Veozah

(Fezolinetant)

ApprovedSmall molecule

Fezolinetant is used to treat moderate to severe hot flashes and night sweats that occur during menopause in women.[2] Veozah is currently approved and in use across 5 indications[4].[1]

Veozah is one of 151 small molecule programs targeting Menopause. It is currently in Approved.

Indications

Total Trials

Active Trials

150

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

MenopauseActive, not recruiting

Kidney DiseaseApproved

Liver DiseaseApproved

Prostate CancerRecruiting

Hot FlashesNot yet recruiting

MenopausePhase 3

Active, not recruiting

Kidney DiseaseApproved

Approved

Liver DiseaseApproved

Approved

Prostate CancerPhase 2

Recruiting

Hot FlashesPhase 3

Not yet recruiting

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Veozah

Astellas

Approved

2 2

Paraplatin

AAvyxa

Phase 3

25 3

Alinamin

Roche

Phase 3

6 4

GM-CSF

YY-mAbs Therapeutics

Phase 3

8 5

Semaglutide Pen Injector

UUniversitaire Ziekenhuizen KU Leuven

Phase 3

1 6

Pasritamig

Johnson & Johnson

Phase 3

1 7

Lupron Depot

RRepros Therapeutics Inc.

Phase 3

2 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 10

Duragesic

CCephalon

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Prostate Cancer

NCT06972875

Q2 2027

Phase 1Recruiting

Prostate Cancer

NCT07783282

Q1 2028

Phase 2Recruiting

Breast Cancer Early Stage Breast Cancer (stage 1-3)

NCT06917313

Phase 2Recruiting

Vasomotor Symptoms

NCT07568236

Q2 2028

Phase 3Recruiting

Hot Flashes

NCT07829653

Phase 3Active, not recruiting

Hot Flashes

NCT06440967

Clinical

Trials by Indication[1]

Hot flashes16 trials

A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

Completed· Astellas logo

Astellas·Phase 3·NCT05033886·453 enrolled

Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes

Completed·OOgeda S.A.·Phase 2·NCT05419908·87 enrolled

A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause

Completed· Astellas logo

Astellas·Phase 3·NCT04234204·302 enrolled

Show 13 more trials

A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause

Completed· Astellas logo

Astellas·Phase 3·NCT04003155·527 enrolled

A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause

Completed· Astellas logo

Astellas·Phase 3·NCT06206408·410 enrolled

A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)

Completed· Astellas logo

Astellas·Phase 2·NCT03192176·356 enrolled

A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Active, not recruiting· Astellas logo

Astellas··NCT06049797·999 enrolled

A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause

Completed· Astellas logo

Astellas·Phase 3·NCT04003389·1,831 enrolled

A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2

Completed· Astellas logo

Astellas·Phase 3·NCT04003142·501 enrolled

A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

Completed· Astellas logo

Astellas·Phase 2·NCT05034042·147 enrolled

A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause

Completed· Astellas logo

Astellas·Phase 2·NCT06812754·150 enrolled

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

Recruiting·UUniversity of Colorado, Denver·Preclinical·NCT06975111·200 enrolled

A Phase 3, Single-arm, 12-week Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Indian Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Recruiting· Astellas logo

Astellas·Phase 3·NCT07829653·100 enrolled

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 recruiting· Astellas logo

Astellas·Phase 3·NCT06440967·982 enrolled

Fezolinetant and Vascular Health and Brain Health

Not yet recruiting·RRebecca Thurston·Phase 3·NCT07606664·220 enrolled

Fezolinetant Experience for the Treatment of Vasomotor Symptoms Associated With Menopause Among Women in a German Real-life Setting

Completed· Astellas logo

Astellas··NCT07455812·105 enrolled

Female3 trials

A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants

Completed· Astellas logo

Astellas·Phase 1·NCT04641260·16 enrolled

A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants

Completed· Astellas logo

Astellas·Phase 1·NCT04277624·22 enrolled

A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT04793204·16 enrolled

Menopause2 trials

A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause

Completed· Astellas logo

Astellas·Phase 3·NCT04451226·150 enrolled

A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause

Active, not recruiting· Astellas logo

Astellas·Phase 3·NCT06206421·277 enrolled

Prostate Cancer2 trials

Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer

Recruiting·UUniversity of Vermont·Phase 2·NCT06972875·32 enrolled

A Phase 1 Open-label Study to Evaluate the Effect of Enzalutamide, Apalutamide and Bicalutamide on the Pharmacokinetics of Fezolinetant in Male Participants With Prostate Cancer

Recruiting· Astellas logo

Astellas·Phase 1·NCT07783282·56 enrolled

Moderate Hepatic Impairment1 trial

A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function

Completed· Astellas logo

Astellas·Phase 1·NCT04482270·26 enrolled

4 more indications

Renal Impairment1 trial

A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function

Completed· Astellas logo

Astellas·Phase 1·NCT04476849·27 enrolled

Breast Cancer1 trial

Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial

Terminated·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT06617455·9 enrolled

Breast Cancer Early Stage Breast Cancer (Stage 1-3)1 trial

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

Recruiting·YYale University·Phase 2·NCT06917313·92 enrolled

Vasomotor Symptoms1 trial

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

Recruiting·CChinese University of Hong Kong·Phase 2·NCT07568236·54 enrolled

Regulatory

FDA Approval Timeline[5]

May 12, 2023

VEOZAH

NDA NDA216578

May 12, 2023

VEOZAH

NDA NDA216578

Aug 31, 2024

VEOZAH

NDA NDA216578

Dec 16, 2024

VEOZAH

NDA NDA216578

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Fezolinetant. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Veozah drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fezolinetant compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fezolinetant. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216578). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Veozah. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Neurokinin 3 Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Astellas

Patent Landscape[6]

Patent Cliff

Apr 4, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8871761Apr 4, 2031

10836768Mar 28, 2034

9987274Mar 28, 2034

9422299Mar 28, 2034

Veozah

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Hot flashes16 trials

Female3 trials

Menopause2 trials

Prostate Cancer2 trials

Moderate Hepatic Impairment1 trial

Renal Impairment1 trial

Breast Cancer1 trial

Breast Cancer Early Stage Breast Cancer (Stage 1-3)1 trial

Vasomotor Symptoms1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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