NDAORALTABLETPriority Review
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
22
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 2d ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VEOZAH (fezolinetant) is an oral small-molecule neurokinin 3 receptor antagonist approved in May 2023 for the treatment of vasomotor symptoms associated with menopause. It represents a novel mechanism of action targeting the NK3 pathway involved in thermoregulation. The drug addresses a significant unmet need in menopausal symptom management.
$4MPart D
PeakGrowing
7.8 years to LOEEarly peak sales trajectory with rapid uptake in a large addressable market signals strong commercial team investment and expansion opportunities across sales, marketing, and medical affairs functions.
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 (22)
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)
A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice
Started Oct 2025
238 enrolled
Hot Flashes
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause
Started Mar 2025
150 enrolled
Hot Flashes
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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.