Drugs in Dev. Obstetrics/Gynecology (Women’s Health)
Phase III
Japan 
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Astellas Provides Update on Fezolinetant New Drug Application in U.S.
Details : ESN364 (fezolinetant) works by blocking NKB binding on the kisspeptin/neurokinin B/dynorphin neuron to modulate neuronal activity in the hypothalamus to reduce the frequency and severity of moderate to severe VMS due to menopause.
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 20, 2023
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fezolinetant is an investigational selective NK3 receptor antagonist and is not approved for use anywhere in the world. Safety analyses demonstrated that both endometrial hyperplasia and endometrial malignancy were within pre-specified limits for fezolin...
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 10, 2022
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Medicines Agency Accepts Astellas' Marketing Authorization Application for Fezolinetant
Details : Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of ESN364 (fezolinetant) for the treatment of moderate to severe VMS associated with menopause.
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 30, 2022
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
Details : ESN364 (fezolinetant), an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms o...
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 18, 2022
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The primary endpoint for ESN364 (fezolinetant), an investigational selective neurokinin-3 receptor, antagonist assessing endometrial health was achieved and the most common treatment-emergent adverse events were headache and COVID-19, consistent with pla...
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 03, 2022
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Astellas Submits Fezolinetant New Drug Application to U.S. FDA
Details : Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 24, 2022
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Findings showed the SKYLIGHT 1 trial of ESN364 (fezolinetant) administered once daily met all four co-primary endpoints, demonstrating a statistically significant reduction from baseline in frequency and severity of moderate to severe VMS at weeks 4 and ...
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 05, 2022
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ESN364 (fezolinetant) is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause.
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 09, 2022
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Based on 12-week data analysis in 302 participants, fezolinetant did not meet pre-defined endpoints for efficacy and, improvements from baseline were observed in the fezolinetant 30 mg treatment group, the results did not meet statistical significance.
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 15, 2022
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The SKYLIGHT 1 and SKYLIGHT 2 pivotal Phase III trials reached all co-primary endpoints, showing a significant reduction in the incidence and severity of mild to extreme VMS from baseline to week 4 and week 12 for women taking fezolinetant 30 and 45 mg o...
Product Name : ESN364
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 19, 2021
Lead Product(s) : Fezolinetant
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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