NDAORALTABLETPriority Review
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
24
Data completeness
6/8 — Strong
Priority Review
VEOZAH (fezolinetant) by Astellas is neurokinin 3 receptor antagonists [moa]. Approved for neurokinin 3 receptor antagonist [epc]. First approved in 2023.
Drug data last refreshed 23h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VEOZAH (fezolinetant) is an oral small-molecule neurokinin 3 receptor antagonist approved by the FDA in May 2023 for the treatment of vasomotor symptoms associated with menopause. It represents a novel mechanism of action targeting the neural pathways responsible for hot flashes and night sweats. This first-in-class NK3 antagonist offers a non-hormonal treatment option for menopausal women seeking symptom relief.
$0.004BPart D
Peak7.4 years to LOEEarly commercial trajectory with modest Medicare claims volume; brand team likely focused on market penetration and physician/patient education as awareness grows.
Mechanism of Action
Neurokinin 3 Receptor Antagonists
Pharmacologic Class:
Neurokinin 3 Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (24)
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Started Oct 2026
100 enrolled
Hot Flashes
A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
Started Sep 2026
56 enrolled
Prostate Cancer
Fezolinetant and Vascular Health and Brain Health
Started Sep 2026
220 enrolled
Menopause Hot Flashes
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
Started Jan 2026
60 enrolled
Prostate CancerProstate Cancer (Adenocarcinoma)Prostate Cancer Metastatic Disease+16 more
FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Started Dec 2025
92 enrolled
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.