Elinzanetant (BAY3427080) Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Elinzanetant (BAY3427080) comprises 4 peer-reviewed publications across 4 journals, 11 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Hot Flashes. Most recent publication: Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials., JAMA, 2025.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials.
    Pinkerton JV, Simon JA, Joffe H, et al. · JAMA · 2025
    PubMed: PMID 39172446 · NCT05042362 (OASIS-1) · Hot Flashes
  2. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial.
    Panay N, Joffe H, Maki PM, et al. · JAMA Intern Med · 2025
    PubMed: PMID 40920404 · NCT05030584 (OASIS-3) · Hot Flashes
  3. The Effects of Elinzanetant on Simulated Driving Performance in Healthy Women: A Randomized Phase I Study.
    Francke K, Klein S, Burke J, et al. · Clin Transl Sci · 2025
    PubMed: PMID 40569207 · NCT06219902 · Hot Flashes
  4. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer.
    Cardoso F, Parke S, Brennan DJ, et al. · N Engl J Med · 2025
    PubMed: PMID 40454634 · NCT05587296 (OASIS-4) · Hot Flashes

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT05030584
OASIS-3
Hot FlashesMean Change in Frequency of Moderate to Severe Hot Flashes (HFs) From Baseline to Week 12 (Assessed by Hot Flash Daily Diary [HFDD])
Baseline to Week 12
Elinzanetant (BAY3427080)6.71 Number of HF (±7.15 Standard Deviation)
Elinzanetant (BAY3427080)-5.40 Number of HF (±7.29 Standard Deviation)
Placebo6.81 Number of HF (±6.15 Standard Deviation)
Placebo-3.50 Number of HF (±4.96 Standard Deviation)
NCT05042362
OASIS-1
Hot FlashesMean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD).
From baseline to Week 12
Elinzanetant 120 mg-8.74 Hot Flashes per day (±6.70 Standard Deviation)
Elinzanetant 120 mg13.38 Hot Flashes per day (±6.57 Standard Deviation)
Placebo - Elinzanetant 120 mg14.26 Hot Flashes per day (±13.94 Standard Deviation)
Placebo - Elinzanetant 120 mg-5.53 Hot Flashes per day (±10.16 Standard Deviation)
NCT05042362
OASIS-1
Hot FlashesMean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]).
From baseline to Week 4
Elinzanetant 120 mg-7.48 Hot Flashes per day (±5.80 Standard Deviation)
Elinzanetant 120 mg13.38 Hot Flashes per day (±6.57 Standard Deviation)
Placebo - Elinzanetant 120 mg14.26 Hot Flashes per day (±13.94 Standard Deviation)
Placebo - Elinzanetant 120 mg-4.37 Hot Flashes per day (±6.73 Standard Deviation)
NCT05042362
OASIS-1
Hot FlashesMean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD).
From baseline to Week 12
Elinzanetant 120 mg-0.95 Units on a scale (±0.78 Standard Deviation)
Elinzanetant 120 mg2.56 Units on a scale (±0.22 Standard Deviation)
Placebo - Elinzanetant 120 mg-0.55 Units on a scale (±0.60 Standard Deviation)
Placebo - Elinzanetant 120 mg2.53 Units on a scale (±0.23 Standard Deviation)
NCT05042362
OASIS-1
Hot FlashesMean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD).
From baseline to Week 4
Elinzanetant 120 mg2.56 Units on a scale (±0.22 Standard Deviation)
Elinzanetant 120 mg-0.73 Units on a scale (±0.64 Standard Deviation)
Placebo - Elinzanetant 120 mg-0.39 Units on a scale (±0.43 Standard Deviation)
Placebo - Elinzanetant 120 mg2.53 Units on a scale (±0.23 Standard Deviation)
NCT05099159Hot FlashesMean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD)
From baseline to Week 12
Elinzanetant 120 mg-9.96 Hot flashes per day (±10.25 Standard Deviation)
Elinzanetant 120 mg14.66 Hot flashes per day (±11.08 Standard Deviation)
Placebo - Elinzanetant 120 mg-7.24 Hot flashes per day (±8.49 Standard Deviation)
Placebo - Elinzanetant 120 mg16.16 Hot flashes per day (±11.15 Standard Deviation)
NCT05099159Hot FlashesMean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD)
From baseline to Week 4
Elinzanetant 120 mg-8.58 Hot Flashes per day (±9.16 Standard Deviation)
Elinzanetant 120 mg14.66 Hot Flashes per day (±11.08 Standard Deviation)
Placebo - Elinzanetant 120 mg16.16 Hot Flashes per day (±11.15 Standard Deviation)
Placebo - Elinzanetant 120 mg-6.07 Hot Flashes per day (±8.91 Standard Deviation)
NCT05099159Hot FlashesMean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD)
From baseline to Week 12
Elinzanetant 120 mg-0.97 Units on a scale (±0.78 Standard Deviation)
Elinzanetant 120 mg2.53 Units on a scale (±0.24 Standard Deviation)
Placebo - Elinzanetant 120 mg-0.65 Units on a scale (±0.67 Standard Deviation)
Placebo - Elinzanetant 120 mg2.54 Units on a scale (±0.24 Standard Deviation)
NCT05099159Hot FlashesMean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD)
From baseline to Week 4
Elinzanetant 120 mg-0.75 Units on a scale (±0.68 Standard Deviation)
Elinzanetant 120 mg2.53 Units on a scale (±0.24 Standard Deviation)
Placebo - Elinzanetant 120 mg2.54 Units on a scale (±0.24 Standard Deviation)
Placebo - Elinzanetant 120 mg-0.53 Units on a scale (±0.55 Standard Deviation)
NCT05587296
OASIS-4
Hot FlashesMean Change in Frequency of Moderate to Severe HFs From Baseline to Week 12 (Assessed by HFDD)
Baseline to Week 12
Elinzanetant (BAY3427080)11.41 hot flashes per day (±6.89 Standard Deviation)
Elinzanetant (BAY3427080)-7.76 hot flashes per day (±6.17 Standard Deviation)
Placebo - Elinzanetant (BAY3427080)-4.20 hot flashes per day (±6.06 Standard Deviation)
Placebo - Elinzanetant (BAY3427080)11.52 hot flashes per day (±6.43 Standard Deviation)
NCT05587296
OASIS-4
Hot FlashesMean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD])
Baseline to Week 4
Elinzanetant (BAY3427080)-6.51 hot flashes per day (±6.13 Standard Deviation)
Elinzanetant (BAY3427080)11.41 hot flashes per day (±6.89 Standard Deviation)
Placebo - Elinzanetant (BAY3427080)11.52 hot flashes per day (±6.43 Standard Deviation)
Placebo - Elinzanetant (BAY3427080)-3.04 hot flashes per day (±5.04 Standard Deviation)

Publications by year

2025–2025: 4 publications.

2025
4

Publications by indication

Hot Flashes (4)

  • Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials.
    JAMA · 2025 · PMID 39172446 · NCT05042362
  • Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial.
    JAMA Intern Med · 2025 · PMID 40920404 · NCT05030584
  • The Effects of Elinzanetant on Simulated Driving Performance in Healthy Women: A Randomized Phase I Study.
    Clin Transl Sci · 2025 · PMID 40569207 · NCT06219902
  • Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer.
    N Engl J Med · 2025 · PMID 40454634 · NCT05587296

Publications by journal

  • JAMA1 paper
  • JAMA Intern Med1 paper
  • Clin Transl Sci1 paper
  • N Engl J Med1 paper

Trial-results highlights

Clinical trials have investigated Elinzanetant (BAY3427080) for its effect on moderate to severe hot flashes. In the NCT05030584 (OASIS-3) study, the mean change in frequency of moderate to severe hot flashes from baseline to week 12 was -5.40 hot flashes for the Elinzanetant arm (from a baseline of 6.71 hot flashes) and -3.50 hot flashes for the placebo arm (from a baseline of 6.81 hot flashes). The NCT05042362 (OASIS-1) trial reported a mean change in frequency of moderate to severe hot flashes from baseline to week 12 of -8.74 hot flashes per day for the Elinzanetant 120 mg arm (from a baseline of 13.38 hot flashes per day) and -5.53 hot flashes per day for the placebo arm (from a baseline of 14.26 hot flashes per day). In NCT05099159, the mean change in frequency of moderate to severe hot flashes from baseline to week 12 was -9.96 hot flashes per day for the Elinzanetant 120 mg arm (from a baseline of 14.66 hot flashes per day) and -7.24 hot flashes per day for the placebo arm (from a baseline of 16.16 hot flashes per day).

For earlier results, in NCT05042362 (OASIS-1), the mean change in frequency of moderate to severe hot flashes from baseline to week 4 was -7.48 hot flashes per day for the Elinzanetant 120 mg arm (from a baseline of 13.38 hot flashes per day) and -4.37 hot flashes per day for the placebo arm (from a baseline of 14.26 hot flashes per day). In NCT05099159, the mean change in frequency of moderate to severe hot flashes from baseline to week 4 was -8.58 hot flashes per day for the Elinzanetant 120 mg arm (from a baseline of 14.66 hot flashes per day) and -6.07 hot flashes per day for the placebo arm (from a baseline of 16.16 hot flashes per day).

Regarding the severity of moderate to severe hot flashes, in NCT05042362 (OASIS-1), the mean change from baseline to week 12 was -0.95 units on a scale for the Elinzanetant 120 mg arm (from a baseline of 2.56 units) and -0.55 units on a scale for the placebo arm (from a baseline of 2.53 units). At week 4, the mean change was -0.73 units on a scale for the Elinzanetant 120 mg arm (from a baseline of 2.56 units) and -0.39 units on a scale for the placebo arm (from a baseline of 2.53 units). In NCT05099159, the mean change in severity from baseline to week 12 was -0.97 units on a scale for the Elinzanetant 120 mg arm (from a baseline of 2.53 units) and -0.65 units on a scale for the placebo arm (from a baseline of 2.54 units). All values presented are sourced from primary registry reporting, and individual papers should be consulted for clinical decisions.

All Elinzanetant (BAY3427080) publications (4)

2025 (4 papers)

  1. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials.
    Pinkerton JV, Simon JA, Joffe H, et al. · JAMA · 2025 · Derived
    PubMed: PMID 39172446 · NCT05042362 (OASIS-1) · Hot Flashes
  2. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial.
    Panay N, Joffe H, Maki PM, et al. · JAMA Intern Med · 2025 · Derived
    PubMed: PMID 40920404 · NCT05030584 (OASIS-3) · Hot Flashes
  3. The Effects of Elinzanetant on Simulated Driving Performance in Healthy Women: A Randomized Phase I Study.
    Francke K, Klein S, Burke J, et al. · Clin Transl Sci · 2025 · Derived
    PubMed: PMID 40569207 · NCT06219902 · Hot Flashes
  4. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer.
    Cardoso F, Parke S, Brennan DJ, et al. · N Engl J Med · 2025 · Derived
    PubMed: PMID 40454634 · NCT05587296 (OASIS-4) · Hot Flashes

Sources and methodology

  • Publications: ctgov.study_references (PubMed PMIDs auto-attached by ClinicalTrials.gov to each trial), reference types RESULT, DERIVED, and BACKGROUND.
  • Per-arm outcome values: ctgov.outcome_measurements joined to ctgov.design_outcomes where outcome_type = 'PRIMARY', restricted to phase PHASE3 and PHASE2/PHASE3.
  • Publication metadata (title, journal, year, authors): PubMed E-utilities efetch.fcgi
  • Data freshness: Tue, 26 May 2026 17:57:53 GMT.
This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).