280028","phase":"","title":"HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness","status":"RECRUITING","sponsor":"Far Eastern Memorial Hospital","startDate":"2022-02-07","conditions":["Menopausal Syndrome"],"enrollment":100,"completionDate":"2026-12-31"},{"nctId":"NCT05568940","phase":"","title":"Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids","status":"WITHDRAWN","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2024-09","conditions":["Endometriosis","Fibroids"],"enrollment":0,"completionDate":"2026-04"},{"nctId":"NCT06117969","phase":"PHASE4","title":"the Effects of Different Therapy Regimens on Menopausal Sleep Disorders","status":"UNKNOWN","sponsor":"Peking Union Medical College Hospital","startDate":"2023-12-30","conditions":["Menopause","Sleep Disorder"],"enrollment":180,"completionDate":"2025-09-30"},{"nctId":"NCT05846698","phase":"","title":"The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill","status":"COMPLETED","sponsor":"Guoqing Zhou","startDate":"2017-07-01","conditions":["Climacteric Syndrome"],"enrollment":276,"completionDate":"2021-12-31"},{"nctId":"NCT01822288","phase":"PHASE4","title":"The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder","status":"COMPLETED","sponsor":"Far Eastern Memorial Hospital","startDate":"2012-11-16","conditions":["Menopausal Syndromes"],"enrollment":125,"completionDate":"2021-08-26"},{"nctId":"NCT00413764","phase":"PHASE3","title":"Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-03-23","conditions":["Sexual Dysfunction"],"enrollment":358,"completionDate":"2005-11-15"},{"nctId":"NCT00408863","phase":"PHASE3","title":"Livial Intervention Following Breast Cancer; Efficacy, Recurrence and Tolerability Endpoints (LIBERATE)(COMPLETED)(P05885)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-05","conditions":["Breast Cancer","Climacteric Symptoms"],"enrollment":3148,"completionDate":"2007-10"},{"nctId":"NCT00431093","phase":"PHASE4","title":"Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-11","conditions":["Menopause"],"enrollment":570,"completionDate":"2005-03"},{"nctId":"NCT00745108","phase":"PHASE3","title":"Tibolone Endometrium Study (Study 32972)(P06470)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-10-01","conditions":["Postmenopausal Women"],"enrollment":32,"completionDate":"2005-07-21"},{"nctId":"NCT00519857","phase":"PHASE3","title":"Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-07","conditions":["Osteoporosis"],"enrollment":4534,"completionDate":"2006-08"},{"nctId":"NCT02393482","phase":"PHASE4","title":"Psychological Impact of Amenorrhea in Women With Endometriosis","status":"UNKNOWN","sponsor":"University of Cagliari","startDate":"2021-06","conditions":["Amenorrhea","Endometriosis","Quality of Life"],"enrollment":50,"completionDate":"2022-06"},{"nctId":"NCT01470092","phase":"PHASE4","title":"Tibolone and Placebo in Adjunct to Antidepressant Medication for Women With Menopausal Depression","status":"COMPLETED","sponsor":"The Alfred","startDate":"2012-07","conditions":["Menopausal Depression"],"enrollment":120,"completionDate":"2017-12"},{"nctId":"NCT00735852","phase":"PHASE4","title":"Decapeptyl SR With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women","status":"COMPLETED","sponsor":"Sheffield Teaching Hospitals NHS Foundation Trust","startDate":"2008-12","conditions":["Endometriosis"],"enrollment":31,"completionDate":"2016-05"},{"nctId":"NCT02384408","phase":"PHASE4","title":"Hormone Replacement Therapy on the Postmenopausal Endometrium","status":"COMPLETED","sponsor":"Universidade do Vale do Sapucai","startDate":"2014-11","conditions":["Menopause"],"enrollment":100,"completionDate":"2015-07"},{"nctId":"NCT01543399","phase":"NA","title":"Vascular Effect of Tibolone in the Brachial Artery","status":"COMPLETED","sponsor":"Selmo Geber","startDate":"2012-03","conditions":["Menopause"],"enrollment":60,"completionDate":"2015-02"},{"nctId":"NCT01679795","phase":"NA","title":"Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery","status":"COMPLETED","sponsor":"Federal University of Minas Gerais","startDate":"2012-02","conditions":["Flow-mediated Dilation Evaluation of the Brachial Artery"],"enrollment":60,"completionDate":"2015-02"},{"nctId":"NCT01368068","phase":"PHASE4","title":"Investigation of Tibolone and Escitalopram in Perimenopausal Depression","status":"TERMINATED","sponsor":"The Alfred","startDate":"2012-07","conditions":["Perimenopausal 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University","startDate":"2008-03","conditions":["Endometriosis"],"enrollment":60,"completionDate":"2010-12"},{"nctId":"NCT00472004","phase":"PHASE4","title":"Study Comparing 17B Estradiol/TMG CC 1mg Vs. 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Healthy longevity"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Xyvion, also known as tibolone, is a small molecule drug that targets the sodium-dependent serotonin transporter. It is classified as a tibolone and has been approved for the treatment of postmenopausal osteoporosis. The commercial status of Xyvion is currently unknown, and it is not clear if it is patented or available as a generic medication. As a pharma professional, it is essential to consider the potential safety implications of Xyvion, although specific details are not available. Further research is necessary to fully understand the pharmacological properties of Xyvion.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"OTHER","regulator":"YEAR INTRODUCED","status":"approved","approval_date":"1988-01-01T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}