Lynkuet (elinzanetant) / Bayer - LARVOL DELTA

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"

Advances in Pharmacotherapy for Menopausal Vasomotor Symptoms. (PubMed, Drugs) - "Fezolinetant (NK3 receptor antagonist) and the newly approved elinzanetant (NK1 and NK3 receptor antagonist) are non-hormonal treatment options approved for the treatment of VMS associated with menopause. A number of investigational agents are currently in phase 2 trials for potential future use for VMS; these include Q-122, PhytoSERM, NOE-115, GS1-144, and HS-10384. In this review, we highlight the recent advancements in our understanding of the pathophysiology of VMS and consider the current, new, and investigational treatment options for the treatment of VMS."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Coronary Artery Disease • Heart Failure • Sleep Disorder

On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lynkuet, intended for the treatment of moderate to severe vasomotor symptoms (hot flushes). (European Medicines Agency) - "Lynkuet is indicated for the treatment of moderate to severe vasomotor symptoms (VMS): associated with menopause; caused by adjuvant endocrine therapy (AET) related to breast cancer."

CHMP • Women's Health

Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. (PubMed, JAMA Intern Med) - P3 | "Elinzanetant shows promise as a treatment for moderate to severe VMS. ClinicalTrials.gov Identifier: NCT05030584."

Clinical • Journal • P3 data • CNS Disorders • Fatigue • Pain • Sleep Disorder

The Growing Promise of Elinzanetant for Treatment of Menopausal Symptoms-Sustained Relief Without Hormones. (PubMed, JAMA Intern Med) - No abstract available

Journal

Effect of elinzanetant on wakefulness after sleep onset across subjective and objective measures: post hoc analysis of the NIRVANA phase 2 pilot study in postmenopausal women with sleep disturbances (WSS 2025) - "NIRVANA is the first study to integrate gold-standard PSG, continuous home sleep monitoring, and patient-reported outcomes to assess treatment effects on WASO in postmenopausal women with VMS and sleep disturbances. In this post hoc analysis, greater numerical reductions in WASO were seen in the elinzanetant arm compared with placebo across all measurements. These results align with improvements in sleep disturbances observed in previous OASIS trials using patient-reported outcomes, though the exploratory nature and sample size of this analysis highlight the need for larger confirmatory studies."

Clinical • P2 data • Retrospective data • CNS Disorders • Sleep Disorder • B3GAT1

Effect of elinzanetant on sleep continuity and sleep architecture in postmenopausal women with sleep disturbances: post hoc analysis of the Phase II pilot study NIRVANA (WSS 2025) - "In this post hoc analysis, elinzanetant demonstrated a greater numerical advantage in objective measures of sleep continuity and selected sleep architecture parameters in postmenopausal women with VMS compared with placebo. Notably, elinzanetant reduced awakenings and arousals to a greater extent than placebo, complementing findings from the pivotal OASIS studies using patient-reported outcomes and supporting its potential for menopause-related sleep disturbances. Elinzanetant also increased non-REM sleep (primarily N2), while decreasing N3 sleep, which should be investigated further."

Clinical • P2 data • Retrospective data • CNS Disorders • Sleep Disorder • B3GAT1

Effect of elinzanetant in reducing polysomnographic wakefulness after sleep onset in postmenopausal women: Results from the Phase II NIRVANA exploratory study (WSS 2025) - "A relative reduction in WASO was seen for elinzanetant compared with placebo, which was more pronounced at week 4 than week 12. The magnitude of improvement, while modest, is relevant given the prevalence of sleep disturbances and the lack of therapies with efficacy confirmed by PSG in postmenopausal women. In line with the PROs from the pivotal OASIS trials, these findings support the effect of elinzanetant for menopause-related sleep disturbances."

Clinical • P2 data • CNS Disorders • Sleep Disorder

Advent of NK3R Antagonists for the Treatment of Menopausal Hot Flushes: A Narrative Review. (PubMed, BJOG) - "Fezolinetant has received approval from drug regulatory authorities worldwide, with data from multiple clinical trials showing a marked 60%-80% reduction in the frequency and severity of daily moderate-severe VMS, including in those considered unsuitable for MHT. Very recently, elinzanetant has been approved by the MHRA in the UK for the treatment of VMS in menopause, though it has not yet been approved by the FDA in the US...Data from clinical trials identifying NK3R antagonists as novel therapeutic agents for menopausal VMS are reviewed. Finally, the current status of NK3R antagonists and future directions of study in this area are discussed."

Journal • Review

US FDA extends review of Bayer’s menopause relief drug (WSAU) - "The non-hormonal treatment, elinzanetant, is being reviewed for relieving moderate to severe vasomotor symptoms, also known as hot flashes, associated with menopause. The FDA has extended the review by up to 90 days and did not raise any concern regarding the general approvability of the drug, Bayer said. The drug, branded as Lynkuet, is approved in...Canada."

Canada approval • FDA event • Women's Health

Novel Pharmacotherapies for Menopausal Symptoms. (PubMed, Obstet Gynecol) - "Novel pharmacologic treatments for VMS have emerged in recent decades, some of which are already approved by the U.S. Food and Drug Administration (FDA) (eg, fezolinetant, a neurokinin 3B antagonist), and others are poised to seek FDA approval (eg, elinzanetant, a dual neurokinin 1B and 3B antagonist, and estetrol, a natural estradiol derivative that is unique to the pregnant state). Oxybutynin was shown to be effective for VMS and could provide additional benefits against overactive bladder, but long-term safety data are needed before wider utilization can be recommended."

Journal • CNS Disorders • Epilepsy • Overactive Bladder

Nonhormonal treatments for vasomotor symptoms. (PubMed, Curr Opin Obstet Gynecol) - "Women who cannot use or wish to avoid hormones have a number of nonhormonal options to choose from to treat hot flashes. New science elucidating the biology of hot flashes holds great promise for highly effective treatments that do not have off-target effects."

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