{
  "abstract": "Background\n\nElinzanetant is a dual neurokinin (NK)-1 and NK-3 receptor antagonist approved for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause, or those caused by adjuvant endocrine therapy for breast cancer treatment.Methods\n\nIn this pooled safety analysis, safety data were pooled from four randomized, placebo-controlled studies: the phase IIb SWITCH-1 trial (2018-2019) and phase III OASIS-1-3 trials (2021-2024). All four studies were multicentre, multinational, double-blind trials that included postmenopausal women aged 40-65 years experiencing moderate-to-severe VMS due to natural or surgical menopause. Data were analysed exploratively. Assessments included frequency of treatment-emergent adverse events (TEAEs) over 12 and 52 weeks, and exposure-adjusted incidence rates (EAIRs, with 95% confidence intervals [CIs]) over 52 weeks. EAIRs were calculated by weighting event counts against total exposure time (person-years) across studies. Additionally, liver safety and incidence of neoplasms were evaluated.Findings\n\nThe 12-week pooled safety analysis set included 1519 participants: 765 participants in the elinzanetant 120 mg group and 754 participants in the placebo group. The 52-week pooled safety analysis set included 1113 participants in the elinzanetant 120 mg group and 754 participants in the placebo group. TEAEs occurred in 50·8% and 43·2% of participants in the elinzanetant 120 mg and the placebo groups, respectively, over 12 weeks; EAIRs were 196·61 (95% CI 181·33-213·18) and 209·00 (95% CI: 188·96-231·15) in the elinzanetant and placebo groups, respectively, over 52 weeks. The most common TEAEs reported with elinzanetant were headache, fatigue, and somnolence. Treatment discontinuation was low with elinzanetant (7·8%) but higher than placebo (3·6%) over 12 weeks; EAIRs were 14·95 (95% CI 11·99-18·62) and 10·96 (95% CI 7·87-15·27), respectively, over 52 weeks. There were no Hy's Law cases or indication of cholestatic injury. EAIRs of malignant tumors had overlapping CIs between treatment groups. No endometrial hyperplasia/malignancy was reported in either group.Interpretation\n\nThe overall safety profile of elinzanetant appeared favorable in 1113 women based on this exploratory pooled safety analysis. Future time-to-event analyses of TEAEs and real-world post-marketing data are warranted to better characterize the long-term safety profile of elinzanetant.Funding\n\nBayer.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 8,
  "authors": [
    {
      "name": "JoAnn V. Pinkerton",
      "orcid": "0000-0001-6707-3405"
    },
    {
      "name": "Maja Francuski"
    },
    {
      "name": "Rossella E. Nappi",
      "orcid": "0000-0003-1713-6396"
    },
    {
      "name": "James A. Simon"
    },
    {
      "name": "Chenshuang Lu"
    },
    {
      "name": "Senka Djordjevic"
    },
    {
      "name": "Christian Seitz"
    },
    {
      "name": "Nick Panay"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/0vxrae58r2agp.bib",
  "cited_by": 0,
  "doi": "10.1016/j.eclinm.2026.104250",
  "fulltext_url": "https://europepmc.org/articles/PMC13688456",
  "id": "0vxrae58r2agp",
  "issns": [
    "2589-5370"
  ],
  "landing_url": "https://linkinghub.elsevier.com/retrieve/pii/S2589537026005031",
  "language": "eng",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "http://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "3005|Pharmacovigilance and Adverse Drug Reactions"
    ]
  ],
  "openalex": "W7220838488",
  "pdf_url": "https://europepmc.org/articles/PMC13688456?pdf=render",
  "pmcid": "PMC13688456",
  "pmid": "42923369",
  "published": "2026-10-07",
  "publisher": "Elsevier BV",
  "ris": "https://research.draconitic.com/paper/0vxrae58r2agp.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:48Z",
      "native_id": "10.1016/j.eclinm.2026.104250",
      "source": "crossref",
      "url": "https://linkinghub.elsevier.com/retrieve/pii/S2589537026005031"
    },
    {
      "first_seen": "2026-10-30T12:20:36Z",
      "native_id": "MED:42923369",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42923369"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3005|Pharmacovigilance and Adverse Drug Reactions",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Safety and tolerability of elinzanetant: a pooled analysis from four randomized clinical trials",
  "title_text": "Safety and tolerability of elinzanetant: a pooled analysis from four randomized clinical trials",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:36Z",
  "url": "https://research.draconitic.com/paper/0vxrae58r2agp",
  "venue": "eClinicalMedicine",
  "versions": []
}