(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

21 Aug 2025·NEW ENGLAND JOURNAL OF MEDICINE

Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer

Article

Author: Haberland, Claudia ; Cardoso, Fatima ; Caetano, Cecilia ; Zuurman, Lineke ; Parke, Susanne ; Haseli-Mashhadi, Nazanin ; Panay, Nick ; Laapas, Kaisa ; Briggs, Paula ; Francuski, Maja ; Brennan, Donal J. ; Block, Michael ; Seitz, Christian ; Donders, Gilbert

BACKGROUND:

Women receiving endocrine therapy for hormone receptor (HR)-positive breast cancer or its prevention among those at high risk for breast cancer commonly have vasomotor symptoms. Data are lacking on the effects of elinzanetant, a neurokinin-targeted therapy shown to be effective in treating vasomotor symptoms, in this population.

METHODS:

We performed a phase 3 trial involving women 18 to 70 years of age with moderate-to-severe vasomotor symptoms associated with endocrine therapy for HR-positive breast cancer or its prevention. Women were randomly assigned in a 2:1 ratio to receive once-daily elinzanetant at a dose of 120 mg for 52 weeks or once-daily placebo for 12 weeks followed by once-daily elinzanetant at a dose of 120 mg for 40 weeks. The primary end points were the change in the mean daily frequency of moderate-to-severe vasomotor symptoms from baseline to week 4 and to week 12.

RESULTS:

A total of 316 participants were assigned to the elinzanetant group and 158 to the placebo-elinzanetant group. At baseline, the mean daily frequency of moderate-to-severe vasomotor symptoms was 11.4 episodes (95% confidence interval [CI], 10.7 to 12.2) in the elinzanetant group and 11.5 episodes (95% CI, 10.5 to 12.5) in the placebo-elinzanetant group. At week 4, the mean change from baseline in the mean daily frequency of moderate-to-severe vasomotor symptoms was -6.5 episodes (95% CI, -7.2 to -5.8) among those who were receiving elinzanetant and -3.0 episodes (95% CI, -3.9 to -2.2) among those who were receiving placebo (least-squares mean difference, -3.5 episodes; 95% CI, -4.4 to -2.6; P<0.001). At week 12, the mean change was -7.8 episodes (95% CI, -8.5 to -7.1) among those receiving elinzanetant and -4.2 episodes (95% CI, -5.2 to -3.2) among those receiving placebo (least-squares mean difference, -3.4 episodes; 95% CI, -4.2 to -2.5; P<0.001). During weeks 1 through 12, a total of 220 participants (69.8%) receiving elinzanetant and 98 (62.0%) receiving placebo reported at least one adverse event that occurred while receiving elinzanetant or placebo, with the most common being headache, fatigue, and somnolence. Serious adverse events occurred during weeks 1 through 12 in 8 participants (2.5%) receiving elinzanetant and 1 participant (0.6%) receiving placebo.

CONCLUSIONS:

Elinzanetant led to a significantly lower frequency of vasomotor symptoms associated with endocrine therapy than placebo. (Funded by Bayer; OASIS-4 ClinicalTrials.gov number, NCT05587296.).

07 Aug 2025·OBSTETRICS AND GYNECOLOGY

Novel Pharmacotherapies for Menopausal Symptoms.

Article

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 Aug 2025·CURRENT OPINION IN OBSTETRICS & GYNECOLOGY

Novel nonhormonal treatments for vasomotor symptoms of menopause

Review

Author: Santoro, Nanette

Purpose of review:

Hot flashes are a prevalent and bothersome symptom associated with menopause. Beyond the fact that they cause discomfort, hot flashes are responsible for significant healthcare costs and lost productivity among midlife women. They may also be a harbinger for future disease risk. While hormone therapy is a mainstay of treatment, many women cannot or do not wish to take hormones to mitigate their hot flashes.

Recent findings:

The discovery of the linkage of the neurokinin (NK) receptor to hot flashes has resulted in a rapid bench-to-bedside development of a new class of compounds targeting the NK3 receptor and its related pathways. Fezolinetant is the first FDA-approved medication in this class, and elinzanetant is awaiting FDA approval. Both agents are effective against hot flashes and represent exciting new nonhormonal treatments that are free of untoward off-target effects. Both have demonstrated improvements in patient self-reported sleep outcomes.

Summary:

Targeting of the NK receptor in the hypothalamus has led to the availability of nonhormonal options for menopausal women suffering from hot flashes.

News (Medical) associated with Elinzanetant

28 Jul 2025

·www.fiercepharma.com

Another FDA mini-pause for Bayer’s menopause candidate?

Drug approval delays have become more common since the FDA lost 19% of its workforce in April due to federally mandated budget cuts. After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet drug approval deadlines. The latest example is its failure to rule on Bayer’s menopause treatment, elinzanetant.On Friday, the German company said in a release that the FDA needed additional time to review its new drug application for elinzanetant, extending the Prescription Drug User Fee Act (PDUFA) review period by up to 90 days.The FDA was expected to make its decision by Saturday on the application, which was filed in August 2024. The new PDUFA date is Oct. 26.Bayer added that the FDA did not “raise any concern regarding the general approvability” of elinzanetant. Earlier this month, regulators in the U.K. endorsed the treatment, which is known commercially as Lynkuet. Canada followed suit last week with a thumbs-up, while a review is ongoing by the European Union.“We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,” Yesmean Wahdan, M.D., Bayer’s head of medical affairs in North America, said in a statement. “We continue to work with the FDA to make this treatment available.”Analysts at Barclays wrote that the delay was a “small negative” for Bayer, which has tabbed peak sales for the treatment at 1 billion euros ($1.2 billion). The company will likely add more details during its second-quarter earnings presentation on Aug. 6.Over the past four months, the FDA has delayed its review of several drugs, but most decisions have still arrived relatively quickly. In May, the agency approved GSK’s Nucala for COPD less than two weeks after its original PDUFA date.In July, the FDA signed off on KalVista’s rare disease drug Ekertly three weeks after its original PDUFA date. And in April and May, it took an extra six weeks to convert Novavax’s COVID-19 vaccine from accelerated to full approval. In May, the FDA took an extra month to reject a rare-disease drug from Stealth BioTherapeutics, though that application has been through a series of regulatory challenges since the Massachusetts company first presented data in 2019.Last week, the FDA also delayed a decision on GSK’s multiple myeloma drug Blenrep by 90 days, which was voted down as an agent in two separate combinations by an FDA advisory committee earlier this month.As for Bayer, it is hoping to join Astellas as the second company with a hormone-free treatment for patients with moderate to severe hot flashes that accompany menopause. While Astellas’ Veozah was the first neurokinin 3 (NK-3) receptor antagonist approved for the indication, Lynkuet is the first dual-action neurokinin in the indication, targeting the NK-3 and NK-1 receptors. Astellas reported 2024 fiscal year sales of Veozah at 33.8 billion yen ($230 million), which came up short of its expectations. Astellas has projected fiscal 2025 sales at 50 billion yen ($340 million). The company's peak sales projection for the treatment, which carries a black box warning for potential liver damage, is $3.6 billion.Despite being from the same treatment class, Lynkuet has shown scant evidence of the side effects in three phase 3 trials.

Drug ApprovalPhase 3VaccineClinical ResultAccelerated Approval

25 Jul 2025

·firstwordpharma.com

FDA needs more time to review Bayer's hot flash drug

The FDA has extended its review of elinzanetant, Bayer's proposed hormone-free option to treat vasomotor symptoms (VMS) associated with menopause, delaying a decision on the drug by up to three months. The move comes as Bayer begins to make inroads outside the US, with recent approvals of the dual NK-1,3 receptor antagonist in the UK and Canada under the brand name Lynkuet.Bayer said the FDA has determined it needs more time to conduct a full review of the submission, including information provided to support the application, adding the agency did not cite any issues with the overall approvability of elinzanetant."We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval," said Yesmean Wahdan, head of medical affairs for Bayer's North American pharmaceutical unit. "We continue to work with the FDA to make this treatment available."The therapy is being positioned as a potential rival to Astellas' NK-3 receptor antagonist fezolinetant, cleared in 2023 by the FDA as Veozah and in Europe as Veoza. Expectations were high for the Japanese drugmaker's VMS treatment, but it underperformed at launch and a liver safety signal has hampered sales (see – Spotlight On: Astellas' liver tox pain with Veozah could be Bayer's gain in VMS and ViewPoints: With incoming rival on horizon, Astellas charts Veozah's voyage to remain market leader).The elinzanetant filing includes results from the Phase III OASIS 1 and 2 studies, which were published in JAMA last year and showed significant reductions in VMS frequency and severity over 12 weeks versus placebo. Additionally, over 80% of treated participants achieved a reduction in their VMS frequency of at least half by week 26.In the Phase III OASIS 3 long-term study, women taking elinzanetant demonstrated a sustained significant reduction in the frequency of moderate-to-severe VMS compared to placebo, with no signs of liver toxicity.

Phase 3Clinical ResultDrug Approval

25 Jul 2025

·www.biopharmadive.com

FDA delays approval decision for Bayer menopause therapy

The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the companys application.In a Friday statement, Bayer said the FDA did not raise any concerns around general approvability of the drug, called elinzanetant. Still, the agency extended its decision deadline by three months.With the consistent positive results from our clinical Phase III program assessing the efficacy and safety of elinzanetant, we remain confident about elinzanetants potential as a new treatment option for moderate to severe vasomotor symptoms associated with menopause, Christian Rommel, Bayers global head of research and development, said in a statement.Bayer submitted elinzanetant last August based on three large late-stage studies known as OASIS 1, 2 and 3. Data showed treatment reduced the severity and frequency of vasomotor symptoms, also known as hot flashes, in women given the drug versus those who received placebo.If approved, elinzanetant would join Astellas Pharmas Veozah on the market as a non-hormonal option for menopausal women.While hot flashes can also be treated with hormonal therapy, the FDA warns of an increased risk of cardiovascular events and cancers in some women. (A group of experts convened by FDA head Martin Makary this week called for the agency to modify hormone therapys warning labeling, arguing it unnecessarily limits use.)Elinzanetant works similarly to Veozah, targeting a receptor known as neurokinin 3, as well as another dubbed neurokinin 1. Both receptors are involved in regulating body temperature.Bayers drug could have a competitive edge over Veozah, however. Veozah has struggled to take off commercially, and the FDA recently added a black box warning to its labeling for the risk of liver injury. Bayer has not reported similar side effects from testing of its drug.The U.K. and Canada recently approved elinzanetant, which Bayer will sell under the brand name Lynkuet there.As we continue to work with the FDA during the ongoing review, we are fully committed to making elinzanetant available to women in the U.S. as soon as we receive FDA approval, Rommel said in a statement.The FDA has missed, or extended, its approval deadlines for several other drugs in recent months.In a recent analysis of FDA approval deadlines, analyst Brian Abrahams and his team at RBC Capital Markets found some potentially concerning signals of greater missed target dates. However, they noted thats it difficult to tell whether this stems from a more methodical approach or resource limitations at the agency, or from drug company missteps.Their analysis, Abrahams wrote, does suggest delay risk for drugmakers with decision deadlines in the second half of this year. '

Phase 3Drug ApprovalClinical ResultAccelerated Approval

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
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
Vasomotor symptom	NDA/BLA	Canada	Bayer, Inc.	01 Sep 2024
Dyssomnias	Phase 2	United States	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	United States	Bayer AG	20 Nov 2018
Dyssomnias	Phase 2	Canada	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	Canada	Bayer AG	20 Nov 2018
Dyssomnias	Phase 2	United Kingdom	Bayer AG	20 Nov 2018
Dyssomnias	Phase 2	United Kingdom	NeRRe Therapeutics Ltd.	20 Nov 2018
Schizophrenia	Phase 1	United Kingdom	GSK Plc	20 Oct 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05587296 (OASIS 4, ASCO2025) Manual	Phase 3	Vasomotor symptom \| Hormone receptor positive breast cancer Adjuvant	-	Elinzanetant 120 mg	orzlukajhu(gkrenmjgta) = qyeowyykkz xbacypddje (eljuumraze, 1.1) View more	Positive	30 May 2025
				Placebo	orzlukajhu(gkrenmjgta) = azcodqxiaz xbacypddje (eljuumraze, 1.2) View more
NCT05030584 (OASIS 4, PipelineReview) Manual	Phase 3	Vasomotor symptom	474	elinzanetant	rlwgajwwyv(dgreurkzgx) = 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. mbojsokaan (ceqmvcnxtn ) Met View more	Positive	09 Jan 2025
				placebo
NCT05099159 \| NCT05042362 (OASIS 2 \| OASIS 1, Pubmed \| JAMA)	Phase 3	Vasomotor symptom	-	Elinzanetant 120 mg	ixlfqfygpj(oqxucpkynj) = dntmuuioip ojblugrqaq (icomkqjdag, 6.6)	Positive	22 Oct 2024
				Placebo	ixlfqfygpj(oqxucpkynj) = kmzkvnotvu ojblugrqaq (icomkqjdag, 13.9)
NCT05030584 (OASIS 3, NEWS 1 \| NEWS 2) Manual	Phase 3	Vasomotor symptom \| Hot Flashes	-	Elinzanetant	ctgyrcuxiu(zhjwycybxh) = brbaqosgoc okhvmfxigh (eujendlesk ) Met	Positive	10 Sep 2024
				Placebo	ctgyrcuxiu(zhjwycybxh) = gjbynxiewg okhvmfxigh (eujendlesk ) Met
NCT05042362 (OASIS-1, Biospace) Manual	Phase 3	Hot Flashes	396	Elinzanetant	eloozxexgn(grcbnbdhir) = 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. flxcmxjrrl (blxnqaaknq )	Positive	16 May 2024
NCT05099159 (OASIS-2, Biospace) Manual	Phase 3	Hot Flashes	400	Elinzanetant	ardiopglrb(nviekfnzla) = 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. eursedurjp (doafbxvloj )	Positive	16 May 2024
NCT05099159 \| NCT05042362 (OASIS 2, PipelineReview \| Company_Website) Manual	Phase 3	Vasomotor symptom	400	elinzanetant	rktbvtilqg(ftuqewcnlz) = demonstrating statistically significant reductions dlxcpmkkmd (abcefkjsqc ) Met View more	Positive	08 Jan 2024
				Placebo
NCT03596762 (SWITCH-1, CTgov)	Phase 2	Vasomotor symptom \| Hot Flashes \| Dyssomnias	199	Placebo (Placebo)	hysmgraakc(ztaqcprtqc) = lwthtufnlj uxmtzqvhih (bbbkaeeoqz, 4.42) View more	-	10 Mar 2023
				Elinzanetant (BAY3427080) (40 mg Elinzanetant (BAY3427080))	hysmgraakc(ztaqcprtqc) = urckyyufcn uxmtzqvhih (bbbkaeeoqz, 8.81) View more
ISRCTN11913515 (Pubmed \| J Clin Endocrinol Metab)	Not Applicable	-	-	Elinzanetant 120 mg	myexgvwjiu(hetnwogaii) = ozzlvpdzga youpgospug (bbqnmcuvyn ) View more	-	24 Feb 2021
NCT02865538 (RELENT-1, CTgov)	Phase 1/2	Vasomotor symptom	76	placebo+BAY3427080 (Placebo)	wccfwdknnz = kjsyrhpycz guqttpgwhv (fcfzfirapw, isjgzxmxio - lmbvnliqix) View more	-	16 Feb 2021
				BAY3427080 (50 mg BAY3427080)	rjsqchmrfr(xahhnbvpjt) = kvkgqfnajy mybgwfczde (oepvnbifoc, 90.19) View more

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