Rankings / Hormones & Endocrine
Fezolinetant (Veozah)
Hormones & Endocrine · NK3 receptor antagonist (non-hormonal)
Tier B
Bottom line
Read Off Label grades Fezolinetant (Veozah) as B (6.8/10) based on strong evidence, high benefit magnitude, and a med-risk safety profile.
First-in-class non-hormonal therapy for moderate-to-severe vasomotor symptoms (hot flashes/night sweats) of menopause.
Studied, labeled, or reported-use context: 45 mg PO once daily — Rx; not individualized guidance.
What the evidence says
First-in-class non-hormonal therapy for moderate-to-severe vasomotor symptoms (hot flashes/night sweats) of menopause. Its non-estrogen mechanism is relevant to clinical contexts involving a breast-cancer history or labeled contraindications to estrogen. Liver-enzyme monitoring requirement is the practical adoption barrier. Astellas; brand Veozah. A 2026 review of pooled post-marketing data raised an emerging, not-yet-confirmed signal of increased non-benign neoplasms — suggestive only, causality not established, long-term follow-up needed.
Mechanism
Selective neurokinin 3 (NK3) receptor antagonist; blocks NK3 signaling on KNDy neurons in the hypothalamic thermoregulatory center; corrects the dysregulated firing pattern that drives hot flashes after estrogen decline
Studied, labeled, or reported dose & route
45 mg PO once daily
This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.
Citations
- DOI · 10.1007/s40265-025-02231-8
- PubMed · PMID 40299712
- fda.gov
- DOI · 10.1210/jendso/bvag082
- ClinicalTrials.gov · NCT06206408
- PubMed · PMID 40482564
- PubMed · PMID 41493963
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Common questions
- What does the evidence show about Fezolinetant (Veozah)'s effects?
- Read Off Label rates the evidence for Fezolinetant (Veozah) as Strong and the benefit magnitude as high, producing an overall grade of B (6.8/10). First-in-class non-hormonal therapy for moderate-to-severe vasomotor symptoms (hot flashes/night sweats) of menopause.
- What safety findings are reported for Fezolinetant (Veozah)?
- Fezolinetant (Veozah) has a med risk profile in the database. Med (transient ALT/AST elevations 2-3% — REQUIRES baseline & monthly liver monitoring per FDA boxed warning; headache, abdominal pain, insomnia) Legal status: Rx (FDA-approved 2023).
- What doses or routes are reported for Fezolinetant (Veozah)?
- 45 mg PO once daily This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
- How does Fezolinetant (Veozah) work?
- Selective neurokinin 3 (NK3) receptor antagonist; blocks NK3 signaling on KNDy neurons in the hypothalamic thermoregulatory center; corrects the dysregulated firing pattern that drives hot flashes after estrogen decline
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.