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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.
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 fezolinetant-treated patients.
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.
ESN364 (fezolinetant) is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause.
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 of menopause.
Fezolinetant is an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
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 12 versus placebo.
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.
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 placebo.
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 once-daily.