Veozah (fezolinetant) / Astellas - LARVOL DELTA

Effect of fezolinetant on sleep, health-related quality of life and work productivity. (PubMed, Climacteric) - "Fezolinetant reduced moderate to severe VMS due to menopause and improved patient-reported sleep outcomes, with benefits maintained over 1 year. Improvements in VMS and sleep were associated with better work productivity."

HEOR • Journal • CNS Disorders • Sleep Disorder

A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: Astellas Pharma Inc

New P3 trial

High-throughput experimentation to explore a novel reaction toward triazolopiperazines (ACS-Fall 2026) - "Despite their clinical relevance, exemplified by Sitagliptin and Fezolinetant, current synthetic routes rely on lengthy, metal-catalysed procedures with limited scope and poor sustainability. Reaction optimization was then driven by a three-stage Design of Experiments (DoE) strategy executed via acoustic droplet ejection (ECHO technology). The optimized conditions were then applied to nanoscale synthesis in 1536-well plates, enabling the rapid exploration o of an extensive chemical spaceand the generation of large, structurally diverse triazolopiperazine libraries."

A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Astellas Pharma Global Development, Inc.

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Real-world safety signals of fezolinetant in women with menopausal vasomotor symptoms: a pharmacovigilance analysis of the WHO VigiAccess database. (PubMed, Menopause) - "This exploratory analysis found that fezolinetant's real-world safety profile was broadly consistent with phase 3 trials, with efficacy in reducing menopausal vasomotor symptoms. Disproportionality signals mainly involved liver and neurological events. These findings do not reflect absolute risk or incidence and should be considered hypothesis-generating. In view of its established benefit, they support a balanced benefit-risk assessment for clinical use."

Adverse events • Journal • Real-world evidence • CNS Disorders • Insomnia • Migraine • Pain • Psychiatry • Sleep Disorder

GRACE: A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause (clinicaltrials.gov) - P=N/A | N=105 | Completed | Sponsor: Astellas Pharma Europe Ltd. | Active, not recruiting ➔ Completed

Trial completion

Real-world safety profile of fezolinetant: a disproportionality analysis based on the FAERS database. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The early onset window (first 100 days) suggests that closer liver function monitoring may be considered during treatment initiation. These findings provide real-world evidence to complement clinical trial data and may inform clinical safety assessment and risk management."

Journal • Real-world evidence • Hepatology • Liver Failure

Treatment of Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy. (PubMed, Prostate) - "Hormonal agents such as cyproterone acetate and estrogen appear to be the most effective treatments, although they are associated with side effects. Non-pharmacological options like acupuncture and CBT may offer some benefit, while dietary supplements seem to be ineffective. Future studies are needed also to evaluate newer treatments, such as fezolinetant, in this patient population."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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

TACR3 variant confers resilience to aging and Alzheimer's disease. (PubMed, medRxiv) - "rs2765 WT confers resilience to age- and AD-related cognitive decline through RBMX-dependent regulation of NK3-R expression, with effects of remarkable size cascading from memory to systemic aging. rs2765 genotyping could stratify individuals for NK3-R modulator therapy (e.g., fezolinetant or senktides) and identify those maintaining function despite pathological burden, complementing APOE-based risk assessment in precision geromedicine."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • APOE

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

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

Central Nervous System Safety of Fezolinetant from Pooled Analysis of 52-Week, Phase 3 Studies (SKYLIGHT 1, 2, and 4) (ENDO 2026) - P3 | "There is no evidence to support risk for depression, somnolence, memory loss, or abuse liability with fezolinetant. This analysis supports the CNS safety of fezolinetant for treatment of moderate to severe VMS."

P3 data • Retrospective data • CNS Disorders • Depression • Suicidal Ideation

OPTION‑VMS: Preliminary Analysis of A Phase 4 Observational, Real‑World Study of Non‑Hormonal Pharmacotherapies for Bothersome Menopause‑Associated Vasomotor Symptoms and Depression and Anxiety (ENDO 2026) - P | "Methods OPTION-VMS (NCT06049797) is an ongoing, phase 4, longitudinal, multicenter, observational study of women aged 40-75 years with bothersome menopausal VMS initially prescribed non-HT (fezolinetant, SSRIs/SNRIs, and other non-HTs [eg, gabapentin, oxybutynin]). Conclusions Preliminary analysis of OPTION VMS showed improvements in VMS bother and depression/anxiety symptoms with non-HT use, including fezolinetant. Results align with randomized controlled trial data of fezolinetant, highlighting real-world benefits beyond VMS relief, including improvements in depression/anxiety symptoms."

Clinical • P4 data • Real-world • Real-world evidence • CNS Disorders • Depression • Mood Disorders • Psychiatry • Sleep Disorder

Neurokinin-3 Receptor Antagonism and Headache Adverse Events Signals: A FAERS Disproportionality Analysis of Fezolinetant Versus Non-Hormonal Therapies for Menopausal Vasomotor Symptoms (ENDO 2026) - "Fezolinetant was compared with non-hormonal therapies for vasomotor symptoms: paroxetine, citalopram, oxybutynin, and gabapentin. This is the first FAERS disproportionality analysis of fezolinetant-associated headache subtypes relative to non-hormonal therapies. Fezolinetant shows higher reporting odds across all subtypes, particularly for head discomfort. Findings are hypothesis-generating, may reflect reporting bias, and residual confounding cannot be excluded."

Adverse events • Late-breaking abstract • CNS Disorders • Migraine • Pain

Central Nervous System Safety of Fezolinetant from Pooled Analysis of 52-Week, Phase 3 Studies (SKYLIGHT 1, 2, and 4) (ENDO 2026) - P3 | "There is no evidence to support risk for depression, somnolence, memory loss, or abuse liability with fezolinetant. This analysis supports the CNS safety of fezolinetant for treatment of moderate to severe VMS."

P3 data • Retrospective data • CNS Disorders • Depression • Suicidal Ideation

Fezolinetant for the management of vasomotor symptoms in patients with breast cancer. (ASCO 2026) - "In this real-world observational cohort of patients receiving endocrine therapy, hot flashes were common, severe, and frequently refractory to prior interventions. Initiation of fezolinetant was associated with rapid, clinically meaningful improvement in hot flash frequency and severity, with high tolerability and treatment continuation. These findings support the feasibility and potential benefit of fezolinetant for the management of endocrine therapy–associated vasomotor symptoms in patients with breast cancer and warrant prospective investigation."

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

HIGHLIGHT 1: A randomized, placebo-controlled, double-blind, phase 3 clinical study to investigate the efficacy and safety of fezolinetant for treatment of moderate to severe vasomotor symptoms (hot flashes) in women with stage 0 to 3 hormone receptor–positive breast cancer who are receiving adjuvant endocrine therapy. (ASCO 2026) - P3 | "Adjuvant endocrine therapy, e.g., tamoxifen and aromatase inhibitors, can lead to premature menopause and vasomotor symptoms (VMS). Treatment-emergent adverse events (TEAEs) assess fezolinetant safety and tolerability. The DMC last reviewed the study in November 2025 and suggested that the study continue as planned."

Clinical • P3 data • Basal Cell Carcinoma • Breast Cancer • CNS Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Non-melanoma Skin Cancer • Oncology • Sleep Disorder • Solid Tumor • Women's Health

OPTION-VMS: A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats (clinicaltrials.gov) - P=N/A | N=999 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Active, not recruiting ➔ Completed

Real-world evidence • Trial completion

Hepatic Adverse Event Signals of Fezolinetant in Real-World Use Based on Postmarketing Surveillance. (PubMed, Obstet Gynecol) - "Data identify a signal of hepatic adverse event reporting for fezolinetant, primarily characterized by transaminase elevations rather than clinically overt liver injury. The early failure pattern suggests that hepatic events may tend to occur relatively early after treatment initiation, which highlights the importance of baseline assessment and early-phase monitoring, but continued clinical vigilance remains warranted."

Adverse events • Journal • P4 data • Real-world evidence • Hepatology • Liver Failure

FAVES-B: Fezolinetant and Vascular Health and Brain Health (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: Rebecca Thurston

New P3 trial

CANDLELIGHT: A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice (clinicaltrials.gov) - P=N/A | N=238 | Recruiting | Sponsor: Astellas Pharma Europe Ltd.

New trial • Real-world evidence

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