Lynkuet (elinzanetant) / Bayer - LARVOL DELTA

Where do neurokinin receptor antagonists fit into management of menopausal vasomotor symptoms? (PubMed, JAAPA) - "To address this gap, nonhormonal therapies have been developed and investigated. Two newer options, fezolinetant and elinzanetant, directly target hypothalamic pathways involved in thermoregulation through modulation of neurokinin B. Clinical studies of these selective neurokinin B receptor antagonists demonstrate reduced frequency of vasomotor symptoms with their use, positioning them as promising options for individuals who are unable or unwilling to pursue hormone-based treatment."

Journal • Review

Efficacy and safety of elinzanetant for vasomotor symptoms associated with adjuvant endocrine therapy: Phase 3 OASIS 4 trial. (ASCO 2025) - P3 | "EZN was efficacious with a fast onset and well tolerated for the treatment of VMS associated with AET. TEAE frequency was as expected for this type of trial. Adequate VMS management can improve adherence to AET and, therefore, improve cancer outcomes and quality of life."

Clinical • P3 data • Breast Cancer • Fatigue • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Elinzanetant: A Novel Approach to Management of Vasomotor Menopausal Symptoms. (PubMed, Ann Pharmacother) - "The U.S. Food and Drug Administration approval of elinzanetant provides an additional nonhormonal option for managing moderate-to-severe VMS of menopause in patients for whom hormonal therapy is contraindicated or undesired."

Journal • Review • Breast Cancer • CNS Disorders • Fatigue • Oncology • Pain • Sleep Disorder • Solid Tumor

RELIEF: An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States (clinicaltrials.gov) - P=N/A | N=1500 | Not yet recruiting | Sponsor: Bayer

HEOR • New trial • Real-world evidence

Liver Safety of the Dual Neurokinin-1/-3 Receptor Antagonist Elinzanetant. (PubMed, Drug Saf) - "The aggregated phase 1‒3 clinical data, supported by preclinical toxicology and individual case adjudications of participants with elevated liver enzymes, suggest that there is a low risk of liver toxicity for elinzanetant. On the basis of these data, liver test monitoring was considered unnecessary in clinical practice by the LSMB (video abstract available online). Supplementary file2 (MP4 73923 KB)."

Journal • Hepatology • Liver Failure

Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. (PubMed, N Engl J Med) - P3 | "Elinzanetant led to a significantly lower frequency of vasomotor symptoms associated with endocrine therapy than placebo. (Funded by Bayer; OASIS-4 ClinicalTrials.gov number, NCT05587296.)."

Journal • Breast Cancer • Fatigue • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Pain • Solid Tumor

Comparative Efficacy of Elinzanetant Versus Other Non-Hormonal Pharmaceutical Therapies for the Treatment of Moderate-to-Severe Vasomotor Symptoms Associated With Menopause: A Network Meta-Analysis. (PubMed, BJOG) - "In this indirect comparison, elinzanetant showed superior or comparable efficacy to NKT or nHT in reducing the frequency and severity of VMS, along with improving sleep disturbances, supporting its role in VMS management."

Journal • Retrospective data • Review • CNS Disorders • Sleep Disorder

Efficacy of elinzanetant for the treatment of vasomotor symptoms in women with breast cancer: subgroup analysis of the OASIS-4 trial by type of endocrine therapy (EBCC 2026) - No abstract available

Clinical • Breast Cancer • Oncology • Solid Tumor

Safety and tolerability of elinzanetant: Pooled analysis from multiple clinical trials (ISGE 2026) - "Elinzanetant was well tolerated over 52 weeks, with low incidence of TEAEs and discontinuations. No concerning safety signals in hepatic, endometrial, metabolic, or bone parameters emerged. The most common TEAEs, headache and fatigue, were mild-to-moderate and mostly transient."

Retrospective data • Hepatology • Liver Failure • B3GAT1

AI-Driven Analysis of Exit Interviews from OASIS-1 and -2 Elinzanetant Clinical Trials: Novel Insights Beyond Traditional Endpoints (ISGE 2026) - "AI-driven analysis of 40 exit interviews from OASIS-1 & -2 revealed an overall positive experience in most women, highlighting experience with elinzanetant. In line with trial results, elinzanetant was shown to transform VMS, emotional well-being, cognitive and daily functioning translating into improved quality of life. Specific areas to improve trial logistics and womens' experiences were also identified."

Clinical • Interview

Consistency in effect of elinzanetant on wakefulness after sleep onset across subjective and objective measures: post hoc analysis of the Phase II NIRVANA pilot study (ISGE 2026) - "Elinzanetant demonstrated greater numerical reductions in WASO vs placebo across all modalities over the 12-week treatment period. This effect was consistent with the improvements in patient-reported sleep disturbances observed in prior OASIS trials. Previously presented at World Sleep 2025."

Clinical • P2 data • Retrospective data • CNS Disorders • Sleep Disorder

Effect of elinzanetant on VMS associated with natural menopause, surgical menopause, or endocrine therapy (ISGE 2026) - "Elinzanetant reduced VMS frequency and severity to a greater extent than placebo across women with VMS associated with natural menopause, surgical menopause, or ET. These results indicate that elinzanetant may be suitable for a broad population of women with menopause symptoms. Previously presented at TMS 2025."

Breast Cancer • Gynecology • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Solid Tumor

Efficacy of elinzanetant in VMS associated with endocrine therapy: subgroup analyses of the Phase III OASIS-4 trial (ISGE 2026) - "Conclusions Elinzanetant consistently demonstrated greater numerical reductions than placebo in moderate-to-severe VMS frequency in women taking ET for HR+ breast cancer across the analyzed BMI and smoking history subgroups. Previously presented at RCOG 2025."

Clinical • P3 data • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Solid Tumor

Efficacy of elinzanetant 120 mg across different populations of women from four phase 3 OASIS studies (ISGE 2026) - "Elinzanetant showed consistent efficacy across different populations of women, including those with a lower baseline VMS symptom burden (OASIS-3) and with VMS caused by ET (OASIS-4). Previously presented at TMS 2025."

Clinical • P3 data • Breast Cancer • CNS Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Sleep Disorder • Solid Tumor

Efficacy of elinzanetant for the treatment of vasomotor symptoms across subgroups: a pooled analysis of the Phase III OASIS-1 and -2 trials (ISGE 2026) - "The small sample size in the Hispanic/Latino subgroup limited interpretability of results (-1.0 [-4.7, 2.6]). Conclusions In this post hoc pooled analysis, elinzanetant numerically reduced VMS frequency vs placebo across most subgroups, demonstrating broad suitability for postmenopausal women."

P3 data • Retrospective data • Gynecology

Rapid sustained effects of elinzanetant for the treatment of VMS and sleep disturbances in postmenopausal women (ISGE 2026) - "Within one week, elinzanetant reduced VMS frequency and severity, and improved sleep disturbances. Effects were rapid and sustained over 28 weeks. After treatment cessation, symptoms partially returned but remained below baseline."

Clinical • CNS Disorders • Sleep Disorder

Elinzanetant: Efficacy and safety in the management of vasomotor symptoms in postmenopausal women, a systematic review and meta-analysis with grading of recommendations assessment, development, and evaluation assessment. (PubMed, Int J Gynaecol Obstet) - "Elinzanetant showed significant efficacy in reducing both the frequency and severity of VMSs associated with post-menopausal women at different time points, while concurrently improving outcomes associated with women's quality of life. While elinzanetant was associated with a higher incidence of non-serious adverse events such as headache, somnolence, and fatigue, which led to more treatment discontinuations, it did not increase the risk of serious adverse events compared to placebo, indicating an acceptable safety profile. Conclusively, our results indicate that elinzanetant represents a promising alternative for VMS management; however, it should not replace the clinical assessment of eligibility for hormone therapy. Further studies are required to confirm its long-term safety and sustained effectiveness."

Clinical • Journal • Retrospective data • Review • Fatigue • Pain • B3GAT1

FLASH-CV:: Finding Links Between Hot flASHes and CardioVascular Disease (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Massachusetts General Hospital | Initiation date: Jan 2026 ➔ Apr 2026

Trial initiation date • Cardiovascular

Expanding Nonhormonal Options for Menopausal Vasomotor Symptoms: Clinical Impact of Elinzanetant. (PubMed, Clin Ther) - No abstract available

Journal

Putting Theory into Practice by Developing a Novel Digital Health Technology-Derived Endpoint in Sleep Quality. (PubMed, Digit Biomark) - "Initial regulatory feedback from health authorities provided useful input and supported the study design on the incorporation of the DHT-derived endpoint into the clinical development program of elinzanetant...We outline how various stakeholders collaborated to leverage prior evidence, interacted with regulatory authority, and incorporated a novel DHT-derived endpoint into clinical development programs. Evidence and data generated in the present project have the potential to build the basis for further endpoint and DHT development and validation."

Journal • CNS Disorders • Sleep Disorder

Expression of Concern: Fezolinetant and Elinzanetant Therapy for Menopausal Women Experiencing Vasomotor Symptoms: A Systematic Review and Meta-Analysis. (PubMed, Obstet Gynecol) - No abstract available

Journal • Retrospective data

A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Bayer | Active, not recruiting ➔ Completed

Trial completion

The Major Advances of the Year in Breast Cancer: A Point of View After the ASCO 2025 Annual Meeting. (PubMed, Cancer Invest) - "In HR+ early BC, the SOFT/TEXT 15-year update confirmed the benefit of ovarian suppression plus endocrine therapy, while OASIS-4 showed elinzanetant reduced endocrine-related vasomotor symptoms. In early TNBC, NRG-BR003 found no survival benefit from adding carboplatin...In advanced disease, DESTINY-Breast09 established trastuzumab deruxtecan plus pertuzumab as superior first-line therapy. SERENA-6 and VERITAC-2 highlighted ESR1-targeted strategies, while ASCENT-04/KEYNOTE-D19 demonstrated sacituzumab govitecan plus pembrolizumab improved outcomes in PD-L1-positive advanced TNBC."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1

A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Bayer | Recruiting ➔ Active, not recruiting

Enrollment closed

LYNKUET® (elinzanetant). (PubMed, Clin Ther) - No abstract available

Journal