Lynkuet (elinzanetant) / Bayer - LARVOL DELTA

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=2400 | Not yet recruiting | Sponsor: Bayer | N=1500 ➔ 2400

Enrollment change • HEOR • Real-world evidence

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

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

Effect of elinzanetant on sleep disturbance and aspects of quality of life in women with breast cancer experiencing vasomotor symptoms: OASIS-4 subgroup analysis by type of endocrine therapy. (ASCO 2026) - "Mean change from baseline (BL) to week 12 in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) 8b total T-score (range 28.9–76.5; < 55 normal, 55– < 60 mild, 60– < 70 moderate, ≥70 severe) and Menopause-specific QoL questionnaire (MENQOL) total/domain scores (range 1–8; higher score indicates greater bother) were analyzed descriptively by ET type (tamoxifen [TAM], aromatase inhibitor [AI], ovarian function suppression [OFS], no OFS). In this post hoc analysis, EZN consistently improved sleep disturbance and menopause-related QoL, including vasomotor, psychosocial, physical and sexual aspects, across all ET subgroups. Taken with previous data, findings suggest to support the efficacy of EZN in reducing VMS, sleep disturbance and improving menopause-related QoL independently of ET type."

Clinical • HEOR • Breast Cancer • CNS Disorders • Oncology • Sleep Disorder • Solid Tumor • B3GAT1

MHRA authorises Lynkuet for hot flushes linked to breast cancer therapy (Pharmafile) - "The MHRA decision was based on results from the phase 3 OASIS-4 study, which evaluated elinzanetant in women with, or at high risk of developing, hormone-receptor-positive breast cancer experiencing vasomotor symptoms caused by adjuvant endocrine therapy."

MHRA approval • Hormone Receptor Positive Breast Cancer • Women's Health

Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Bayer

New P1 trial

The Drug Update: Recent drug approvals, summer 2026 edition. (PubMed, Nurse Pract) - "This article highlights the following new medications: brensocatib (Brinsupri), elinzanetant (Lynkuet), and zoliflodacin (Nuzolvence). Additionally, this article reviews newly approved indications for existing therapies, including finerenone (Kerendia) for heart failure with a left ventricular ejection fraction of >_ 40% and cyclobenzaprine hydrochloride sublingual tablets (Tonmya) for fibromyalgia."

Journal • Bronchiectasis • Cardiovascular • Congestive Heart Failure • Fibromyalgia • Heart Failure • Musculoskeletal Pain • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology

Consistency of efficacy and safety of elinzanetant for vasomotor symptoms and sleep disturbance associated with menopause across different populations: a review of the OASIS clinical trial program. (PubMed, Maturitas) - "Significant reductions vs. placebo were seen at week 12 in OASIS-1, -2, and -4 (key secondary endpoints; analyzed descriptively in OASIS-3 as a secondary endpoint). Elinzanetant was generally well tolerated with consistent efficacy across all OASIS trials in diverse populations of women experiencing vasomotor symptoms."

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

Elinzanetant improves sleep in postmenopausal women. So does placebo. (PubMed, Sleep) - No abstract available

Journal

Elinzanetant in postmenopausal women with sleep disturbance: results from the randomized, phase II NIRVANA study. (PubMed, Sleep) - P2 | "In this sleep-focused study, elinzanetant reduced WASO at Week 4 and led to estimated improvements in sleep continuity over 12 weeks, supported by multimodal subjective and objective sleep outcomes."

Journal • P2 data • CNS Disorders • Sleep Disorder • Women's Health

Elinzanetant improves sleep in postmenopausal women. So does placebo. (PubMed, Sleep) - No abstract available

Journal

Neurokinin 3 Receptor Antagonists for Menopause Symptom Management. (PubMed, Obstet Gynecol Clin North Am) - "Fezolinetant, a selective NK 3 receptor antagonist, and elinzanetant, a dual NK1/NK3 receptor antagonist, provide rapid and clinically meaningful reductions in VMS, with elinzanetant offering additional improvements in sleep. Both agents show favorable safety profiles, and elinzanetant is supported for use in women receiving endocrine therapy for breast cancer. Ongoing research explores broader applications in metabolic health and individualized therapy."

Journal • Review • Breast Cancer • Oncology • Solid Tumor

Neuroendocrine therapies. (PubMed, Post Reprod Health) - No abstract available

Journal

Elinzanetant for the Treatment of Menopausal Hot Flashes: A Plain Language Review of the OASIS-1-4 Clinical Trial Results. (PubMed, Womens Health (Lond)) - "Elinzanetant also improved their sleep and overall well-being. The side effects seen with elinzanetant were mainly mild and tolerable, the most common being headache, fatigue, and sleepiness.We use the term 'women' throughout for simplicity, but we recognize that menopause and its treatments may also be relevant to people who do not identify as women."

Clinical • Journal • Review • Breast Cancer • Fatigue • Oncology • Pain • Solid Tumor

Comparative Efficacy and Safety of Neurokinin Receptor Antagonists for Menopausal Vasomotor Symptoms: A Systematic Review and Meta-Analysis (ENDO 2026) - "In comparative evaluation, elinzanetant showed broader symptomatic benefits with rapid VMS relief and improvements in sleep and quality of life, whereas fezolinetant demonstrated favorable tolerability and safety, with a low overall risk of bias across included trials."

Retrospective data • Review • CNS Disorders • Sleep Disorder

EFFICACY OF ELINZANETANT FOR TREATMENT OF VASOMOTOR SYMPTOMS IN WOMEN WITH BREAST CANCER: SUBGROUP ANALYSIS OF OASIS-4 BY TYPE OF ENDOCRINE THERAPY (MASCC-ISOO 2026) - P3 | "Mean changes in daily moderate-to-severe VMS frequency and severity from baseline to weeks 1 (frequency only), 4, and 12 were analyzed by ET type (tamoxifen [TAM], aromatase inhibitor [AI], ovarian function suppression [OFS; i.e., gonadotropin-releasing hormone agonist], no OFS). Reductions in VMS frequency and severity were maintained throughout the 52-week treatment period. Conclusions Consistent with results in the overall population, EZN had greater reductions in VMS frequency and severity than PBO irrespective of the type of ET, with rapid onset and sustained effect over 52 weeks."

Clinical • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • B3GAT1

EFFICACY OF ELINZANETANT ACROSS DIFFERENT POPULATIONS OF WOMEN FROM FOUR PHASE III OASIS STUDIES (MASCC-ISOO 2026) - "Conclusions Elinzanetant reduced daily moderate-to-severe VMS frequency and severity, in addition to PROMIS SD SF 8b total T-scores, from baseline to week 12 to a greater extent than placebo in all four OASIS studies. These results suggest consistent efficacy across different populations of women, including those with a lower baseline symptom burden (OASIS-3) and those with VMS caused by ET for the treatment of breast cancer (OASIS-4)."

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

Recommendations for the Use of Non-Hormone Treatment of Vasomotor Symptoms of Menopause: Insights from a Modified Delphi Panel (ENDO 2026) - "Recommended first-line NHT options were SSRIs/SNRIs, gabapentin, and oxybutynin, after accounting for contraindications. Newly approved neurokinin targeted therapies (NKT), Fezolinetant, a neurokinin-3 receptor (NK-3R) antagonist and elinzanetant (dual NK-1R/NK-3R antagonist) were supported as first-line with high level evidence but limited by access and cost. Clonidine and most herbal/over-the-counter products were not recommended due to potential adverse effects, drug-drug interactions, or lack of evidence of benefit or harm...Conclusions This mDelphi panel provides structured, symptom- and comorbidity-based recommendations for NHT in VMS management. Findings extend existing guidelines by addressing real-world challenges and will support development of a Menopause Medical Eligibility Criteria (MenoMEC) tool to guide individualized, evidence-informed care."

Hepatology • Metabolic Disorders • Thrombosis

Comparative Efficacy and Safety of Neurokinin Receptor Antagonists for Menopausal Vasomotor Symptoms: A Systematic Review and Meta-Analysis (ENDO 2026) - "In comparative evaluation, elinzanetant showed broader symptomatic benefits with rapid VMS relief and improvements in sleep and quality of life, whereas fezolinetant demonstrated favorable tolerability and safety, with a low overall risk of bias across included trials."

Retrospective data • Review • CNS Disorders • Sleep Disorder

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 | Trial completion date: Jun 2029 ➔ Nov 2029 | Initiation date: Jun 2026 ➔ Nov 2026 | Trial primary completion date: Jun 2029 ➔ Nov 2029

HEOR • Real-world evidence • Trial completion date • Trial initiation date • Trial primary completion date

Neurokinin pathway antagonists for vasomotor symptoms in women with breast cancer: focus on elinzanetant and fezolinetant. (PubMed, Breast) - "Safety considerations of NK receptor antagonists include their use alongside CDK4/6 inhibitors. With breast cancer-specific data for elinzanetant and ongoing trials of fezolinetant, these agents will change clinical practice by improving symptom control and adherence to adjuvant endocrine therapy overall."

Journal • Review • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

FLASH-CV:: Finding Links Between Hot flASHes and CardioVascular Disease (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2030 ➔ Sep 2029 | Trial primary completion date: Oct 2029 ➔ Jun 2029

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular

Elinzanetant Is Effective for Vasomotor Symptoms Caused by Endocrine Therapy for Breast Cancer. (PubMed, Am Fam Physician) - No abstract available

Journal • Breast Cancer • Oncology • Solid Tumor

Neuro-hacking bone loss?: The Impact of Elinzanetant Treatment on Bone Health in Postmenopausal Women (ACOG 2026) - "Abstract is embargoed at this time."

Clinical • Osteoporosis

IW12. (IW12) Explore LYNKUET® (elinzanetant) 60mg capsules: An FDA Approved Treatment Option for Your Appropriate Patients (ACOG 2026) - "Supported by: Bayer. This session will provide an overview of LYNKUET's efficacy and safety profile, its mechanism of action, and how to access LYNKUET."

Clinical