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Synonyms: BAY-3427080 | BAY3427080 | Compound A [WO2021094247A1] | Example 34 [WO2007028654A1] | Lynkuet® | NT-814 | NT814
elinzanetant is an approved drug
Compound class:
Synthetic organic
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Summary of Clinical Use ![]() |
| Elinzanetant (BAY3427080) was progressed to clinical studies to evaluate its potential to treat vasomotor symptoms of the menopause (hot flushes/flashes, night sweats), and for women undergoing endocrine-based breast cancer therapy [2]. First approval was issued by the UK's MHRA in July 2025, to treat moderate to severe menopausal hot flushes and night sweats [3]. FDA approval for these symptoms followed in October 2025. Elinzanetant is also authorised for prescription in Australia, Canada and Switzerland. Contraindicated in patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, diltiazem, erythromycin, and verapamil) as these may reduce clearance of elinzanetant (daily dosage can be halved if required). CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, St. John's Wort) are likely to reduce elinzanetant exposure and efficacy. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT03596762 | A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms | Phase 2 Interventional | Bayer | The SWITCH-1 study. Positive results (decrease in VMS in postmenopausal women) were published in March 2023. | 7 |
| NCT02865538 | Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms | Phase 1/Phase 2 Interventional | Bayer | The RELENT-1 study. | 8 |
| NCT05042362 | 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 | Phase 3 Interventional | Bayer | OASIS-1 study | 4 |
| NCT05099159 | 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) | Phase 3 Interventional | Bayer | OASIS-2 study | 4 |
| NCT05030584 | 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 | Phase 3 Interventional | Bayer | OASIS-3 study | |
| NCT05587296 | 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 | Phase 3 Interventional | Bayer | OASIS-4 study | 2 |