(22423 NIRVANA) A randomized, parallel-group treatment, Phase 2, double-blind pilot study to investigate the efficacy and safety of elinzanetant compared with placebo for treatment of sleep disturbances associated with menopause - 22423

Start Date26 Mar 2024

Sponsor / Collaborator

Bayer Consumer Care AG

[+1]

NCT06219902

/ CompletedPhase 1

A Randomized, Double-blind, Placebo- and Active-controlled, 4-period, Crossover Study to Investigate Effects of Elinzanetant on Simulated Driving Performance and Cognitive Function in Healthy Women

Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes.
Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.
The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.
Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.
The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.
For this, researchers will study participants' ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).
In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.
Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.
Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.
This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):
* dose A of elinzanetant and a zopiclone placebo
* dose B of elinzanetant and a zopiclone placebo
* zopiclone 7.5 milligrams (mg) and elinzanetant placebo
* elinzanetant placebo and zopiclone placebo
Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.
Participants will visit the study site:
* once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
* once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
* once, 2 to 3 days after their last treatment so the study doctors and their team can check on their health
During the study, the doctors and their study team will:
* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* check the participants' ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
* check the level of the study drugs in participants' blood
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment or not.

Start Date08 Jan 2024

Sponsor / Collaborator

Bayer AG

NCT06112756

/ CompletedPhase 2

A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause.
Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.
The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.
The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.
For this, the researchers will analyze
* change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment
* change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment
* change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.
The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.
Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.
During the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check vital signs
* do sleep tests
* use an electronic hand-held device to record sleep quality and hot flashes at home
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date08 Nov 2023

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Elinzanetant

100 Translational Medicine associated with Elinzanetant

100 Patents (Medical) associated with Elinzanetant

Literatures (Medical) associated with Elinzanetant

01 Nov 2025·DRUGS

Advances in Pharmacotherapy for Menopausal Vasomotor Symptoms

Review

Author: Young Moss, Stephanie ; Simon, James A ; Lee, Angie

Vasomotor symptoms (VMS) are considered the cardinal symptoms of menopause, affecting up to 80% of American women at some point during the menopausal transition. VMS, particularly if they are moderate to severe, frequent, or cause sleep disturbances, can have a negative impact on a woman's quality of life, physical and mental health, and professional life. Furthermore, VMS have been associated with negative health outcomes, including an increased risk of coronary heart disease and cognitive impairment. Menopausal hormonal therapy (MHT) is supported by level 1 evidence and can address many of the negative impacts associated with menopause, including VMS. However, not all women can take MHT (owing to having contraindications to their use) or choose not to take MHT. In addition to MHT, non-hormonal therapy options, which include neurokinin (NK)-targeted therapies, are also available. Fezolinetant (NK3 receptor antagonist) and the newly approved elinzanetant (NK1 and NK3 receptor antagonist) are non-hormonal treatment options approved for the treatment of VMS associated with menopause. These approvals expand the treatment options for women. A number of investigational agents are currently in phase 2 trials for potential future use for VMS; these include Q-122, PhytoSERM, NOE-115, GS1-144, and HS-10384. In this review, we highlight the recent advancements in our understanding of the pathophysiology of VMS and consider the current, new, and investigational treatment options for the treatment of VMS.

01 Oct 2025·OBSTETRICS AND GYNECOLOGY

Novel Pharmacotherapies for Menopausal Symptoms

Review

Author: Pal, Lubna ; Liao, Caiyun

Menopausal hormone therapy (HT) is highly effective against vasomotor symptoms (VMS). When HT is contraindicated, ineffective, or unacceptable, alternatives have included antidepressants, antiseizure, and antihypertensive formulations. Novel pharmacologic treatments for VMS have emerged in recent decades, some of which are already approved by the U.S. Food and Drug Administration (FDA) (eg, fezolinetant, a neurokinin 3B antagonist), and others are poised to seek FDA approval (eg, elinzanetant, a dual neurokinin 1B and 3B antagonist, and estetrol, a natural estradiol derivative that is unique to the pregnant state). Oxybutynin was shown to be effective for VMS and could provide additional benefits against overactive bladder, but long-term safety data are needed before wider utilization can be recommended.

01 Oct 2025·CURRENT OPINION IN OBSTETRICS & GYNECOLOGY

Nonhormonal treatments for vasomotor symptoms

Review

Author: Santoro, Nanette ; Zalles, Laura

Purpose of the review:

Vasomotor symptoms or hot flashes are reported by 80% of women and have a median duration of 7 years. About 25–30% of women have severe enough symptoms that activities of daily living and workplace productivity are compromised. Although hormone therapy is the ‘gold standard’ for hot flash treatment, many women are unable or unwilling to use it.

Recent findings:

A number of nonhormone treatments for hot flashes are supported by medical evidence, but only two (paroxetine mesylate and fezolinetant) are currently Food and Drug Administration approved. Selective serotonin reuptake inhibitors and selective serotonin reuptake inhibitor–norepinephrine reuptake inhibitors, gabapentin, oxybutynin, clonidine, and fezolinetant are described. The new class of neurokinin-3 receptor antagonists includes both fezolinetant and elinzanetant and acts directly on the hypothalamic neurons that control body temperature regulation. These latter agents have an efficacy profile that approaches that of hormone therapy and lack the off-target side effects seen with other nonhormonal treatments.

Summary:

Women who cannot use or wish to avoid hormones have a number of nonhormonal options to choose from to treat hot flashes. New science elucidating the biology of hot flashes holds great promise for highly effective treatments that do not have off-target effects.

103

News (Medical) associated with Elinzanetant

05 Nov 2025

·www.pharmaceutical-technology.com

Deeply embedded, agentic AI constitutes the “next wave” of tech

At the 2025 Veeva Commercial Summit, Bayer’s Stefan Schmidt and Veeva’s VP of European commercial strategy, Philipp Luik, discussed the current and future potential of agentic AI. Image credit: Annabel Kartal-Allen, GlobalData. Artificial intelligence (AI) has become a key buzzword in the pharmaceutical industry, with most, if not all, companies looking to incorporate the technology into their workflow across R&D, data management and commercial operations. At the 2025 Veeva Commercial Summit , held at the Madrid Marriot Auditorium from 5-6 November, a central theme was not just the use of AI, but its comprehensive integration into day-to-day operations. This includes the emerging movement toward agentic AI, which is designed to perform tasks with minimal human intervention. In conversation with Pharmaceutical Technology , Stefan Schmidt, digital capability lead of field engagement at Bayer, noted that, while agentic AI holds great promise, the company is not yet able to use it to execute administrative tasks. To achieve this, Schmidt is looking to focus on augmented AI before employing next-generation agentic tools, as the latter requires full user trust, as well as confirmation that the technology is “doing the right thing and gathering suitable information when used autonomously”. “I believe we should not try to achieve everything at once. Instead, we should follow this journey in steps – starting smaller with augmented and moving towards agentic with time,” Schmidt commented, adding that this could take Bayer as little as a couple of months. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence In the commercial setting, Schmidt mentioned that Bayer has already created an AI-powered coaching agent internally. This tool is designed to be an interactive educational tool for the newly approved, non-hormonal menopause drug, Lynkuet (elinzanetant), and works by pulling information from proof documents so patients can ask specific questions about the drug. Moving forward, the German pharma’s future vision for its AI capabilities centres around creating a “one-stop shop for the field rep,” which allows the user to execute all relevant tasks relating to customer relationship management (CRM). “This could include training, governance and expense topics; we want to create something that can really support our field users,” Schmidt stated. Driving productivity with agentic AI Schmidt’s sentiments on agentic AI were echoed by Veeva’s VP of European commercial strategy, Philipp Luik, in a keynote session from the first day of the conference. This follows Veeva’s recent bid to integrate the technology into its core offerings. During the talk, Luik noted that the “deep embedding” of AI is necessary for its long-term success in the field. “As you enter the next wave of AI, the focus must change to achieve vertical percent productivity gains,” he commented. In the session, Luik noted that the layering of AI is no longer enough, meaning the technology should now be comprehensively integrated into a company’s day-to-day activities, while “respecting the same compliance tools and access control”. He also mentioned that AI technologies should be “future-proof”, meaning they are able to keep up with the “exponential” evolution of the space. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

27 Oct 2025

·www.biospace.com

Bayer Gets FDA Nod for Novel Drug to Treat Hot Flashes

iStock, Detlef Voigt Lynkuet is the first FDA-approved therapy that blocks both the neurokinin 1 and neurokinin 3 receptors to treat hot flashes. The FDA signed off on Bayer’s oral therapy elinzanetant for the treatment of moderate to severe hot flashes in menopausal women. The drug will be available in the U.S. in November under the brand name Lynkuet, according to an announcement Friday. Data from the Phase III OASIS development program supported the FDA’s decision. In August 2024, Bayer released data from OASIS 1 and OASIS 2 , touting significant symptom relief in patients treated with Lynkuet. OASIS 1 showed a 55.9% reduction in vasomotor symptoms (VMS) after 4 weeks and 65.2% at week 12, while OASIS 2 detected a 57.9% and 67% VMS improvement at weeks 4 and 12, respectively. Both studies also showed that patients taking placebo who later switched to Lynkuet likewise experienced VMS reductions. Bayer followed these data up with another readout in September 2024, this time from the OASIS 3 study , which followed patients for 52 weeks. Results pointed to Lynkuet’s long-term safety and efficacy, with the drug showing a favorable safety pro one year of follow-up. Lynkuet’s label flags some risks, including daytime impairments and sleepiness, as well as potential pregnancy loss. Lynkuet should not be given to pregnant women. Efficacy data from OASIS 3 also supported OASIS 1 and OASIS 2’s findings, eliciting a significant 12-week reduction in VMS . Lynkuet targets neurokinin 1 and neurokinin 3 receptors on neurons, blocking the mechanism of heat generation during hot flashes, the first such drug to target this pathway, according to Bayer. The drug is taken as a gel capsule once daily before sleep. Aside from these three studies, Bayer also tested Lynkuet in the Phase III OASIS 4 study, which it ran outside the U.S. and focused on women with HR-positive breast cancer on endocrine therapy. Results, released in June this year, likewise demonstrated a significant decrease in VMS at week 4 versus placebo, an effect the drug was able to sustain through 12 weeks.

Clinical ResultPhase 3Drug Approval

27 Oct 2025

·www.biopharmadive.com

Bayer receives FDA approval for non-hormonal menopause therapy

The Food and Drug Administration late Friday approved a new, non-hormonal treatment for postmenopausal women who experience vasomotor symptoms, also known as hot flashes.The drug, called Lynkuet and developed by Bayer, was cleared to treat moderate severe hot flashes due to menopause. Approval was supported by three late-stage trials that enrolled thousands of women. Data showed treatment reduced both the frequency and severity of hot flashes.There is a need for more individualized approaches to menopause care, and Lynkuetaddresses a significant gap in treatment options, said Christine Roth, Bayers executive vice president of global product strategy and commercialization, in a statement.Vasomotor symptoms typically occur during and after menopause, a transition when a womans menstrual cycle stops. The drop in estrogen levels thats associated with menopauseleads to these symptoms, which range in severity and can be life-disrupting,sometimes for years.Menopause hormone therapy, also known as hormone replacement therapy, is one treatment option. However, not everyone is a good candidate for hormonal therapy, while others might opt out due to health risks.One other non-hormonal treatment is on the market for vasomotor symptoms: Astellas Pharmas Veozah. The drug was approved in 2023 but has struggledcommercially due to lower-than-expected demand and complications with reimbursement. Most recently, the FDA added a black box warningfor possible liver damage on the drugs labeling.Bayers drug works similarly to Veozah by blocking what are known as neurokinin receptors. Lynkuet targets two receptors, NK1 and NK3, which help regulate body temperature, while Veozah targets just NK3.We think that there's a benefit from targeting two receptors, said JoAnn Pinkerton, a lead investigator in a clinical trial testing Lynkuet, and a professor of obstetrics and gynecology at the University of Virginia Health System.We saw a very rapid reduction in hot flashes and night sweats similar to [Veozah], and an improvement in the severity of the hot flashes, as well as an improvement in health-related quality of life and sleep, Pinkerton said in a recent interview.The approval of Veozah and, now, Lynkuet, is spotlighting an area thats receiving heightened attention among investors and biotech companiesand greater awareness more broadly. Menopause is having a moment with all of the excitement of new therapies. And many women in the workforce are recognizing that perimenopause and menopause are having an effect on their ability to function at a high level, Pinkerton said.One example of that growing attention was an FDA panel discussion earlier this year on hormonal therapies for menopause. At that meeting, a panel that included Pinkerton called for the removal of warning labels associated with treatment.Though the FDA hasnt issued further guidance since,Pinkerton hopes the meeting, and surge in research interest, are signs of things to come.I think [the key] is that women have to support each other and try to move this field forward in this country and other countries, she said.Lynkuet is expected to be available in the U.S. in November.Wholesale acquisition cost of Lynkuet is $625 for a 30-day supply. Pricing will vary based on insurance. Bayer has also partnered with digital pharmacy BlinkRx to provide access to the drug at a lower cost. '

Drug ApprovalAcquisition

100 Deals associated with Elinzanetant

External Link

KEGG	Wiki	ATC	Drug Bank
-	Elinzanetant	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Vasomotor symptom	United States	Bayer HealthCare Pharmaceuticals, Inc.	24 Oct 2025
Hot Flashes	Canada	Bayer, Inc.	01 Jul 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	Phase 2	United States	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Austria	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Belgium	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Czechia	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Germany	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Poland	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Spain	Bayer AG	08 Nov 2023
Dyssomnias	Phase 2	United States	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	Canada	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	Canada	Bayer AG	20 Nov 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05587296 (OASIS 4 \| OASIS-4, CTgov)	Phase 3	Hot Flashes \| Vasomotor symptom	474	Elinzanetant (BAY3427080)	nsxrrowafe(rqwjuvzpco) = lyyvmzlofl ssqwrzloqa (lhlrldhoky, 6.89) View more	-	29 Oct 2025
NCT05099159 \| NCT05042362 (OASIS 1, FDA_CDER) Manual	Phase 3	Vasomotor symptom	796	LYNKUET 120 mg (OASIS 1)	wbsuqsyhux(ygllvgjcrl) = pjnpbjldlb blrzvlawyi (otxktwatba, 0.43) View more	Positive	24 Oct 2025
				Placebo (OASIS 1)	wbsuqsyhux(ygllvgjcrl) = phkdeyaghp blrzvlawyi (otxktwatba, 0.43) View more
NCT05030584 (OASIS-3, Pubmed \| JAMA Intern Med)	Phase 3	Vasomotor symptom	628	Elinzanetant 120 mg	utvrkeypvb(nzvmeeznlu) = numerical advantages for elinzanetant vs placebo for improving VMS frequency and severity erbpvkcspw (oocpfmjfml ) View more	Positive	08 Sep 2025
				Placebo
NCT05587296 (OASIS 4, ASCO2025) Manual	Phase 3	Vasomotor symptom \| Hormone receptor positive breast cancer Adjuvant	-	Elinzanetant 120 mg	ixgduwwomd(tnqpzugewk) = quhrvczthg einaqkrgjl (degkyaivgm, 1.1) View more	Positive	30 May 2025
				Placebo	ixgduwwomd(tnqpzugewk) = hfatpecpfr einaqkrgjl (degkyaivgm, 1.2) View more
NCT05030584 (OASIS 4, PipelineReview) Manual	Phase 3	Vasomotor symptom	474	elinzanetant	bkfdfaxizu(pgusifxakf) = Elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. wdnlfbsenv (wttvojwsey ) Met View more	Positive	09 Jan 2025
				placebo
NCT05099159 \| NCT05042362 (OASIS 2 \| OASIS 1, Pubmed \| JAMA)	Phase 3	Vasomotor symptom	-	Elinzanetant 120 mg	bwbbgjzzkd(ayrblbrvvn) = skzubkgvub nwqjfinbjg (ucuxzvqkzc, 6.6)	Positive	22 Oct 2024
				Placebo	bwbbgjzzkd(ayrblbrvvn) = rockvbgouy nwqjfinbjg (ucuxzvqkzc, 13.9)
NCT05030584 (OASIS 3, NEWS 1 \| NEWS 2) Manual	Phase 3	Vasomotor symptom \| Hot Flashes	-	Elinzanetant	dbspkpxabm(illldlxwxq) = qyvcazbacv ciwbfcjkhl (odlfkifbug ) Met	Positive	10 Sep 2024
				Placebo	dbspkpxabm(illldlxwxq) = xpekqpuwki ciwbfcjkhl (odlfkifbug ) Met
NCT05042362 (OASIS-1, Biospace) Manual	Phase 3	Hot Flashes	396	Elinzanetant	quyjqrvsvs(afzxoronll) = The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. johlcdklwv (hubhkwurqj )	Positive	16 May 2024
NCT05099159 (OASIS-2, Biospace) Manual	Phase 3	Hot Flashes	400	Elinzanetant	jmtysjknfh(ewxasauluf) = The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. njgybdyjmi (pmtqwodpln )	Positive	16 May 2024
NCT05099159 \| NCT05042362 (OASIS 2, PipelineReview \| Company_Website) Manual	Phase 3	Vasomotor symptom	400	elinzanetant	mnzkfltzui(wiftwcauqf) = demonstrating statistically significant reductions gzgnoqlkjj (roycdnmbzm ) Met View more	Positive	08 Jan 2024
				Placebo

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