Lynkuet (elinzanetant) / Bayer - LARVOL DELTA

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

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

Journal

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

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

Fezolinetant compared with elinzanetant for the treatment of vasomotor symptoms associated with menopause: A matching-adjusted indirect comparison. (PubMed, Maturitas) - "MAIC analysis found that fezolinetant and elinzanetant had a similar efficacy profile for reduction of VMS frequency and severity. Differences in reduction of sleep disturbances did not result in differences in QoL. Neurokinin receptor antagonists provide an alternative to HT and other non-HT options for the treatment of VMS associated with menopause."

Journal • CNS Disorders • Sleep Disorder

Elinzanetant (Lynkuet) for menopausal vasomotor symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

OASIS-4: 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 (clinicaltrials.gov) - P3 | N=474 | Active, not recruiting | Sponsor: Bayer | Trial completion date: Jun 2027 ➔ Jun 2028

Trial completion date • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

▼Elinzanetant for menopause. (PubMed, Drug Ther Bull) - No abstract available

Journal • Review

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 | Recruiting | Sponsor: Bayer

New P1 trial

Elinzanetant: First Approval. (PubMed, Drugs) - "As a neurokinin-targeted therapy, elinzanetant modulates the activity of hyperactive kisspeptin/neurokinin B/dynorphin neurones to reduce the frequency and severity of VMS, which was demonstrated during the OASIS clinical trials. This article summarizes the milestones in the development of elinzanetant leading to this first approval for the treatment of moderate to severe VMS associated with menopause."

Journal

Psychometric Evaluation of the HFDD, PROMIS SD SF 8b, and MENQOL for Vasomotor Symptoms Caused by Endocrine Therapy: Reliability, Validity, and Differential Item Functioning (ISPOR-EU 2025) - P3 | "This study evaluated the psychometric properties of scores from the Hot Flash Daily Diary (HFDD), PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), and Menopause-Specific Quality of Life (MENQOL) in women experiencing VMS caused by ET. HFDD, PROMIS SD SF 8b, and MENQOL data collected at baseline and over 12 weeks was analyzed from a double-blind, randomized, placebo-controlled multicenter Phase 3 study of elinzanetant to treat VMS caused by ET (OASIS 4; NCT05587296)... Consistent with previous results in menopause, findings demonstrate that the HFDD, PROMIS SD SF 8b and MENQOL scores are valid and reliable, supporting their application in assessing clinical trial endpoints in women experiencing VMS caused by ET."

Breast Cancer • CNS Disorders • Sleep Disorder • Solid Tumor

EFFECT OF ELINZANETANT ON SLEEP IN AFICAN AMERICAN WOMEN: POOLED DATA FROM TWO PHASE 3 STUDIES (ASRM 2025) - No abstract available

Clinical • P3 data

US FDA approves Bayer's menopause relief drug (Reuters) - "Bayer said Lynkuet, a once-daily capsule to be taken at bedtime, is expected to be available in the U.S. beginning November...The drug's wholesale cost is $625 for a month's supply, though patient costs vary based on insurance, the company said. It has partnered with online pharmacy BlinkRx, through which eligible patients may pay as little as $25 a month via the Lynkuet Access, Savings and Support program....The FDA's approval for Lynkuet was based on three late-stage studies that showed the drug reduced the frequency and severity of hot flashes and eased sleep disturbances in menopausal women."

FDA approval • Launch US • Women's Health

Neurokinin Antagonists to Treat Vasomotor Symptoms-Possible Implications for Long-Term Health and Disease. (PubMed, J Clin Med) - "Recent evidence indicates that fezolinetant, a neurokinin-3 receptor antagonist and elinzanetant, a neurokinin-1-3 receptor antagonist, diminish the frequency and severity of vasomotor symptoms. The causal relation of symptoms with cortisol levels and oxidative stress, and the reduction in cortisol and blood pressure by symptom improvements, support the possibility that neurokinin antagonists may decrease those factors linking menopausal symptoms with cardiovascular disease and osteoporosis. Dedicated studies are needed to test the hypothetical possibility that neurokinin receptor antagonists contribute to reduce the long-term burden of cardiovascular disease and osteoporosis of symptomatic women in post-menopause unwilling or with contraindication to the use of menopause hormone therapy."

Journal • Cardiovascular • CNS Disorders • Depression • Hypotension • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Psychiatry • Rheumatology • Sleep Disorder

Practical considerations and emerging approaches for the management of vasomotor and sexual symptoms in breast cancer patients on endocrine therapies. (PubMed, Expert Rev Clin Pharmacol) - "Pharmacologic therapy for VMS has been centered on selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors, gabapentin, and clonidine...This review summarizes the current pharmacologic therapy for VMS, focusing on the practical considerations for use of the novel VMS (fezolinetant, elinzanetant) and libido agents (flibanserin, bremelanotide)...These novel agents are eagerly awaited therapeutic options; however, clinical trials excluded breast cancer patients. This review provides clinicians with relevant considerations to assess when recommending these therapies for patients with breast cancer, while awaiting ongoing research to give additional insights for best tailoring therapy for this patient population."

Journal • Review • Breast Cancer • Oncology • Solid Tumor

EFFICACY OF ELINZANETANT BY TIME SINCE MENOPAUSE: A POST HOC ANALYSIS OF THE OASIS-1 AND -2 CLINICAL TRIALS (FIGO 2025) - "Elinzanetant numerically improved VMS in both < 5 and ≥5-year subgroups of postmenopausal women, supporting its use regardless of time since menopause."

Clinical • Retrospective data • Gynecology • Women's Health

EFFICACY OF ELINZANETANT FOR NATURAL, SURGICAL, OR ENDOCRINE THERAPY ASSOCIATED MENOPAUSE SYMPTOMS (FIGO 2025) - "The efficacy demonstrated in OASIS-4 is considered similar to that in OASIS-1 and -2 indicating elinzanetant may be an effective treatment option for women with VMS associated with natural menopause or induced by surgery or endocrine therapy."

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

ISS02 Bayer: Navigating menopause: Exploring elinzanetant as a novel treatment option (FIGO 2025) - "Sponsored By Bayer"

Expert panel discussion: How does elinzanetant fit in the treatment landscape? (FIGO 2025) - "Sponsored By Bayer"

Elinzanetant: A new option for disruptive menopausal symptoms (FIGO 2025) - "Sponsored By Bayer"