Lynkuet (elinzanetant) / Bayer - LARVOL DELTA

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."

Journal

Hopes and cautions with neurokinin antagonists for the management of vasomotor symptoms. (PubMed, Maturitas) - No abstract available

Journal

The Impact Of Elinzanetant Treatment On Bone Health And Body Composition In Postmenopausal Women (ENDO 2025) - "These data expand on EZN safety profile and further point to novel potential benefits for the skeleton and body composition of postmenopausal women. Further research is warranted to provide conclusive evidence of the benefits of EZN specifically in post-menopausal women with obesity/overweight status or osteoporosis. Sponsorship: Bayer U.S., Whippany, NJ, USA"

Clinical • Late-breaking abstract • Genetic Disorders • Musculoskeletal Diseases • Obesity • Osteoporosis • Rheumatology

Efficacy and safety of elinzanetant for vasomotor symptoms associated with adjuvant endocrine therapy: Phase 3 OASIS 4 trial. (BASCO-MN 2025) - No abstract available

Clinical • P3 data • Breast Cancer • Oncology • Solid Tumor

Exit Interviews Examining Changes to Mood and Work/Productivity Impacts Related to Vasomotor Symptoms: Perspectives of Postmenopausal Women Receiving Elinzanetant in Phase III Clinical Trials. (PubMed, Patient) - "This study provides novel insights into women's experiences of VMS-associated impacts on mood and work/productivity, highlighting the emotional and economic burdens of VMS. Data support and contextualize the treatment benefits of elinzanetant on mood and work/productivity that are meaningful to women."

Interview • Journal • P3 data • Women's Health

MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause (GOV.UK) - "The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause."

MHRA approval • Women's Health

Pharmacological Treatments for Menopausal Vasomotor Symptoms: A Systematic Review and Bayesian Network Meta-Analysis of Efficacy and Safety. (PubMed, Eur J Obstet Gynecol Reprod Biol) - "Conjugated estrogens and drospirenone with estradiol are the most effective options for reducing VMS frequency and severity, and Fezolinetant and Elinzanetant showed moderate efficacy, with overall similar safety across treatments."

Journal • Retrospective data • Review

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=473 | Active, not recruiting | Sponsor: Bayer | Trial completion date: Dec 2026 ➔ Jun 2027

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

The Effects of Elinzanetant on Simulated Driving Performance in Healthy Women: A Randomized Phase I Study. (PubMed, Clin Transl Sci) - P1 | "Our study demonstrated no clinically relevant next-morning residual effects following bedtime elinzanetant dosing and confirmed the elinzanetant benefit: risk balance was not adversely impacted by somnolence or fatigue the following morning. Trial Registration: ClinicalTrials.gov identifier: NCT06219902."

Clinical • Journal • P1 data • Fatigue

Impact of elinzanetant on sleep disturbances and quality of life in women undergoing adjuvant endocrine therapy for breast cancer: Phase 3 OASIS 4 trial. (ASCO 2025) - P3 | "Women aged 18–70 years being treated for, or at high risk of developing, HR+ breast cancer and experiencing ≥35 moderate-to-severe VMS/week associated with tamoxifen/aromatase inhibitors were randomized 2:1 to receive EZN 120 mg for 52 weeks or placebo for 12 weeks followed by EZN for 40 weeks. EZN demonstrated efficacy in reducing sleep disturbance and improving quality of life in women undergoing AET for breast cancer. Concomitant intake of EZN and AET may improve tolerability and adherence to AET, with a potentially favorable impact on breast cancer outcomes."

Clinical • HEOR • P3 data • Breast Cancer • CNS Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Sleep Disorder • 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

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

Elinzanetant significantly reduces frequency of moderate to severe vasomotor symptoms associated with endocrine therapy for breast cancer in Phase III OASIS-4 study (Bayer Press Release) - P3 | N=473 | OASIS-4 (NCT05587296) | Sponsor: Bayer | "In OASIS-4, elinzanetant showed statistically significant mean reductions in frequency of VMS compared to placebo from baseline at week 4 with −6.5 (95% confidence interval [CI], −7.2 to −5.8) with elinzanetant and −3.0 (95% CI, −3.9 to −2.2) with placebo, with statistical significance between elinzanetant and placebo (least squares [LS] mean difference [95% CI]: −3.5 [−4.4, −2.6]; p<0.001). At week 12, reductions in VMS frequency were −7.8 (95% CI, −8.5 to −7.1) with elinzanetant and −4.2 (95% CI, −5.2 to −3.2) with placebo, with statistical significance between elinzanetant and placebo (LS mean difference [95% CI]: −3.4 [−4.2, −2.5]; p<0.001)."

P3 data • Hormone Receptor Positive Breast Cancer

Efficacy and safety of elinzanetant in vasomotor symptoms associated with menopause: a meta-analysis of randomized controlled trials (ACOG 2025) - "This meta-analysis included three RCTs reporting data on 995 patients (551 elinzanetant versus 444 placebo). Mean age ranged from 54.4 to 55.6 years. The combined analysis showed that elinzanetant reduced the frequency (MD −3.09; 95% CI, −4.18 to −2.01; I2=0%) and intensity (MD −0.32; 95% CI, −0.45 to −0.21; I2=39%) of VMS."

Retrospective data • CNS Disorders • Sleep Disorder • B3GAT1

Comment on "Efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis". (PubMed, Maturitas) - No abstract available

Journal • Retrospective data

Psychometric evaluation of the HFDD, PROMIS SD SF 8b, and MENQOL questionnaire in women experiencing vasomotor symptoms associated with menopause. (PubMed, J Patient Rep Outcomes) - "Findings provide evidence that HFDD, PROMIS SD SF 8b, and MENQOL scores are valid, reliable and responsive to change, supporting their use for assessing key efficacy endpoints in VMS clinical trials."

Clinical • Journal • CNS Disorders • Sleep Disorder

Novel nonhormonal treatments for vasomotor symptoms of menopause. (PubMed, Curr Opin Obstet Gynecol) - "Targeting of the NK receptor in the hypothalamus has led to the availability of nonhormonal options for menopausal women suffering from hot flashes."

Journal

A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. (PubMed, J Clin Med) - "In 2023, the FDA approved fezolinetant, the first selective NK3R antagonist, for the treatment of moderate to severe VMS associated with menopause. In this regard, elinzanetant represents a promising non-hormonal treatment that targets the underlying causes of VMS through NK-1 and NK-3 receptor pathways. The development of neurokinin B antagonist for VMS treatment exemplifies the impact of advanced pharmacological research on gynecological endocrinology."

Journal • Review • CNS Disorders • Endocrine Disorders • Sleep Disorder

Efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis. (PubMed, Maturitas) - "Fezolinetant and elinzanetant are effective options for managing vasomotor symptoms. However, further research is needed to compare these treatments directly and evaluate their long-term safety profiles across different patient populations."

Journal • Retrospective data • Review