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For the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause
1

long term safety hero

Data Over Time

OASIS 3 trial data
2

REVIEW STUDY DESIGN

OASIS 3 was a randomized, double-blind, placebo-controlled, multicenter Phase 3 long-term safety trial up to 52 weeks, in postmenopausal women aged 40–65 years with moderate to severe VMS (no baseline requirements for a minimum number of moderate to severe VMS events per week).
2


Primary endpoint:
Mean change in the frequency of moderate to severe VMS, including day and night hot flashes, from baseline to Week 122

 

Graph showing mean change in frequency of moderate to severe VMS from baseline in OASIS 3

Disclaimers:

  • Changes over time, excluding Week 12, were based on descriptive analysis only. No statistical hypotheses were defined, nor was the study powered to detect between-group differences.
  • A clinically meaningful reduction threshold of ≥2 hot flashes over 24 hours compared to placebo was not met.4
SEE SAFETY DATA
Frequency & Severity
PROMIS SD SF 8b Data
    References
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    • 1
      LYNKUET (elinzanetant) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; August 2026.
    • 2
      Panay N, Joffe H, Maki PM, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: a phase 3 randomized clinical trial.
      JAMA Intern Med
      . Published online September 8, 2025. doi:10.1001/jamainternmed.2025.4421
    • 3
      Panay N, Joffe H, Maki PM, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: a phase 3 randomized clinical trial.
      JAMA Intern Med
      . Published online September 8, 2025. (Supplemental Online Content). doi:10.1001/jamainternmed.2025.4421
    • 4
      Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials.
      JAMA
      . 2024;332(16):1343-1354. 
      doi:10.1001/jama.2024.14618