drug
fezolinetant
Marketedupdated 5mo agoby Astellas Pharma US Inc
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying fezolinetant
- phase1A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
- phase2FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
- phase3A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
- phase3A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
- phase2A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause
- phase2Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
- —A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause
- —A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Patent cliff
source: FDA Orange Bookfirst barrier falls
May 12, 2028
~1.6 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (4)
- Mar 28, 2034method-of-use (U-3622)US 10836768
- Mar 28, 2034compositionUS 9422299
- Mar 28, 2034method-of-use (U-3622)US 9987274
- Apr 4, 2031compositionUS 88717614.5y
FDA exclusivities (1)
- May 12, 2028NCENew Chemical Entity (5y)1.6y
News(3)
- Will a ‘reset’ reignite investment in women’s health startups?After peaking in 2024, venture investments in startups involved in the space declined last year. But a broader adoption of AI and a widening definition of what constitutes women’s health could spur…biopharma_dive · 1mo ago
- AbCellera’s menopause medicine ‘sets new efficacy bar’ for hot flashesAbCellera Biologics’ reduction in hot flashes sets it apart from currently commercial oral drugs, including Astellas’ Veozah and Bayer’s Lynkuet, according to BMO Capital Markets.biospace · 1mo ago
- AbCellera women’s health data top ‘most aggressive upside scenario,’ putting Astellas and Bayer on noticeAbCellera has reported phase 2 results “beyond even the most aggressive upside scenario” that its CEO dared to consider, boosting the biotech’s chances of challenging Astellas and Bayer for a women…fiercebiotech · 1mo ago
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