Veozah (fezolinetant) / Astellas - LARVOL DELTA

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

FLASH-CV:: Finding Links Between Hot flASHes and CardioVascular Disease (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P2 trial • Cardiovascular

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

Development of a Highly Potent Neurokinin‑3 Receptor Inhibitor: Design, Synthesis, and Evaluation. (PubMed, ACS Med Chem Lett) - "Despite this potential, only one NK3R ligand (ESN-364) has been clinically approved to date...Notably, 22i exhibited an enhanced membrane permeability and high oral bioavailability. In vivo efficacy studies revealed that oral 22i effectively suppressed luteinizing hormone levels, supporting its potential for further optimization."

Journal

Pharmacokinetics and Safety of Fezolinetant in Women with Hepatic or Renal Impairment. (PubMed, J Clin Pharmacol) - "In conclusion, hepatic impairment affects the metabolism of fezolinetant as shown by progressive increases in systemic exposure. Marginal impacts were noted in women with renal impairment."

Journal • PK/PD data • Hepatology • Renal Disease

Targeting vasomotor symptoms with the new drug fezolinetant - an expert overview. (PubMed, Gynecol Endocrinol) - "Fezolinetant is a precision drug as it targets the pathological mechanism of VMS showing some effect also on sleep disturbances. Given how variable the experience of menopause is, it is important to offer individualized treatment options to women who suffer from menopause-related symptoms and let them be part of the shared decision making."

Journal • Review • CNS Disorders • Sleep Disorder

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

Fezolinetant for vasomotor symptoms in postmenopausal women. (PubMed, Proc (Bayl Univ Med Cent)) - No abstract available

Journal

Efficacy and safety of fezolinetant for vasomotor symptoms in postmenopausal women: a comprehensive systematic review and meta-analysis of randomized controlled trials. (PubMed, Proc (Bayl Univ Med Cent)) - "Given fezolinetant's potential for liver enzyme elevations, it is essential to monitor liver function at baseline and regularly thereafter (monthly for the first 3 months and at 6 and 9 months) to ensure patient safety. Further studies with larger sample sizes are needed to confirm these findings."

Journal • Retrospective data

Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: University of Vermont | Initiation date: May 2025 ➔ Aug 2025

Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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

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