Fezolinetant for Hot Flashes

(Daylight Trial)

No longer recruiting at 108 trial locations

Overseen By Astellas Pharma Global Development

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Astellas Pharma Global Development, Inc.

Must not be taking: VMS therapies

Disqualifiers: Substance abuse, Tumor history, Liver disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether fezolinetant can reduce hot flashes in women undergoing menopause who cannot use hormone replacement therapy. Hot flashes are sudden, often intense, feelings of warmth that can disrupt daily life. Participants will take either fezolinetant or a placebo (a pill with no active medicine) daily for 24 weeks to assess the treatment's effectiveness. Women who may be suitable for this trial experience an average of 7 or more moderate to severe hot flashes daily and are unsuitable for hormone replacement therapy. Participants will track their symptoms using an app and attend regular check-ups throughout the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you do not use any therapies for hot flashes, including prescription, over-the-counter, or herbal treatments, before and during the study. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fezolinetant was tested in studies with over 1,100 women for a year. Most participants tolerated it well, though some experienced liver-related side effects. In 1.5-2.3% of those taking the treatment, liver enzyme levels increased. These enzymes, found in the blood, indicate liver health. The increases were usually mild, temporary, and often resolved even while continuing the treatment.

However, the FDA reported rare cases of serious liver injury. Due to this, a liver function test is recommended before starting the treatment. This involves a simple blood test to assess liver function. While these side effects might seem concerning, they were uncommon. Overall, fezolinetant is considered to have a generally acceptable safety profile, especially compared to hormone replacement therapy, which some women cannot use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fezolinetant is unique because it targets neurokinin-3 receptors in the brain, which play a key role in regulating body temperature and are implicated in hot flashes. Most current treatments for menopause symptoms, such as hormone replacement therapy (HRT), focus on balancing estrogen levels, which can have their own set of risks and side effects. Researchers are excited about fezolinetant because it offers a non-hormonal approach, potentially reducing side effects associated with hormonal treatments. This mechanism makes it a promising alternative for women who cannot or prefer not to use hormone-based therapies.

What evidence suggests that fezolinetant might be an effective treatment for hot flashes?

Research shows that fezolinetant, which participants in this trial may receive, can greatly reduce hot flashes in women going through menopause. Studies have found that 81–95% of women taking fezolinetant experienced their hot flashes being cut in half or more. Fezolinetant also improves sleep and overall quality of life compared to a placebo. In one study, participants taking fezolinetant had much better results than those taking a placebo, with a 63% higher chance of improvement. These findings suggest that fezolinetant effectively eases the discomfort of hot flashes. ^{6 7 8 9 10}

Who Is on the Research Team?

Executive Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Had bilateral oophorectomy >= 6 weeks prior to the screening visit (with or without hysterectomy)

Had hysterectomy without oophorectomy and who meets the biochemical criterion of menopause (FSH > 40 IU/L).

Participant has a negative serology panel (including hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody screens).

Exclusion Criteria

You have a history of severe allergic reactions or intolerance to the study drug or any of its components.

Participant uses a prohibited therapy for VMS (e.g., prescription, over-the-counter or herbal) prior to screening and for the duration of treatment with investigational product (IP).

Participant has endometrial thickness > 8 mm on the locally read screening transvaginal ultrasound (TVU) or any clinically significant findings that that would make the participant ineligible.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fezolinetant or placebo tablets daily for 24 weeks to assess efficacy and safety in reducing hot flashes

24 weeks

Visits at Weeks 2, 4, 8, 12, 16, 20, 24

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final check-up at Week 27

3 weeks

1 visit (in-person) at Week 27

What Are the Treatments Tested in This Trial?

Interventions

• Fezolinetant
• Placebo

How Is the Trial Designed?

Group I: fezolinetant Experimental Treatment 1 Intervention

Participants receive fezolinetant 45 milligrams (mg) (one 30 mg tablet and one 15 mg tablet) orally once daily for 24 weeks of treatment.

Group II: placebo Placebo Group 1 Intervention

Participants receive placebo matched to fezolinetant tablets orally once daily for 24 weeks of treatment.

Fezolinetant is already approved in United States, European Union for the following indications:

Approved in United States as Veozah for:

• Moderate to severe vasomotor symptoms due to menopause

Approved in European Union as Veoza for:

• Hot flushes (vasomotor symptoms) associated with menopause

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Citations

1. veozahhcp.com veozahhcp.com/efficacy/data-over-time

Data over time of VEOZAH™ (fezolinetant) tablets | For HCPs In Trial 2, results were statistically significantly superior compared to placebo at the 0.05 level with multiplicity adjustment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10387909/

The effectiveness and value of fezolinetant for moderate- ... Pooled data from the Skylight trials reported that fezolinetant significantly improved scores on the Menopause Quality of Life Questionnaire (MENQoL) compared ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224002548

Effect of fezolinetant on patient-reported quality-of-life ... Fezolinetant improved patient-reported outcomes in relation to sleep disturbance and general quality of life versus placebo.

4. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/09000/fda_approves_veozah__fezolinetant__for_menopausal.4.aspx

FDA approves Veozah (Fezolinetant) for menopausal ... Approximately 81–95% of participants receiving fezolinetant experienced a 50% or greater reduction in VMS from baseline. The onset of symptom ...

5. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02279-y

Fezolinetant's efficacy and safety in treatment of vasomotor ... Compared to the placebo group, the fezolinetant group had a significantly higher incidence of much better outcome [RR = 1.63, 95% CI (1.30, 2.04) ...

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due

FDA adds warning about rare occurrence of serious liver ... FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause.

7. veozahhcp.com veozahhcp.com/safety

Safety of VEOZAH™ (fezolinetant) tablets | For HCPs The safety of VEOZAH was evaluated in three 52-week clinical trials with 1100 women receiving VEOZAH · Study designs · Hepatotoxicity · Effects on endometrium ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39739195/

Safety of Fezolinetant for Treatment of Moderate to Severe ... Elevations in liver transaminases occurred in 1.5-2.3% of fezolinetant-treated participants, were typically asymptomatic and transient, resolved on treatment or ...

9. fda.gov fda.gov/media/181764/download

FDA Drug Safety Communication To help FDA track safety issues with medicines, report adverse events involving Veozah. (fezolinetant) or other medicines to the FDA MedWatch ...

10. ema.europa.eu ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-veoza-fezolinetant-risk-drug-induced-liver-injury-new-recommendations-monitoring-liver-function-during-treatment_en.pdf

fezolinetant Veoza DHPC - European Medicines Agency Serious liver injury has been observed with fezolinetant. • Liver function tests (LFTs) must be performed prior to initiation of fezolinetant. Treatment with ...