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 165 small molecule programs targeting Kidney Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

164

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Kidney DiseaseApproved

Liver DiseaseApproved

Breast CancerActive, not recruiting

Prostate CancerActive, not recruiting

Hot FlashesActive, not recruiting

Kidney DiseaseApproved

Approved

Liver DiseaseApproved

Approved

Breast CancerPhase 2

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Hot FlashesPhase 3

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Veozah

Astellas

Approved

2 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

Gemzar

GGynecologic Oncology Group

Preclinical

22 5

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 6

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 7

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 8

Chantix

PPrism Pharmaceuticals

Preclinical

1 9

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—10

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Active, not recruiting

Hot Flashes

NCT07455812

Q1 2027

Phase 2Recruiting

Prostate Cancer

NCT06972875

Q1 2028

Phase 2Recruiting

Breast Cancer

NCT06917313

Q2 2028

Phase 3Active, not recruiting

Hot Flashes

NCT06440967

Clinical

Trials by Indication[1]

Hot flashes13 trials

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

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 in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause

Active, not recruiting· Astellas logo

Astellas··NCT07455812·105 enrolled

Show 10 more trials

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

Completed· Astellas logo

Astellas·Phase 3·NCT06206408·410 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

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

Female3 trials

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

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

Completed· Astellas logo

Astellas·Phase 1·NCT04641260·16 enrolled

Menopause2 trials

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

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

Breast Cancer2 trials

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

FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy

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

Prostate Cancer1 trial

Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer

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

3 more indications

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

Women's Health1 trial

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

Not yet recruiting·UUniversity of Colorado, Denver·Phase 2/3·NCT06975111·200 enrolled

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

Regulatory

FDA Approval Timeline[5]

May 12, 2023

VEOZAH

NDA NDA216578

Sources

References

[1]
ClinicalTrials.gov — 24 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

Q3 2026

Q1 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Hot flashes13 trials

Female3 trials

Menopause2 trials

Breast Cancer2 trials

Prostate Cancer1 trial

Moderate Hepatic Impairment1 trial

Women's Health1 trial

Renal Impairment1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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