The therapy’s Prescription Drug User Fee Act date has been set for July 26, 2025.
The FDA has accepted Bayer’s New Drug Application (NDA) for elinzanetant, an investigational non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) associated with menopause, the company announced in a release.1 The therapy is the first dual neurokinin-1 and 3 receptor antagonist in late-stage clinical development and is administered orally once daily.
Bayer's headquarters / Bruno Coelho - stock.adobe.com
“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the US,” said Christine Roth, executive vice president, global product strategy and commercialization, and member of the pharmaceutical leadership team at Bayer, in the same release.1 “If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”
About OASIS-1
Trial Name: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-1)
Clinicaltrials.gov Identifier: NCT05042362
Sponsor: Bayer
Summary: In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes.
The NDA application is supported by positive results from the OASIS 1, 2 and 3 phase three studies evaluating the efficacy and safety of elinzanetant versus placebo. Findings from OASIS 1 (NCT05042362) and 2 (NCT05099159) were published late this summer in JAMA,2 and results of the phase three OASIS 3 (NCT05030584) study supporting efficacy and additional long-term safety data were presented at The Menopause Society annual meeting in September 2024.
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OASIS 1 and 2 were randomized, double-blind, phase 3 clinical trials conducted among postmenopausal women aged 40 to 65 experiencing moderate to severe VMS. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks.
The primary endpoint included mean change in frequency and severity of moderate-to-severe VMS from baseline to weeks 4 and 12, measured by an electronic hot flash daily diary. Secondary endpoints included sleep quality and overall quality of life related to menopause.
A total of 309 and 324 participants across 184 sites in 15 countries completed OASIS 1 and 2, respectively. Although frequency and severity of VMS were comparable between the groups at baseline, elinzanetant reduced VMS frequency at weeks 4 and week 12. Elinzanetant also improved VMS severity at week 4 and week 12. Additionally, elinzanetant improved sleep disturbances and menopause-related quality of life at week 12 and its safety profile was favorable.
About OASIS-2
Trial Name: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)
Clinicaltrials.gov Identifier: NCT05099159
Sponsor: Bayer
Summary: In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes.
OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of VMS over 52 weeks. It enrolled and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. Consistent with findings from OASIS 1 and OASIS 2, OASIS 3 showed that elinzanetant effectively reduced the frequency of moderate-to-severe VMS from baseline to week 12 compared to placebo.3
“The detailed results of OASIS 3 are complementing the positive results of OASIS 1 and 2, addressing the question on its long-term profile and indicating the potential of elinzanetant to treat moderate to severe VMS associated with menopause,” said Christian Rommel, global head of research and development at Bayer AG’s Pharmaceuticals Division, in a separate news release.3 “We look forward to continuing our discussions with health authorities around the world regarding marketing authorizations for this compound.”
The OASIS 4 study is an expansion of the clinical phase 3 program and aims to investigate the efficacy and safety of elinzanetant in women with moderate-to-severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.4
Beyond the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory phase 2 randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography.1
Up to 80% of women experience VMS at some point during menopause, and by 2030, the global population of women in menopause is expected to reach 1.2 billion, with 47 million women entering this phase annually.1
But despite the impact of menopausal symptoms on women’s health, “many go without treatment due to gaps in awareness, education, and limitation of treatment options available,” according to Roth.4 Bayer is working to close these gaps with the potential approval of elinzanetant by its Prescription Drug User Fee Act deadline of July 26, 2025.5
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