Fezolinetant for Hot Flashes

(FLASH-CV: Trial)

Not yet recruiting at 1 trial location

Overseen By Kamila Bielawski

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Cytochrome inhibitors

Disqualifiers: Cancer, Renal, Liver, Lung, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug fezolinetant can improve blood vessel health in women experiencing moderate to severe hot flashes. The study will compare fezolinetant to a placebo (a pill with no active drug) over 12 weeks. It seeks women who are peri- or post-menopausal and have health issues such as obesity, high blood pressure, or high blood sugar. Women whose frequent hot flashes affect daily life and who have these health concerns might be a good fit. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are using strong or moderate cytochrome P450 1A2 inhibitors. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that fezolinetant is likely to be safe for humans?

Research shows that fezolinetant is generally easy for patients to handle. Studies have found that it effectively reduces moderate to severe hot flashes, with few side effects reported. In one study, patients taking fezolinetant experienced fewer hot flashes without any major safety issues. Another study found it to be well-tolerated over six months, with no serious side effects. Overall, evidence suggests that fezolinetant is safe for treating hot flashes, with most patients managing it well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hot flashes, which often include hormone replacement therapy, Fezolinetant offers a non-hormonal alternative. Researchers are excited because Fezolinetant works by blocking the neurokinin B receptor, a key player in regulating body temperature. This novel approach could provide relief without the hormonal side effects associated with current therapies, offering a safer option for many women.

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

Research has shown that fezolinetant, which participants in this trial may receive, reduces the frequency and severity of hot flashes in women. Studies found that women taking fezolinetant experienced fewer and less intense hot flashes within 4 to 12 weeks compared to those on a placebo. Additionally, fezolinetant appears to improve sleep and work performance in daily life. These findings suggest it could be a promising option for women with moderate to severe hot flashes. ^{3 5 6 7 8}

Who Is on the Research Team?

Emily Lau, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for women experiencing moderate to severe hot flashes. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and may be required to give informed consent.

Inclusion Criteria

I experience frequent or severe hot flashes or night sweats.

I have cardiometabolic disease with at least two of the listed conditions.

I am between 40 and 65 years old.

Exclusion Criteria

Inability to provide informed consent or comply with study protocol

Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN)

I have serious health issues like cancer, kidney, liver, or lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fezolinetant 45 mg or placebo daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fezolinetant

Trial Overview The study is testing fezolinetant against a placebo to see if it can improve blood vessel health in women with hot flashes. Participants will receive either the drug or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: fezolinetant 45 mg daily for 12 weeks or elinzanetant 120 mg daily for 12 weeks Active Control 1 Intervention

Group II: Placebo daily for 12 weeks Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

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

The effectiveness and value of fezolinetant for moderate- ... Participants treated with fezolinetant also had a significantly greater reduction in VMS severity at 12 weeks, exceeding the MCID for reduction in severity (> ...

2. bmj.com bmj.com/content/387/bmj-2024-079525

Efficacy and safety of fezolinetant for moderate-severe ... Conclusions Fezolinetant was efficacious and well tolerated over a six month period for treating moderate-severe vasomotor symptoms in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211524001921

Effectiveness and safety of fezolinetant in alleviating ... Fezolinetant significantly reduces frequency/severity of menopausal symptoms. VMS episodes decrease, severity scores improve at 4/12 weeks. •. Fezolinetant ...

4. contemporaryobgyn.net contemporaryobgyn.net/view/fezolinetant-shows-significant-real-world-improvements-in-vasomotor-symptoms-sleep

Fezolinetant shows significant real-world improvements in ... Real-world data show fezolinetant improves vasomotor symptoms, sleep, and work productivity in postmenopausal women.

5. journals.lww.com journals.lww.com/greenjournal/fulltext/2025/03000/fezolinetant_and_elinzanetant_therapy_for.3.aspx

Fezolinetant and Elinzanetant Therapy for Menopausal ... In this meta-analysis, consistent results suggest that fezolinetant and elinzanetant are associated with beneficial outcomes in menopausal women with vasomotor ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38563867/

Efficacy and safety of fezolinetant for vasomotor symptoms ... Our study significantly favors fezolinetant over placebo regarding the primary efficacy outcomes of daily moderate to severe VMS frequency and severity.

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

Effect of fezolinetant on patient-reported quality-of-life ... Fezolinetant was shown to be efficacious and well tolerated for treating moderate to severe VMS associated with menopause in phase 3 studies, SKYLIGHT 1 and ...

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

Fezolinetant's efficacy and safety in treatment of vasomotor ... Fezolinetant is efficient and well-tolerated in the treatment of postmenopausal women with VMS. Introduction. Up to 80% of women in the United ...