Veozah (fezolinetant) / Astellas - LARVOL DELTA

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=1003 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Real-world evidence

The Efficacy of Fezolinetant for the Treatment of Vasomotor Symptoms due to Menopause in Individuals with and without Diabetes Mellitus: A Pooled Phase 3 Analysis (ENDO 2025) - P3 | "Conclusions Fezolinetant can be regarded as an effective treatment for moderate to severe VMS in individuals with and without diabetes mellitus. Further investigations are warranted in this population."

Clinical • P3 data • Diabetes • Metabolic Disorders

Brain-Selective Estrogen Therapy to Prevent Menopausal Hot Flushes in a Primate Model (ENDO 2025) - "Recently, the FDA approved the neurokinin-3 antagonist fezolinetant for HF treatment, which modulates the activity of the neurokinin-B neurons involved in thermoregulation...Post OVX peripheral E2 levels were low/undetectable and DHED treatment did not result in any increase, indicating DHED treatment yields negligible circulating E2 despite being as effective as oral EE for HF. These findings underscore the effectiveness of DHED as a novel, innovative, and safe therapy of menopausal HFs without unwanted side effects in the periphery."

CNS Disorders • Depression • Mood Disorders • Nephrology • Oncology • Psychiatry • Renal Disease

Response to: Letter to the Editor Regarding: Safety of Fezolinetant for Treatment of Moderate-to-Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. (PubMed, Adv Ther) - No abstract available

Journal • P3 data • Retrospective data • Oncology

Letter to the Editor Regarding: Safety of Fezolinetant for Treatment of Moderate-to-Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. (PubMed, Adv Ther) - No abstract available

Journal • P3 data • Retrospective data • Oncology

The Role of Patient-Reported Outcomes in US FDA Novel Drug Approvals and Reimbursement Decisions (2020-2024) (ISPOR 2025) - "Rinvoq (AbbVie) - PRO data showed improved quality of life in rheumatoid arthritis, contributing to $2.3 billion...Zeposia (Bristol-Myers Squibb) - PROs on fatigue reduction generated $500 million. Imcivree (Rhythm Pharmaceuticals) - PRO data supported FDA approval 2022: FDA : 37 drugs, with 30% (11 drugs) Reimbursement : 85 total approvals, with 35% (30 approvals) Adbry (LEO Pharma) - PROs on itch reduction generated $90 million . Camzyos (Bristol-Myers Squibb) - Symptom relief PROs were key 2023: FDA : 49 drugs, with 33% (16 drugs) Reimbursement 95 total approvals, with 45% (43 approvals. Leqembi (Eisai/Biogen) - FDA approval and Medicare conditional reimbursement for Alzheimer's disease leveraged PROs on cognitive function improvements, generating $200 million/ Jaypirca (Eli Lilly) - Patient-reported symptom relief supported FDA and payer decisions for mantle cell lymphoma... The inclusion of PROs in FDA novel drug approvals increased from 18% in 2020 to 40% in..."

Clinical • Patient reported outcomes • Reimbursement • US reimbursement • Alzheimer's Disease • CNS Disorders • Fatigue • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Mantle Cell Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology

Effect of Fezolinetant on Weight, Waist Circumference, and BMI: Data from Phase 3, Randomized, Double-blind, Placebo-controlled Studies (SKYLIGHT 1, 2 and 4) over 52 Weeks (ACOG 2025) - "Abstract is embargoed at this time."

Clinical • P3 data

A Review of Hot Flash Management in Patients with Prostate Cancer. (PubMed, J Clin Endocrinol Metab) - "Clinicians should be prepared to offer evidence-based management options for the detrimental effects of ADT. Proven therapies for VMS including oxybutynin and antidepressants may soon be complemented by neurokinin antagonists which currently boast great efficacy for menopausal hot flashes. Hormonal options like transdermal oestrogen are most likely to provide relief but gynaecomastia may develop."

Journal • Endocrine Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Evaluation of the Impact of Fezolinetant vs Placebo on Indirect Costs Among Women With VMS Associated With Menopause (ISPOR 2025) - P3 | "Fezolinetant, which alleviates VMS frequency and severity, offers meaningful work productivity benefits and reduced indirect costs for women with moderate to severe VMS, underscoring a potential economic value in managing menopause-related symptoms."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Fatigue • Mood Disorders • Psychiatry • Sleep Disorder

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

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health (clinicaltrials.gov) - P2/3 | N=200 | Not yet recruiting | Sponsor: University of Colorado, Denver

New P2/3 trial • Cardiovascular • Obesity • Women's Health • CXCL8

Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: University of Vermont

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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

Fezo-ADT: Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shehzad Basaria, M.D.

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A profile of safety and efficacy of fezolinetant for the treatment of menopausal vasomotor symptoms. (PubMed, Expert Rev Clin Pharmacol) - "Fezolinetant represents a highly anticipated innovation, offering the possibility to bridge the therapeutic gap for many women who cannot or do not wish to use MHT. While the potential application of fezolinetant in some clinical settings will add substantial value to the management of VMS, some research gaps need to be addressed in order to provide meaningful insight into the benefit-risk profile that ultimately will improve counseling and prescription tailoring in symptomatic menopausal women."

Journal • Review • CNS Disorders • Sleep Disorder

Physiologically Based Pharmacokinetic (PBPK) Model to Predict the Magnitude of Drug-Drug Interaction Between Fezolinetant and CYP1A2 Inhibitors. (PubMed, J Clin Pharmacol) - "Fezolinetant is primarily metabolized by CYP1A2 and was found to be a sensitive substrate for CYP1A2 metabolism based on a clinical DDI study with strong CYP1A2 inhibitor, fluvoxamine...The final verified model was used to predict fezolinetant exposure following coadministration with mexiletine (moderate CYP1A2 inhibitor), ciprofloxacin (moderate CYP1A2 inhibitor), and cimetidine (weak CYP1A2 inhibitor)...Another moderate CYP1A2 inhibitor, ciprofloxacin, was predicted to increase fezolinetant Cmax by 1.39 to 1.49 fold and AUCinf by and 1.99 to 2.33 fold. The results of the PBPK analysis supported global labeling language statements for fezolinetant."

Journal • PK/PD data • Women's Health • CYP1A2

FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy (clinicaltrials.gov) - P2 | N=92 | Not yet recruiting | Sponsor: Yale University

New P2 trial • Breast Cancer • Oncology • Solid Tumor

An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects. (PubMed, Drug Des Devel Ther) - "In total, 3 (18.8%) subjects experienced 4 drug-related treatment-emergent adverse events; all mild in severity. Linear PK was confirmed within the dose range of 15 to 60 mg in healthy Chinese women."

Journal • PK/PD data

In menopause-related moderate-to-severe vasomotor symptoms not suitable for hormone therapy, fezolinetant safely improved symptoms. (PubMed, Ann Intern Med) - "GIM/FP/GP: [Formula: see text]."

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

Starlight 3: A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause (clinicaltrials.gov) - P3 | N=277 | Active, not recruiting | Sponsor: Astellas Pharma Inc | Recruiting ➔ Active, not recruiting

Enrollment closed

Menopause part I: Vasomotor symptoms (I). (PubMed, Taiwan J Obstet Gynecol) - "By contrast, another MONGLIGHT RCTs for East Asia population seemed to controversial therapeutic effect for VMS treatment, but there is no doubt that safety issue is also satisfied, contributing to the need of more RCTs to validate its efficacy in diverse population. The current review will summary the recent advance of this new landscape in the management of women with moderate-to-severe VMS and particularly focus on the fezolinetant product."

Clinical • Journal • Review

Nonhormonal Treatment of Vasomotor Symptoms of Menopause. (PubMed, Cardiol Rev) - "Various nonhormonal options, including lifestyle modifications, acupuncture, cognitive behavioral therapy, and pharmacological agents such as SSRIs/SNRIs, gabapentin, clonidine, and the emerging class of neurokinin-3 receptor antagonists, are examined. Clinical trials demonstrate that SSRIs (eg, paroxetine) and SNRIs (eg, venlafaxine) provide significant VMS relief, particularly for women who are unable to use HRT. Neurokinin-3 receptor antagonists, such as fezolinetant, show promising results in reducing hot flashes without affecting cardiovascular health. While more research is needed to further assess long-term outcomes, nonhormonal therapies present a viable and safer alternative for managing VMS, especially for women at risk for cardiovascular complications."

Journal • Breast Cancer • Cardiovascular • Oncology • Solid Tumor

Fezolinetant effect on vasomotor symptoms due to menopause in women unsuitable for hormone therapy. (PubMed, Curr Med Res Opin) - P3 | "This pooled analysis demonstrated efficacy of fezolinetant vs. placebo in reducing frequency and severity of VMS due to menopause in participants unsuitable for HT. SKYLIGHT 1 - ClinicalTrials.gov, NCT04003155; https://clinicaltrials.gov/ct2/show/NCT04003155 (conducted between July 2019 and August 2021); SKYLIGHT 2 - ClinicalTrials.gov, NCT04003142; https://clinicaltrials.gov/ct2/show/NCT04003142 (conducted between July 2019 and April 2021)."

Journal • CNS Disorders • Sleep Disorder

Management of vasomotor symptoms in cancer patients. (PubMed, Oncologist) - "The evidence for various treatment options, including novel agents such as fezolinetant that target the hypothalamic thermoregulatory pathway, will be evaluated. Finally, special considerations in different patient populations based on cancer types (eg, breast, prostate) and age groups (eg, older adults) will be explored."

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