Clinical trials

Fezolinetant has shown positive results in a Phase IIa trial in the treatment of menopausal hot flashes and is being evaluated in two further Phase IIa studies

In the menopausal hot flashes study, Fezolinetant treatment achieved the primary endpoints of the trial, namely a significant reduction in:

  • the frequency of moderate-to-severe HF at week-4 (88% reduction from baseline for fezolinetant treated group vs. 38% for placebo, p<0.001) and at week-12 (93% reduction from baseline for fezolinetant treated group vs. 54% for placebo, p<0.001), and
  • the HF severity at week-4 (60% reduction from baseline for fezolinetant treated group vs. 12% for placebo, p<0.001) and at week-12 (70% reduction from baseline for fezolinetant treated group vs.23% for placebo, p<0.001).

Fezolinetant also demonstrated a very rapid onset of action.

A similar Phase IIa proof-of-concept study is ongoing in PCOS and a further Phase IIa trial in Uterine Fibroids in progress.

Ogeda has received regulatory approval for fezolinetant clinical testing in the U.S. Ogeda intends to launch clinical trials of fezolinetant in multiple indications in both the U.S. and Europe in 2017.

The efficacy and safety of fezolinetant in completed Phase I clinical studies in men and women is reported in Fraser et al in J Clin Endocrinol Metab, February 2016, 101(2):417-426.