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Fezolinetant

Fezolinetant is an investigational drug being studied as a potential treatment for vasomotor symptoms (hot flashes) associated with menopause. This article summarizes key findings from several clinical trials evaluating the safety, efficacy, and pharmacokinetics of fezolinetant in different populations of women experiencing menopausal hot flashes.

Table of Contents

What is Fezolinetant?

Fezolinetant is a new medication designed to treat hot flashes in women going through menopause. It’s also known by other names such as ESN364, ASP2693, and VEOZAH[1][2][3]. Menopause is a normal part of a woman’s life when her menstrual periods stop, typically occurring between the ages of 45 and 55. During this time, many women experience uncomfortable symptoms, with hot flashes being one of the most common and disruptive.

Hot flashes, also called vasomotor symptoms (VMS), are sudden feelings of warmth that spread over the body, often accompanied by sweating and reddening of the skin. These can significantly impact a woman’s quality of life, disturbing sleep and daily activities[4].

How Does Fezolinetant Work?

Fezolinetant works differently from traditional hormone replacement therapy (HRT). It targets a specific part of the brain called the hypothalamus, which is involved in regulating body temperature. The medication blocks a substance in the brain called neurokinin B, which is thought to play a role in triggering hot flashes[1].

By blocking neurokinin B, fezolinetant aims to reduce both the frequency (how often they occur) and severity (how intense they are) of hot flashes. This approach is unique because it doesn’t involve adding hormones to the body, which is how traditional HRT works[4].

What Conditions Does Fezolinetant Treat?

Fezolinetant is specifically designed to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. It may be particularly useful for women who:

  • Experience frequent and intense hot flashes that disrupt their daily life
  • Cannot use or prefer not to use hormone replacement therapy
  • Are looking for an alternative to current treatments for menopausal symptoms

While the primary focus is on hot flashes, some studies are also looking at how fezolinetant might affect other menopausal symptoms such as sleep disturbances and overall quality of life[4].

Clinical Trials and Research

Fezolinetant has been the subject of several clinical trials to test its effectiveness and safety. These trials have involved women from different countries, including the United States, China, and Japan[5][3][6]. The studies have looked at various aspects of the medication, including:

  • How well it reduces the frequency and severity of hot flashes
  • Its effects on sleep quality
  • How it impacts overall quality of life for menopausal women
  • Its safety profile and potential side effects
  • How the body processes the medication (pharmacokinetics)

Many of these studies have shown promising results, with significant reductions in hot flash frequency and severity for many women taking fezolinetant compared to those taking a placebo (a dummy pill with no active medication)[2].

Dosage and Administration

Fezolinetant is taken orally, usually as a tablet once daily. The exact dosage can vary depending on the specific formulation and the individual patient’s needs. In clinical trials, doses ranging from 30 to 45 milligrams per day have been studied[5][4].

It’s important to note that the medication should be taken exactly as prescribed by your healthcare provider. They will determine the right dose for you based on your individual circumstances and how you respond to the treatment.

Side Effects and Safety

Like all medications, fezolinetant can potentially cause side effects. Clinical trials have been monitoring these closely to ensure the safety of the medication. Some of the potential side effects that have been reported include:

  • Headache
  • Nausea
  • Dizziness
  • Fatigue

However, it’s important to remember that not everyone experiences side effects, and many women in the trials tolerated the medication well. The studies are also looking at long-term safety to understand any potential risks of taking fezolinetant for extended periods[1][6].

Who Can Take Fezolinetant?

Fezolinetant is designed for women experiencing moderate to severe hot flashes associated with menopause. It may be particularly suitable for women who:

  • Cannot take hormone replacement therapy due to medical reasons
  • Prefer not to use hormone-based treatments
  • Have not found relief with other treatments for hot flashes

However, like all medications, fezolinetant may not be suitable for everyone. Women with certain medical conditions or those taking specific medications may need to avoid fezolinetant or use it with caution. Always consult with your healthcare provider to determine if fezolinetant is right for you[4].

Future Developments

As of 2023, fezolinetant has been approved for use in the United States under the brand name VEOZAH. However, it is still undergoing further studies in other parts of the world, including Asia. Researchers are continuing to study its long-term effects and its potential use in different populations of women[3][6].

These ongoing studies will help to further our understanding of fezolinetant and potentially expand its use to help more women manage their menopausal symptoms effectively.

Aspect Details
Drug Name Fezolinetant (also known as ESN364, ASP2693, VEOZAH™)
Purpose Treatment of vasomotor symptoms (hot flashes) associated with menopause
Administration Oral tablet, taken daily
Trial Phases Phase 1, 2, and 3 studies
Study Populations Healthy volunteers, menopausal women with hot flashes, including specific studies in Chinese and Japanese women
Key Outcomes Measured Reduction in frequency and severity of hot flashes, safety profile, pharmacokinetics, effects on endometrial thickness
Safety Assessments Adverse events, laboratory tests, vital signs, ECG, endometrial thickness (for women with a uterus)
Comparator Placebo in most studies
Study Durations Ranging from single-dose studies to 52-week long-term safety studies
Special Populations Studied Women with renal impairment, hepatic impairment

FAQ

  • What is fezolinetant? Fezolinetant is an investigational drug being studied as a potential non-hormonal treatment for vasomotor symptoms (hot flashes) associated with menopause. It is taken orally and works differently than hormone replacement therapy.
  • How effective is fezolinetant in reducing hot flashes? Clinical trials have shown promising results for fezolinetant in reducing both the frequency and severity of hot flashes in menopausal women. Some studies reported significant reductions in hot flash scores and frequency compared to placebo after 12 weeks of treatment.
  • What are the most common side effects of fezolinetant? The clinical trials monitored for adverse events, but specific common side effects were not detailed in the provided information. The studies focused on assessing the overall safety and tolerability of fezolinetant compared to placebo.
  • How is fezolinetant taken? In the clinical trials, fezolinetant was taken orally, usually as a daily tablet. The dosage varied between studies, ranging from once daily to twice daily administration, depending on the specific trial design.
  • Is fezolinetant approved for use? As of the information provided in these trials, fezolinetant was still being investigated. It has been approved in some countries, including the US, but was still undergoing studies for approval in other regions like Asia.

Ongoing Clinical Trials on Fezolinetant

  • Study of Fezolinetant for Hot Flashes in Women with Hormone Receptor-Positive Breast Cancer Receiving Hormone Therapy

    Not recruiting

    3 1
    Investigated drugs:
    Czechia Denmark France Germany Hungary Italy +3

Glossary

  • Vasomotor Symptoms (VMS): Commonly known as hot flashes or night sweats, these are sudden feelings of warmth, usually most intense over the face, neck and chest, often accompanied by sweating.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Endometrial Thickness: A measure of the thickness of the lining of the uterus, which can be assessed using transvaginal ultrasound.
  • Transvaginal Ultrasound (TVU): An imaging technique where a probe is inserted into the vagina to create detailed pictures of the reproductive organs using sound waves.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Hormone Replacement Therapy (HRT): A treatment used to relieve symptoms of menopause by replacing hormones that are at a lower level as women approach menopause.
  • Electrocardiogram (ECG): A test that measures the electrical activity of the heart.
  • Menopause: The time in a woman's life when menstrual periods permanently stop, marking the end of the reproductive years.
  • Biomarker: A measurable indicator of a biological state or condition, often used to assess the effects of a drug on the body.

References

  1. https://clinicaltrials.gov/study/NCT04451226
  2. https://clinicaltrials.gov/study/NCT05419908
  3. https://clinicaltrials.gov/study/NCT06206408
  4. https://clinicaltrials.gov/study/NCT05033886
  5. https://clinicaltrials.gov/study/NCT04793204
  6. https://clinicaltrials.gov/study/NCT06206421