Veozah (fezolinetant)

To treat moderate to severe hot flashes caused by menopause Press Release Drug Trials Snapshot

FDA Approval: 5/12/2023

Research Synopsis

  • Fezolinetant (Veozah) is a neurokinin 3 receptor antagonist showing promise as a non-hormonal treatment for menopausal vasomotor symptoms (VMS), which includes hot flashes and night sweats.
  • A phase 2 trial demonstrated that fezolinetant significantly reduced the severity and frequency of VMS in menopausal women compared to placebo, improving overall quality of life.
  • Phase 2b trials, including the VESTA study, confirmed that fezolinetant effectively alleviated VMS while maintaining a favorable safety profile, with gastrointestinal disorders being the most common side effect.
  • The recent SKYLIGHT 1 phase 3 trial involved over 2,200 women and further validated the efficacy of fezolinetant, highlighting its potential as a widely accepted treatment for VMS in women seeking non-hormonal options.
  • Safety evaluations from the research indicated that fezolinetant had similar adverse event rates compared to placebo, with minimal cases of serious conditions such as endometrial hyperplasia and malignancy.
  • Research emphasized the importance of neurokinin signaling in reproductive hormone regulation, establishing a scientific basis for targeting NK3 receptors as a therapeutic strategy for menopause-related symptoms.
  • Systematic reviews and comparative studies positioned fezolinetant favorably against other non-hormonal therapies, with some reports indicating superior outcomes to traditional treatments like serotonin norepinephrine reuptake inhibitors (SNRIs).
  • Despite its efficacy, expert guidelines affirm hormone therapy remains the most effective method for managing VMS, but cases like fezolinetant showcase valuable progress in developing alternatives for women who cannot or prefer not to use hormones.
  • Ongoing research efforts are focused on long-term safety and optimal dosing regimens for fezolinetant, underscoring a strong interest in non-hormonal treatment modalities within the medical community.
  • Overall, fezolinetant represents a potentially transformative option for menopausal women, reflecting a shift towards addressing the unmet need for effective non-hormonal therapies in this population.

Related articles

Research articles about Veozah (fezolinetant)

Veozah (fezolinetant)

The NK3 Receptor Antagonist ESN364 Suppresses Sex Hormones in Men and Women.

London, UK

2 hours ago

1 Received

  • The study tested the NK3 receptor antagonist, ESN364, to see how it affects hormone levels and the safety of this treatment in both healthy men and women.
  • Participants received varying doses through single and multiple administrations, with outcomes measuring levels of key hormones like LH, FSH, testosterone, estradiol, and progesterone, as well as physical side effects.
  • Results showed that ESN364 was safe and effectively lowered certain hormone levels, leading to delayed ovulation and altered menstrual cycles in women, though these effects were quickly reversible.

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Neurokinin 3 receptor antagonism decreases gonadotropin and testosterone secretion in healthy men.

London, UK

2 hours ago

1 Received

  • The study investigates the role of neurokinin B (NKB) and its receptor (NK3R) in regulating reproductive hormones in healthy men, highlighting their connection to hypogonadotrophic hypogonadism in patients with specific mutations.
  • Six men participated, receiving an NK3R antagonist for a week, while their levels of reproductive hormones including LH, FSH, and testosterone were monitored.
  • Results showed that NKB/NK3R is crucial for normal reproductive function, as blocking this pathway decreased hormone secretion, but kisspeptin administration continued to stimulate LH, indicating that NKB/NK3R operates upstream of kisspeptin in regulating hormone release.

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Scaffold hopping of fused piperidine-type NK3 receptor antagonists to reduce environmental impact.

London, UK

2 hours ago

1 Received

  • - Neurokinin-3 receptor (NK3R) is crucial for helping to release hormones in the hypothalamus-pituitary-gonadal (HPG) axis, which influences reproductive functions.
  • - Researchers created new NK3R antagonists, focusing on reducing environmental toxicity while designing various heterocyclic structures based on the triazolopiperazine framework.
  • - An isoxazolo[3,4-c]piperidine compound showed moderate effectiveness as an NK3R antagonist and had beneficial properties that allowed it to break down in the environment.

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Treatment of Menopausal Vasomotor Symptoms With Fezolinetant, a Neurokinin 3 Receptor Antagonist: A Phase 2a Trial.

London, UK

2 hours ago

1 Received

  • The study focuses on the effectiveness and safety of fezolinetant, an NK3R antagonist, in treating vasomotor symptoms (VMSs) experienced by menopausal women due to hormonal imbalances.
  • Conducted over 12 weeks in multiple Belgian centers, the double-blind randomized trial compared fezolinetant treatment to a placebo in participants aged 40 to 65 with moderate/severe VMSs.
  • Results demonstrated that fezolinetant significantly reduced the severity and frequency of VMSs and improved quality of life, with gastrointestinal disorders being the most common side effect noted.

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A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause.

London, UK

2 hours ago

1 Received

  • The study aimed to evaluate fezolinetant, a non-hormone treatment targeting neurokinin 3 receptors, for alleviating menopausal vasomotor symptoms (VMS) in women aged 40-65 with moderate to severe symptoms.
  • Participants were randomly assigned to different dosing regimens of fezolinetant or a placebo for 12 weeks, with the main outcomes being the frequency and severity of VMS episodes.
  • Results showed significant reductions in VMS frequency and severity for those taking fezolinetant compared to placebo, with a high percentage of participants achieving a 50% reduction in symptoms, and the treatment was generally well-tolerated.

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More promising news (mostly) on manipulating neurokinin B activity as a nonhormonal treatment of hot flashes.

London, UK

2 hours ago

1 Received

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Fezolinetant findings can fuel future instrumentation inquiries.

London, UK

2 hours ago

1 Received

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Effect of the neurokinin 3 receptor antagonist fezolinetant on patient-reported outcomes in postmenopausal women with vasomotor symptoms: results of a randomized, placebo-controlled, double-blind, dose-ranging study (VESTA).

London, UK

2 hours ago

1 Received

  • The phase 2b VESTA study found that oral fezolinetant significantly reduced the frequency and severity of menopausal vasomotor symptoms (VMS) compared to a placebo.
  • In a 12-week double-blind trial with 356 postmenopausal women, those taking various doses of fezolinetant showed better responder rates and improvements in patient-reported outcomes (PROs) related to quality of life.
  • The results indicated that fezolinetant yielded significantly greater improvements in measures like the Menopause-Specific Quality of Life questionnaire and Hot Flash-Related Daily Interference Scale, surpassing the minimally important differences (MIDs) at both 4 and 12 weeks.

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Fezolinetant in the treatment of vasomotor symptoms associated with menopause.

London, UK

2 hours ago

1 Received

  • International guidelines support the use of menopausal hormone therapy (HT) for women under 60 or within 10 years of menopause, but safety concerns about cancer and other risks have led to decreased usage.
  • There is a demand for effective non-hormonal therapies to alleviate menopausal vasomotor symptoms (VMS), such as hot flashes.
  • Fezolinetant, a neurokinin-3 receptor (NK3R) antagonist, is in advanced clinical development and has shown promising results in reducing VMS frequency and severity, providing a potential non-hormonal treatment option.

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Randomized Controlled Trial of Neurokinin 3 Receptor Antagonist Fezolinetant for Treatment of Polycystic Ovary Syndrome.

London, UK

2 hours ago

1 Received

  • Polycystic ovary syndrome (PCOS) is a common endocrine disorder that causes fertility issues primarily due to high androgen levels.
  • A study tested the effectiveness and safety of the NK3 receptor antagonist fezolinetant in reducing testosterone levels in women with PCOS.
  • Results showed that fezolinetant significantly lowered total testosterone and improved the LH-to-FSH ratio, indicating its potential as a treatment for PCOS-related hyperandrogenism, with no major safety concerns.

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Effects of neurokinin 3 receptor antagonist fezolinetant on hot flash-like symptoms in ovariectomized rats.

London, UK

2 hours ago

1 Received

  • * Fezolinetant, an NK3 receptor antagonist in phase 3 trials, showed promise in reducing these menopausal symptoms by lowering certain hormone levels and inhibiting neuronal activity in a study using ovariectomized rats.
  • * The research indicated that fezolinetant not only reduced hot flash-like symptoms but also helped control increased appetite and weight gain, supporting its potential as a treatment for menopause-related VMS.

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Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review.

London, UK

2 hours ago

1 Received

  • Hot flushes or flashes affect up to 97% of women during menopause, and while Hormone Replacement Therapy (HRT) can help, many women either can't or don't want to use it, creating a demand for effective non-hormonal treatments.
  • Recent research highlights neurokinin 3 receptor antagonists (NK3Ras) as a promising new option, potentially offering better results for managing hot flushes than the commonly used Serotonin Norepinephrine Reuptake Inhibitors (SNRIs).
  • Trials show NK3Ras significantly reduce hot flush frequency and severity more effectively than SNRIs, with NK3Ras also being better tolerated, although some safety concerns like elevated liver enzymes were

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Drugs for the treatment of postmenopausal symptoms: Hormonal and non-hormonal therapy.

London, UK

2 hours ago

1 Received

  • - Postmenopausal symptoms arise from a lack of estrogen, and treatments include hormonal therapy (HT) and non-hormonal options, but finding the best approach to balance benefits and risks is still uncertain.
  • - Hormonal therapy is recognized as the most effective treatment, especially when started soon after menopause, though careful consideration of individual risks for chronic diseases is necessary for personalized treatment plans.
  • - New potential treatments, like fezolinetant and vaginal lasers, show promise, but more research is needed for long-term safety and effectiveness; herbal remedies are also used but require further investigation into their side effects.

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Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study.

London, UK

2 hours ago

1 Received

  • * The SKYLIGHT 1 trial was a phase 3, double-blind, placebo-controlled study that involved 2,205 women aged 40-65 with moderate-to-severe hot flashes, comparing the effects of fezolinetant in two dosages against placebo over 12 weeks.
  • * Results showed the study was safely conducted and aimed to analyze changes in the frequency and severity of hot flashes, contributing valuable data on non-hormonal treatments for menopause symptoms.

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Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial.

London, UK

2 hours ago

1 Received

  • The study aimed to assess the safety and impact of fezolinetant on endometrial health in postmenopausal women experiencing hot flashes, testing it over 52 weeks with a randomized control design.
  • A total of 1,830 participants were involved, analyzing three groups: a placebo, and two fezolinetant dosages (30 mg and 45 mg), with the primary focus on adverse events and endometrial conditions.
  • Results showed similar rates of adverse events across all groups, with very few cases of endometrial hyperplasia and malignancy, suggesting that fezolinetant was generally safe for long-term use in this population.

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The effectiveness and value of fezolinetant for moderate-to-severe vasomotor symptoms associated with menopause: A summary from the Institute for Clinical and Economic Review's Midwest Public Advisory Council.

London, UK

2 hours ago

1 Received

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Fezolinetant (Veozah) for menopausal vasomotor symptoms.

London, UK

2 hours ago

1 Received

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Neurokinin 1/3 receptor antagonists for menopausal women: A current systematic review and insights into the investigational non-hormonal therapy.

London, UK

2 hours ago

1 Received

  • * A systematic review analyzed data from six databases and included 10 studies with nearly 2,000 women, focusing on the effects of NK1/3 receptor antagonists.
  • * The findings indicate that these antagonists may reduce the frequency and severity of hot flashes, but more clinical trials are needed to confirm their safety and effectiveness.

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The 2023 nonhormone therapy position statement of The North American Menopause Society.

London, UK

2 hours ago

1 Received

  • This text updates the 2015 position statement on nonhormonal treatments for menopause-related vasomotor symptoms by reviewing recent literature on various treatment options, organized into five categories.
  • A panel of experts evaluated evidence and recommended several nonhormonal therapies like cognitive-behavioral therapy, gabapentin, and fezolinetant, while deeming others like herbal supplements and certain relaxation techniques not recommended due to limited evidence.
  • The conclusion emphasizes that while there are effective nonhormonal options, hormone therapy is still the most effective treatment for managing vasomotor symptoms in menopausal women.

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