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Elinzanetant

Elinzanetant is an investigational drug being studied for the treatment of vasomotor symptoms (hot flashes) associated with menopause. This article summarizes key information from multiple clinical trials evaluating the efficacy, safety, and pharmacokinetics of elinzanetant in postmenopausal women and other populations experiencing hormone-related hot flashes.

Table of Contents

What is Elinzanetant?

Elinzanetant, also known as BAY3427080 or NT-814, is a new medication currently being developed to treat symptoms associated with hormonal changes, particularly those experienced during menopause[1]. It is not yet approved for use by regulatory agencies and is still undergoing clinical trials to evaluate its effectiveness and safety.

How Does Elinzanetant Work?

Elinzanetant works by blocking a protein called neurokinin from sending signals to other parts of the body. Researchers believe that this protein plays a role in triggering hot flashes and other menopausal symptoms[1]. By inhibiting neurokinin, elinzanetant aims to reduce the frequency and severity of these symptoms, potentially improving the quality of life for women experiencing menopause.

What Conditions Does Elinzanetant Treat?

Elinzanetant is primarily being studied for the treatment of:

  • Vasomotor symptoms (VMS) associated with menopause: These are commonly known as hot flashes and night sweats. They can significantly impact a woman’s quality of life during and after menopause[2].
  • Sleep disturbances related to menopause: Many women experience difficulty sleeping due to night sweats and other menopausal symptoms[3].
  • VMS caused by anti-cancer therapy in women with hormone-receptor positive breast cancer: Some breast cancer treatments can induce menopausal symptoms, and elinzanetant is being studied as a potential treatment for these side effects[4].

Clinical Trials and Research

Several clinical trials are currently underway to evaluate elinzanetant’s effectiveness and safety:

  • OASIS-2 Study: This is a 26-week study comparing elinzanetant to a placebo in postmenopausal women with hot flashes[1].
  • 52-Week Study: A longer-term study evaluating the efficacy and safety of elinzanetant over 52 weeks in postmenopausal women[2].
  • Breast Cancer Study: A study focused on women with hormone-receptor positive breast cancer who experience hot flashes due to anti-cancer therapy[4].
  • Sleep Disturbance Study: A study specifically looking at how elinzanetant affects sleep disturbances associated with menopause[3].

These trials are measuring various outcomes, including changes in the frequency and severity of hot flashes, improvements in sleep quality, and overall quality of life for women experiencing menopausal symptoms.

Dosage and Administration

In most clinical trials, elinzanetant is being tested as an oral medication, typically taken as capsules once daily. The most common dosage being studied is 120 mg per day[1]. However, it’s important to note that the optimal dosage may change based on the results of ongoing research.

Safety and Side Effects

As elinzanetant is still in the research phase, comprehensive information about its safety profile and potential side effects is not yet available. The ongoing clinical trials are carefully monitoring for any adverse events (unexpected medical problems) that participants may experience during the studies[1].

Researchers are paying close attention to how elinzanetant interacts with other medications. For example, studies are being conducted to understand how elinzanetant might affect the levels of other drugs in the body, such as rosuvastatin (a cholesterol-lowering medication)[5].

Elinzanetant in Special Populations

Researchers are also studying how elinzanetant works in specific groups of people:

  • Women with kidney problems: A study is looking at how elinzanetant is processed by the body in women with reduced kidney function compared to those with normal kidney function[6].
  • Chinese women: A specific study is being conducted to understand how elinzanetant works in healthy Chinese women aged 40 to 65 years[7].

These studies will help determine if dosage adjustments or special considerations are needed for different groups of patients.

Aspect Details
Drug Name Elinzanetant (BAY3427080)
Primary Indication Treatment of vasomotor symptoms (hot flashes) associated with menopause
Mechanism of Action Blocks neurokinin receptors to reduce hot flashes
Administration Oral capsules, typically 120 mg once daily
Key Study Populations Postmenopausal women, breast cancer patients on endocrine therapy
Primary Outcomes Change in frequency and severity of moderate to severe hot flashes
Secondary Outcomes Sleep quality, quality of life, safety profile
Study Durations Range from 12 to 52 weeks of treatment
Notable Features Non-hormonal treatment option, potential for use in breast cancer patients

FAQ

  • What is elinzanetant and how does it work? Elinzanetant is an investigational drug developed to treat hot flashes caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in triggering hot flashes.
  • What are the main goals of the clinical trials studying elinzanetant? The main goals are to evaluate how well elinzanetant reduces the frequency and severity of hot flashes compared to placebo, assess its safety profile, and understand how the drug moves through the body (pharmacokinetics) in different populations.
  • Who is being included in these clinical trials? The trials are primarily including postmenopausal women experiencing hot flashes. Some studies also include women with breast cancer on anti-cancer therapy, as well as healthy volunteers to study the drug's properties.
  • How is elinzanetant administered in these trials? Elinzanetant is typically administered as oral capsules taken once daily. The dosage being studied in most trials is 120 mg per day.
  • What are some of the key outcomes being measured? Key outcomes include changes in the frequency and severity of hot flashes, effects on sleep quality, impact on quality of life, and the occurrence of any side effects or adverse events during treatment with elinzanetant.

Ongoing Clinical Trials on Elinzanetant

  • Study on How Elinzanetant Affects Dabigatran Etexilate in Healthy Volunteers with Vasomotor Symptoms

    Not recruiting

    1 1 1
    Investigated drugs:
    Germany

  • Study on Elinzanetant for Treating Hot Flashes in Women with or at High Risk for Hormone-Receptor Positive Breast Cancer

    Not recruiting

    1 1
    Investigated drugs:
    Austria Belgium Finland France Germany Hungary +6

  • Study on Elinzanetant for Treating Sleep Disturbances in Menopausal Women

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Germany The Netherlands Poland +1

Glossary

  • Vasomotor symptoms (VMS): Physical symptoms such as hot flashes and night sweats that are caused by hormonal changes, particularly during menopause.
  • Hot flashes: Sudden feelings of warmth, usually most intense over the face, neck and chest, often accompanied by sweating and rapid heartbeat.
  • Menopause: The time in a woman's life when menstrual periods permanently stop, marking the end of the reproductive years.
  • Placebo: A substance that has no active ingredients and is used as a control in clinical trials to test the effectiveness of treatments.
  • Pharmacokinetics: The study of how a drug moves into, through, and out of the body; includes absorption, distribution, metabolism, and excretion.
  • Neurokinin: A protein in the body that elinzanetant is designed to block, which is thought to be involved in triggering hot flashes.
  • Efficacy: How well a treatment works to produce a desired effect under ideal circumstances.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment or procedure.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • Hormone-receptor positive breast cancer: A type of breast cancer that has receptors for estrogen or progesterone, making it responsive to hormonal therapies.

References

  1. https://clinicaltrials.gov/study/NCT05099159
  2. https://clinicaltrials.gov/study/NCT05030584
  3. https://clinicaltrials.gov/study/NCT06112756
  4. https://clinicaltrials.eu/trial/study-on-elinzanetant-for-treating-hot-flashes-in-women-with-or-at-high-risk-for-hormone-receptor-positive-breast-cancer/
  5. https://clinicaltrials.gov/study/NCT04889287
  6. https://clinicaltrials.gov/study/NCT05071729
  7. https://clinicaltrials.gov/study/NCT05381142