{"id":"elinzanetant-bay3427080","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL4802157","moleculeType":"Small molecule","molecularWeight":"668.65"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug selectively antagonizes the NK3 receptor, which plays a key role in thermoregulation and the pathophysiology of hot flashes and night sweats. By blocking NK3 receptor signaling in the central nervous system, elinzanetant suppresses the neuronal circuits responsible for vasomotor instability associated with menopause. This mechanism offers a non-hormonal approach to managing menopausal symptoms.","oneSentence":"Elinzanetant is a neurokinin-3 (NK3) receptor antagonist that reduces vasomotor symptoms by blocking neurokinin signaling in the hypothalamus.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:10:40.843Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Vasomotor symptoms (hot flashes and night sweats) associated with menopause"}]},"trialDetails":[{"nctId":"NCT05042362","phase":"PHASE3","title":"A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-08-27","conditions":"Vasomotor Symptoms Associated With Menopause, Hot Flashes","enrollment":396},{"nctId":"NCT05099159","phase":"PHASE3","title":"A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-10-29","conditions":"Vasomotor Symptoms Associated With Menopause, Hot Flashes","enrollment":400},{"nctId":"NCT05587296","phase":"PHASE3","title":"A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bayer","startDate":"2022-10-14","conditions":"Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes","enrollment":474},{"nctId":"NCT07229404","phase":"PHASE1","title":"A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants","status":"COMPLETED","sponsor":"Bayer","startDate":"2025-11-05","conditions":"Vasomotor Symptoms","enrollment":18},{"nctId":"NCT05030584","phase":"PHASE3","title":"A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-08-27","conditions":"Vasomotor Symptoms Associated With Menopause, Hot Flashes","enrollment":628},{"nctId":"NCT05071729","phase":"PHASE1","title":"A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-10-14","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","enrollment":31},{"nctId":"NCT06219902","phase":"PHASE1","title":"A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women","status":"COMPLETED","sponsor":"Bayer","startDate":"2024-01-08","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes","enrollment":64},{"nctId":"NCT04889287","phase":"PHASE1","title":"A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-05-26","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","enrollment":16},{"nctId":"NCT04845841","phase":"PHASE1","title":"Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-04-09","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","enrollment":16},{"nctId":"NCT05481528","phase":"PHASE1","title":"A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-08-19","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers","enrollment":51},{"nctId":"NCT03596762","phase":"PHASE2","title":"A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms","status":"COMPLETED","sponsor":"Bayer","startDate":"2018-11-20","conditions":"Menopause, Hot Flashes, Night Waking","enrollment":199},{"nctId":"NCT05471817","phase":"PHASE1","title":"A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-08-05","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers","enrollment":20},{"nctId":"NCT05381142","phase":"PHASE1","title":"A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-05-23","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers","enrollment":16},{"nctId":"NCT05351892","phase":"PHASE1","title":"A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants","status":"COMPLETED","sponsor":"Bayer","startDate":"2022-05-04","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers","enrollment":18},{"nctId":"NCT04981431","phase":"PHASE1","title":"A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-08-11","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","enrollment":62},{"nctId":"NCT04903821","phase":"PHASE1","title":"A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-06-01","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","enrollment":33},{"nctId":"NCT05061563","phase":"PHASE1","title":"A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-09-30","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes","enrollment":14},{"nctId":"NCT05028608","phase":"PHASE1","title":"A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.","status":"COMPLETED","sponsor":"Bayer","startDate":"2021-09-06","conditions":"Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","enrollment":16},{"nctId":"NCT04654897","phase":"PHASE1","title":"Mass Balance Study of [14C]-NT-814 Oral Suspension in Healthy Male Subjects","status":"COMPLETED","sponsor":"Bayer","startDate":"2020-09-30","conditions":"Healthy","enrollment":6}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["NT-814"],"phase":"phase_3","status":"active","brandName":"Elinzanetant (BAY3427080)","genericName":"Elinzanetant (BAY3427080)","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Elinzanetant is a neurokinin-3 (NK3) receptor antagonist that reduces vasomotor symptoms by blocking neurokinin signaling in the hypothalamus. Used for Vasomotor symptoms (hot flashes and night sweats) associated with menopause.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}