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Drug

Fezolinetant

Approved · EMA
Emerging researchLate-stage development

Also known as Veozah.

RxNorm2637134ChEMBLCHEMBL3608680UNII83VNE45KXX
1
Research papers
6
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Randomized Phase II Study to Evaluate the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy

Clinical trial2026-06-02Results expected Q1 2028 · ClinicalTrials.gov

Fezolinetant and Vascular Health and Brain Health

Clinical trial2026-05-26Results expected Q4 2029 · ClinicalTrials.gov

A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)

Clinical trial2026-05-05Results expected Q4 2027 · ClinicalTrials.gov

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

Clinical trial2026-04-30Results expected Q4 2029 · ClinicalTrials.gov

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Investigate the Long Term Safety of Fezolinetant in Japanese Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Clinical trial2026-03-19Completed · ClinicalTrials.gov

A Phase 2, Randomized, Placebo-controlled, 12-week, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Chinese Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Clinical trial2026-03-05Completed · ClinicalTrials.gov

Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Androgen-Deprivation Therapy in Men With Prostate Cancer (FLASH): A Phase 2 Study

Clinical trial2026-02-05Results expected Q1 2027 · ClinicalTrials.gov

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant in Japanese Women Experiencing Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Clinical trial2025-12-18Completed · ClinicalTrials.gov

Drug Safety Update: Fezolinetant▼(Veoza): risk of liver injury; new recommendations to minimise risk

Regulatory2025-04-10MHRA

Approval: Veoza (EMA)

Regulatory2023-12-07EMA

Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial.

Research2019-12-01The Journal of clinical endocrinology and metabolism

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fezolinetant
Aliases & brands
Veozah
RxNorm CUI
2637134
ChEMBL ID
CHEMBL3608680
UNII
83VNE45KXX
Regulatory jurisdictions
emamhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-12-07
Latest approval
2023-12-07
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2023-12-07Approval
Approval: Veoza (EMA)

Indication: Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2025-04-10Safety communicationSafety
Drug Safety Update: Fezolinetant▼(Veoza): risk of liver injury; new recommendations to minimise risk
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

23 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
23
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
5
Recruiting
11
Late-stage (III+)
16
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 23
Phase 14Phase 28Phase 2 / 31Phase 310

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

RecruitingPH II/IIIUniversity of Colorado, Denvern=2002030

Fezolinetant and Vascular Health and Brain Health

Not yet recruitingPH IIIRebecca Thurstonn=2202029

A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy

Active, not recruitingPH IIIAstellas Pharma Global Development, Inc.n=9822028

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Investigate the Long Term Safety of Fezolinetant in Japanese Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

CompletedPH IIIAstellas Pharma Incn=2772026

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant in Japanese Women Experiencing Vasomotor Symptoms (Hot Flashes) Associated With Menopause

CompletedPH IIIAstellas Pharma Incn=4102025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Investigate the Long Term Safety of Fezolinetant in Japanese Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

CompletedPH IIIAstellas Pharma Incn=2772026

A Phase 2, Randomized, Placebo-controlled, 12-week, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Chinese Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

CompletedPH IIAstellas Pharma Global Development, Inc.n=1502026

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant in Japanese Women Experiencing Vasomotor Symptoms (Hot Flashes) Associated With Menopause

CompletedPH IIIAstellas Pharma Incn=4102025

A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy

CompletedPH IIIAstellas Pharma Global Development, Inc.n=4532023

A Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Select the Optimal Dose(s) of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause in Japan

CompletedPH IIAstellas Pharma Incn=1472022

A Single-Arm Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women in China Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

CompletedPH IIIAstellas Pharma China, Inc.n=1502022

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial.

The Journal of clinical endocrinology and metabolism · 2019 · 85 cites
Recent papers

Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial.

The Journal of clinical endocrinology and metabolism · 2019 · 85 cites
Journals, researchers & institutions
Top journals
  • The Journal of clinical endocrinology and metabolism1
Leading researchers
  • Combalbert J1
  • Depypere H1
  • Donders G1
  • Fraser GL1
  • Hoveyda HR1
  • Ramael S1
  • Sieprath P1
  • Timmerman D1
Leading institutions
free-text, unnormalised
  • Breast and Menopause Clinic1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.