NDAORALTABLETPriority Review
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
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 22h ago · AI intelligence enriched 2w 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 treating moderate-to-severe vasomotor symptoms associated with menopause. It represents a novel mechanism targeting NK3 receptors in the hypothalamus to reduce hot flashes and night sweats. This first-in-class approach addresses a significant unmet need in women's health.
$0.004BPart D
GrowthGrowing
7.9 years to LOEEarly-stage growth product with small current claims volume suggests opportunity for significant team expansion and commercial development roles as awareness and adoption increase.
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 (20)
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 to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause
Started Mar 2025
150 enrolled
Hot Flashes
A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause
Started Oct 2024
105 enrolled
Hot Flashes
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
Started Jul 2024
984 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.