Elinzanetant for Hot Flashes

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Bayer

Disqualifiers: Seizures, Liver enzyme elevation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 7 days per period

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the body absorbs and processes a new drug, elinzanetant, when administered in various forms. It aims to treat hot flashes by testing different delivery methods to determine the most effective one. Participants will receive different sequences of the treatment to compare results. Women aged 18 to 65 who are healthy and meet specific health criteria are suitable candidates for this study. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that elinzanetant is generally safe for people, with studies indicating a strong safety record. In a year-long study, most participants experienced only a few side effects. Importantly, this study raised no new concerns about liver health. As a result, many people can take elinzanetant without problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Elinzanetant for treating hot flashes because it offers a new approach compared to standard hormone replacement therapies. Unlike traditional treatments that primarily focus on estrogen, Elinzanetant targets neurokinin receptors, which are implicated in the regulation of body temperature. This unique mechanism may provide relief from hot flashes without the hormone-related side effects, making it a promising option for those who cannot or prefer not to use hormone-based therapies. Additionally, the potential for fewer side effects could improve the quality of life for many women experiencing this common menopausal symptom.

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

Research has shown that elinzanetant reduces hot flashes and night sweats. In one study, participants experienced a more than 73% decrease in the frequency and severity of these symptoms. Over a year, elinzanetant proved effective and safe for a wide range of people. Another study found that this treatment consistently improved sleep quality while reducing hot flashes. These promising results suggest that elinzanetant could be a good option for managing menopause-related symptoms like hot flashes. Participants in this trial will receive elinzanetant in different sequences to further evaluate its effectiveness and safety. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy female participants who experience hot flashes. They must pass a health screening and commit to a study duration of about 10-12 weeks, including multiple visits and overnight stays in the study ward.

Inclusion Criteria

Participant is overtly healthy as determined by the investigator

Signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

I am a woman aged 18 to 65 and ready to consent.

Exclusion Criteria

Febrile illness within 2 weeks before the start of the first study intervention

Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin, or gamma-glutamyl transferase (GGT) > 1.2 x upper limit of normal

I have had seizures that affected my health significantly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (ambulatory)

Treatment

Participants receive single and multiple doses of elinzanetant in different formulations, with pharmacokinetic profiling

7 days per period

Inpatient stay from Day -1 to Day 9

Washout

Participants undergo a washout period between treatment periods

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elinzanetant

Trial Overview The study tests the bioavailability (how well the body absorbs) of elinzanetant in new oral forms (treatments B and C) against an existing soft gel capsule form (treatment A). It involves fasting, standardized meals, blood sampling for pharmacokinetic profiles, and repeated doses over several days.

How Is the Trial Designed?

Group I: Sequence 6 Experimental Treatment 3 Interventions

Treatments are administered in sequence of B-A-C

Group II: Sequence 5 Experimental Treatment 3 Interventions

Treatments are administered in sequence of B-C-A

Group III: Sequence 4 Experimental Treatment 3 Interventions

Treatments are administered in sequence of C-B-A

Group IV: Sequence 3 Experimental Treatment 3 Interventions

Treatments are administered in sequence of C-A-B

Group V: Sequence 2 Experimental Treatment 3 Interventions

Treatments are administered in sequence of A-C-B

Group VI: Sequence 1 Experimental Treatment 3 Interventions

Treatments are administered in sequence of A-B-C

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2838538

Elinzanetant for the Treatment of Vasomotor Symptoms ... In this randomized clinical trial, elinzanetant demonstrated a favorable efficacy and safety profile over 52 weeks in a broad study population ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40920404/

Elinzanetant for the Treatment of Vasomotor Symptoms ... The primary outcome was mean change from baseline to week 12 in the frequency of daily moderate to severe VMS, menopause-related quality of life.

3. newsroom.uvahealth.com newsroom.uvahealth.com/2025/09/16/drug-reduces-hot-flashes-by-73-trial-finds/

Drug Reduces Hot Flashes by 73%, Trial Finds Elinzanetant recipients saw a more than 73% reduction in the frequency and severity of “vasomotor symptoms” – hot flashes and night sweats – by ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05099159

NCT05099159 | A Study to Learn More About How Well ... In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A ...

5. ajmc.com ajmc.com/view/elinzanetant-shows-consistent-efficacy-safety-and-sleep-benefits-across-studies

Elinzanetant Shows Consistent Efficacy, Safety, and Sleep ... Elinzanetant 120 mg consistently reduced daily VMS frequency and severity and improved sleep quality from baseline to week 12, with greater mean ...

6. ajmc.com ajmc.com/view/elinzanetant-shows-strong-52-week-safety-for-vasomotor-symptoms-james-simon-md

Elinzanetant Shows Strong 52-Week Safety for Vasomotor ... US safety data show that elinzanetant caused few adverse events and no new liver-related concerns in women, James Simon, MD, explains.

7. bayer.com bayer.com/media/en-us/data-from-phase-iii-study-oasis-3-support-efficacy-and-long-term-safety-of-investigational-compound-elinzanetant-in-the-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/

Data from Phase III study OASIS 3 support efficacy and ... Results from the Phase III OASIS 3 study further support efficacy data and sustained safety data of elinzanetant over 52 weeks.

8. contemporaryobgyn.net contemporaryobgyn.net/view/elinzanetant-demonstrates-favorable-safety-profile-in-menopausal-women-with-james-a-simon-md

Elinzanetant demonstrates favorable safety profile in ... Elinzanetant shows a strong safety profile with no liver toxicity and minimal side effects in menopausal women with vasomotor symptoms.