Delving into the Latest Updates on Elinzanetant with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BAY-3427080, GSK-1144814, NT-814

+ [1]

Target

NK1R x NK3

Action

antagonists

Mechanism

NK1R antagonists(Neurokinin 1 receptor antagonists), NK3 antagonists(Neurokinin 3 receptor antagonists)

Therapeutic Areas

Cardiovascular DiseasesOther DiseasesNervous System Diseases

Active Indication

Vasomotor symptomHot FlashesDyssomnias

Inactive Indication

Schizophrenia

Originator Organization

KaNDy Therapeutics Ltd.

Active Organization

Bayer AGBayer, Inc.

Bayer Plc

+ [1]

Inactive Organization

GSK Plc

NeRRe Therapeutics Ltd.

License Organization

KaNDy Therapeutics Ltd.

Bayer AG

Drug Highest PhaseApproved

First Approval Date

Canada (01 Jul 2025),

Hot Flashes

Regulation-

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Structure/Sequence

Molecular FormulaC33H35F7N4O3

InChIKeyDWRIJNIPBUFCQS-DQEYMECFSA-N

CAS Registry929046-33-3

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

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100 Translational Medicine associated with Elinzanetant

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100 Patents (Medical) associated with Elinzanetant

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34

Literatures (Medical) associated with Elinzanetant

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.

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.).

99

News (Medical) associated with Elinzanetant

25 Oct 2025

·pharma.economictimes.indiatimes.com

US FDA approves Bayer's menopause relief drug

Bengaluru: The U.S. Food and Drug Administration has approved Bayer's drug to ease hot flashes in menopausal women, the German company said on Friday, a welcome development following the regulator's three-month review extension. The drug, branded as Lynkuet , is a non-hormonal treatment designed to relieve moderate-to-severe vasomotor symptoms, also known as hot flashes, associated with menopause. Bayer said Lynkuet, a once-daily capsule to be taken at bedtime, is expected to be available in the U.S. beginning November. The drug's wholesale cost is $625 for a month's supply, though patient costs vary based on insurance, the company said. It has partnered with online pharmacy BlinkRx, through which eligible patients may pay as little as $25 a month via the Lynkuet Access, Savings and Support program. The FDA's approval for Lynkuet was based on three late-stage studies that showed the drug reduced the frequency and severity of hot flashes and eased sleep disturbances in menopausal women. Bayer has been gearing up to launch the drug this year, projecting annual peak sales of at least $1 billion, a strategic move to bolster its pharmaceuticals business amid mounting debt pressures. Its label, however, warns about possible drowsiness, increases in liver enzymes, risk of pregnancy loss, and seizures in people with a seizure history. Patients are advised to avoid grapefruit during treatment, Bayer said. The drug is already approved in Australia, Canada, the UK and Switzerland. An application is pending in the European Union. Japanese drugmaker Astellas' non-hormonal, oral treatment Veozah is the other approved treatment in the U.S. for hot flashes associated with menopause. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shilpi Majumdar)

Drug Approval

24 Oct 2025

·endpoints.news

Bayer gets FDA approval for hot flash treatment

The FDA has approved Bayer’s treatment for hot flashes caused by menopause, bolstering the company’s women’s health portfolio. Bayer said Friday that Lynkuet is the first dual neurokinin-targeted therapy to win FDA approval. The decision was based on three Phase 3 studies that showed the once-daily pill reduced the frequency and severity of moderate to severe hot flashes. It is expected to become available in the US next month. The FDA needed additional time to make its decision, extending the review of Lynkuet in July. The drug is also approved in the UK, Australia, Switzerland and Canada. Lynkuet is the latest product to join Bayer’s portfolio of women’s health-focused drugs and devices. The German pharmaceutical maker also sells contraceptives and a treatment for pelvic pain related to endometriosis. Bayer elected to divest from early-stage women’s health research more than two years ago , and no clinical-stage products focused on women’s health are in Bayer’s pipeline. The company has studied Lynkuet’s ability to quell hot flashes for reasons beyond just menopause, however. Bayer announced earlier this year that the drug reduced moderate to severe hot flashes for women on adjuvant endocrine therapy, a common treatment for breast cancer. With approval in hand, Bayer will compete against Astellas’ Veozah. Bayer has previously guided that Lynkuet has the potential for at least $1 billion in peak annual sales. Stefan Oelrich, head of Bayer’s pharmaceutical division, told investors at the beginning of the year that the company viewed Lynkuet as a “blockbuster candidate.” Astellas reported in April that Veozah sales eclipsed $220 million in fiscal 2024, an almost 364% jump from the previous fiscal year when the drug was first approved.

Drug ApprovalPhase 3Clinical Result

24 Oct 2025

·firstwordpharma.com

FDA signs off on Bayer's Lynkuet for menopausal hot flashes

After a three-month delay, the FDA on Friday approved Bayer's Lynkuet (elinzanetant) to treat moderate-to-severe vasomotor symptoms (VMS) linked to menopause. The therapy is the first dual neurokinin-1 and neurokinin-3 (NK-1,3) receptor antagonist to reach the US market, offering a new non-hormonal treatment alternative for women who experience hot flashes.Lynkuet's list price has been set at $625 for a 30-day supply, though eligible insured patients may pay as little as $25 a month through the company's savings programme with digital pharmacy service BlinkRx, a Bayer spokesperson confirmed to FirstWord. The drug will be available in the US beginning in November.The FDA green light for the oral, once-daily treatment was based on results from the Phase III OASIS 1 and 2 trials, which enrolled nearly 800 postmenopausal women between the ages of 40 and 65 years. Lynkuet reduced VMS frequency by 55.9% in OASIS 1 and 57.9% OASIS 2 at week 4, compared with respective rates of 31.4% and 35.7% for placebo. By week 12, reductions deepened to 65.2% and 67% for Lynkuet in the two trials, respectively, versus 42.2% and 45.9% among placebo recipients.Additionally, more than 80% of women treated with Lynkuet saw their VMS symptom frequency reduced by at least half by week 26, including those who had switched to the drug after 12 weeks on placebo.In the Phase III OASIS 3 long-term study, women taking Lynkuet demonstrated a sustained significant reduction in the frequency of moderate-to-severe VMS compared to placebo, with no signs of liver toxicity – a contrast to Astellas' rival NK-3 antagonist Veozah (fezolinetant), which has faced post-market scrutiny over liver enzyme elevations (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 Astellas drug carries a boxed warning about hepatoxicity.The original approval date for Lynkuet was originally set for July, but the decision was pushed back by up to three months after the FDA said it needed more time to conduct a full review of the submission.The FDA's decision follows approvals for Lynkuet in the UK, Canada, Australia and Switzerland, with a positive recommendation last month already issued by the European Medicines Agency's drug advisory body. A final decision from the European Commission is due in the coming months.

Clinical ResultPhase 3Drug ApprovalAccelerated Approval

100 Deals associated with Elinzanetant

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External Link

KEGG	Wiki	ATC	Drug Bank
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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
Dyssomnias	Phase 2	United States	Bayer AG	20 Nov 2018
Dyssomnias	Phase 2	United States	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	Canada	Bayer AG	20 Nov 2018
Dyssomnias	Phase 2	Canada	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	United Kingdom	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	United Kingdom	Bayer AG	20 Nov 2018
Schizophrenia	Phase 1	United Kingdom	GSK Plc	20 Oct 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05030584 (OASIS-3, Pubmed \| JAMA Intern Med)	Phase 3	Vasomotor symptom	628	Elinzanetant 120 mg	hjazdifuku(mgzcodrxdy) = numerical advantages for elinzanetant vs placebo for improving VMS frequency and severity hmsmzhikno (fdwgzlywtk ) 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	cgmmlisnqe(bhxkldyjpf) = xpvcvjemtz ebxlaisaqo (awssqkmrqz, 1.1) View more	Positive	30 May 2025
				Placebo	cgmmlisnqe(bhxkldyjpf) = epgitscjid ebxlaisaqo (awssqkmrqz, 1.2) View more
NCT05030584 (OASIS 4, PipelineReview) Manual	Phase 3	Vasomotor symptom	474	elinzanetant	jfdsusfhzu(nxbnvcwcev) = 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. msrrdojgvv (acepjgboga ) Met View more	Positive	09 Jan 2025
				placebo
NCT05099159 \| NCT05042362 (OASIS 2 \| OASIS 1, Pubmed \| JAMA)	Phase 3	Vasomotor symptom	-	Elinzanetant 120 mg	ddapgzojzy(ovsebugvaa) = fqeghsxesv jlltowqqbv (eiqdtxztfl, 6.6)	Positive	22 Oct 2024
				Placebo	ddapgzojzy(ovsebugvaa) = sdutpmmlsg jlltowqqbv (eiqdtxztfl, 13.9)
NCT05030584 (OASIS 3, NEWS 1 \| NEWS 2) Manual	Phase 3	Vasomotor symptom \| Hot Flashes	-	Elinzanetant	qrnvewxzbo(nalzlkqfdk) = zzfsilvokj bxaxtgmbfg (gxgjjkkqpa ) Met	Positive	10 Sep 2024
				Placebo	qrnvewxzbo(nalzlkqfdk) = xshknhjpbx bxaxtgmbfg (gxgjjkkqpa ) Met
NCT05042362 (OASIS-1, Biospace) Manual	Phase 3	Hot Flashes	396	Elinzanetant	xhrxoarbax(lpyqgyyprw) = 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. bwzidsrjks (sekfnvgwrg )	Positive	16 May 2024
NCT05099159 (OASIS-2, Biospace) Manual	Phase 3	Hot Flashes	400	Elinzanetant	awcvgjhppz(tmkohpffnr) = 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. ewkvvltkag (dcecswoynq )	Positive	16 May 2024
NCT05099159 \| NCT05042362 (OASIS 2, PipelineReview \| Company_Website) Manual	Phase 3	Vasomotor symptom	400	elinzanetant	rkrujnfgbu(jmeddkmlqy) = demonstrating statistically significant reductions ilfwdaiszh (dhkvmugred ) Met View more	Positive	08 Jan 2024
				Placebo
NCT03596762 (SWITCH-1, CTgov)	Phase 2	Dyssomnias \| Vasomotor symptom \| Hot Flashes	199	Placebo (Placebo)	aktiwgafjq(vymdwwwoyg) = bilrrikmfu rkjwnsmksc (hdrbkewpek, 4.42) View more	-	10 Mar 2023
				Elinzanetant (BAY3427080) (40 mg Elinzanetant (BAY3427080))	aktiwgafjq(vymdwwwoyg) = mkqdmlswiy rkjwnsmksc (hdrbkewpek, 8.81) View more
ISRCTN11913515 (Pubmed \| J Clin Endocrinol Metab)	Not Applicable	-	-	Elinzanetant 120 mg	unhqcsexvc(snvursdgzv) = nhxpkakatg mpjsdqtoli (kpzvdwtdai ) View more	-	24 Feb 2021