Bayer's elinzanetant, a non-hormonal therapy, has demonstrated significant efficacy in reducing the frequency and severity of moderate to severe vasomotor symptoms (hot flashes) in post-menopausal women. The positive results come from two pivotal Phase III trials, OASIS 1 and 2, marking a potential advancement in menopause symptom management.
The OASIS 1 (NCT05042362) and OASIS 2 (NCT05099159) trials enrolled 396 and 400 postmenopausal women, respectively, aged 40-65 years. The trials compared elinzanetant to placebo, with the primary endpoints being the reduction in frequency and severity of hot flashes at four and twelve weeks from baseline. Elinzanetant met all four primary endpoints, showing statistically significant improvements compared to placebo.
Efficacy Data from OASIS Trials
In the OASIS 1 trial, participants receiving elinzanetant experienced a mean reduction of -3.29 and -3.22 in hot flash frequency at four and twelve weeks, respectively, compared to placebo. The severity of hot flashes also decreased, with a mean reduction of -0.33 and -0.40 at four and twelve weeks, respectively.
Similarly, the OASIS 2 trial showed a mean reduction in hot flash frequency of -3.04 and -3.24 at four and twelve weeks, respectively, with elinzanetant treatment compared to placebo. The severity of hot flashes was reduced by -0.22 and -0.29 at four and twelve weeks, respectively.
Beyond the primary endpoints, the trials also met three secondary endpoints, demonstrating improvements in sleep disturbances, menopause-related quality of life, and a reduction in hot flash frequency after one week compared to baseline. The most common treatment-related side effects were headache and fatigue.
Competitive Landscape
Elinzanetant is a dual neurokinin-1 and 3 (NK-1,3) receptor antagonist. These receptors play a role in regulating the hypothalamus-pituitary-adrenal (HPA) axis, which is responsible for hormone regulation. A key competitor is Astellas' Veozah (fezolinetant), a NK-3 receptor agonist approved by the FDA for hot flashes in May 2023. Veozah generated Y7.3 billion ($46.8 million) in sales last year. According to GlobalData analysis, Veozah and elinzanetant are forecasted to respectively earn $1.8 billion and $1 billion in sales in 2030.
Future Plans
Bayer is also evaluating elinzanetant for sleep disturbances associated with menopause in a Phase II NIRVANA trial (NCT06112756). The company plans to file for regulatory approval for elinzanetant based on the positive data from the three OASIS trials. JoAnn Pinkerton, professor and director of Midlife Health at UVA Health, stated, "These results are exciting news for women who suffer from moderate to severe hot flashes and build on our confidence that elinzanetant may be a potential non-hormonal solution for them."
