OASIS 3 Trial Supports Efficacy, Long-Term Safety of Elinzanetant for VMS With Menopause

Topline data were announced from the OASIS 3 study evaluating the efficacy and long-term safety of elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause.

Elinzanetant is an investigational dual neurokinin-1,3 (NK-1,3) receptor antagonist designed to modulate the KNDy neurons, a group of estrogen sensitive neurons in the hypothalamus region of the brain. The KNDy neurons become hypertrophic due to decreases in estrogen. This leads to hyperactivation of the thermoregulatory pathway that results in vasomotor symptoms.

The phase 3, double-blind, randomized, placebo-controlled OASIS 3 study (ClinicalTrials.gov Identifier: NCT05030584) included 628 postmenopausal women aged 40 to 65 years. Study participants were randomly assigned to receive elinzanetant 120mg or placebo once daily for 52 weeks.

Results showed treatment with elinzanetant statistically significantly reduced the frequency of moderate to severe vasomotor symptoms from baseline to week 12 compared with placebo (primary endpoint; assessed by hot flash daily diary). The study also confirmed the long-term safety profile of elinzanetant, which was found to be consistent with previous data.

“It is critical that we continue to broaden therapeutic options that will effectively meet the significant needs of menopausal women,” said Nick Panay, Principal Investigator for OASIS 3, Consultant Gynecologist, Imperial College Healthcare NHS Trust, Professor of Practice, Imperial College London and President of International Menopause Society. “These results, coupled with the recent announcement of topline data for OASIS 1 and OASIS 2, strengthen our confidence in the proposed efficacy and safety of elinzanetant as a potential novel nonhormonal solution for women experiencing menopause-related symptoms.”

Additional data from OASIS 3 will be presented at an upcoming medical conference.