Elinzanetant

Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant

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화요일, 3월 19, 2024
Health, Fitness & Nutrition, Clinical Trials, Research, Pharmaceutical, Science, International Menopause Society, VMS, Menopause, OASIS, Executive Committee, Imperial College London, Woman, Hot, Safety, Elinzanetant, Phase, Marketing, Pharmaceutical industry

Bayer today announced positive topline results of the Phase III study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.

Key Points: 
  • Bayer today announced positive topline results of the Phase III study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo.
  • The long-term safety profile observed over 52 weeks in the OASIS 3 study is overall consistent with previously conducted studies and published data1,2 on elinzanetant.
  • “OASIS 3 was designed to address the important question of the long-term profile of elinzanetant.
  • “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 non-hormonal solution for women experiencing menopause-related symptoms.”
    OASIS 3 (NCT05030584) is the third Phase III study in the OASIS clinical development program with positive topline results.

Bayer’s elinzanetant meets all primary and key secondary endpoints in pivotal OASIS 1 and 2 Phase III studies

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월요일, 1월 8, 2024
Science, Women, Biotechnology, Research, Pharmaceutical, Health, Consumer, Clinical Trials, Quality of life, Woman, VMS, Hot, Nursing, Executive Committee, Menopause, Sleep, Professor, OASIS, Elinzanetant, Safety, Pharmaceutical industry

Bayer today announced positive top-line results of the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo.

Key Points: 
  • Bayer today announced positive top-line results of the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo.
  • The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data1,2 on elinzanetant.
  • The results of the third Phase III study OASIS 3 (NCT05030584) are expected in the coming months.
  • Bayer plans to submit data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations for treatment of moderate to severe VMS associated with menopause.

Bayer Starts Phase III Clinical Development Program OASIS With Investigational Product, Elinzanetant

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화요일, 8월 31, 2021
Research, Women, FDA, Clinical Trials, Other Health, General Health, Pharmaceutical, Consumer, Health, Science, North American Menopause Society, Journal, Phase II, Ageing, Program, Growth, Group, Goal, Longevity, Kandy, Acquisition, Pharmacokinetics, Medical Affairs Bureau, Phase, Science, Menopause, European Menopause and Andropause Society, Research, Hypothalamus, Therapy, Neuron, NAMS, Flash, Trust, Safety, Patient, Sustainable Development Goals, Brain, Woman, United Nations, Attention deficit hyperactivity disorder predominantly inattentive, OASIS, Health, Pharmaceutical industry, Birth control, Menopause, Elinzanetant, Women’s Healthcare at Bayer, Bayer, MENOPAUSE, ELINZANETANT, WOMEN’S HEALTHCARE AT BAYER, BAYER

Bayer, a global leader in womens healthcare, announced today that it started the Phase III clinical development program OASIS, which aims to evaluate the efficacy and safety of the investigational compound, elinzanetant for the treatment of vasomotor symptoms during menopause.

Key Points: 
  • Bayer, a global leader in womens healthcare, announced today that it started the Phase III clinical development program OASIS, which aims to evaluate the efficacy and safety of the investigational compound, elinzanetant for the treatment of vasomotor symptoms during menopause.
  • Based on the positive Phase II data, we are very pleased to now start the Phase III program with the investigational compound elinzanetant to help address vasomotor symptoms women experience during menopause.
  • The OASIS Phase III clinical development program is investigating the efficacy and safety of elinzanetant 120mg once daily in menopausal women with vasomotor symptoms.
  • The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1).