NDAORALTABLETPriority Review
Approved
May 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
19
Mechanism of Action
Neurokinin 3 Receptor Antagonists
Pharmacologic Class:
Neurokinin 3 Receptor Antagonist
Clinical Trials (5)
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
540 enrolled
Hot Flashes
Loss of Exclusivity
LOE Date
Mar 28, 2034
98 months away
Patent Expiry
Mar 28, 2034
Exclusivity Expiry
May 12, 2028
Company
Astellas
China - Shenyang