(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 Dec 2024·CPT-Pharmacometrics & Systems Pharmacology

Population pharmacokinetic–pharmacodynamic model of elinzanetant based on integrated clinical phase I and II data

Article

Author: Joseph, Shiju ; Willmann, Stefan ; Frechen, Sebastian ; Zhang, Yang ; Schultze‐Mosgau, Marcus‐Hillert ; Schneider, Annika R. P. ; Austin, Rupert ; Lloyd, Adam ; Solms, Alexander

Abstract:

Elinzanetant is a potent and selective dual neurokin‐1 (NK‐1) and ‐3 (NK‐3) receptor antagonist that is currently developed for the treatment of women with moderate‐to‐severe vasomotor symptoms (VMS) associated with menopause. Here, we report the development of a population pharmacokinetic (popPK) model for elinzanetant and its principal metabolites based on an integrated dataset from 366 subjects (including 197 women with VMS) collected in 10 phase I or II studies. The pharmacokinetics of elinzanetant and its metabolites could be well described by the popPK model. Within the investigated dose range of 40–160 mg, the oral bioavailability of elinzanetant was dose independent and estimated to be 36.7%. The clearance of elinzanetant was estimated to be 7.26 L/h and the central and peripheral distribution volume were 23.7 and 168 L. No intrinsic or extrinsic influencing factors have been identified in the investigated population other than the effect of a high‐fat breakfast on the oral absorption of elinzanetant. The popPK model was then coupled to a pharmacodynamic model to predict occupancies of the NK‐1 and NK‐3 receptors. After repeated once‐daily administration of the anticipated therapeutic dose of 120 mg elinzanetant, the model‐predicted median receptor occupancies are >99% for NK‐1 and >94.8% for NK‐3 during day and night‐time, indicating sustained and near‐complete inhibition of both target receptors during the dosing interval.

01 Dec 2024·Med

Searching for an oasis from the vasomotor symptoms of menopause: Could elinzanetant be the answer?

Article

Author: Kling, Juliana M ; Millstine, Denise M

In the OASIS 1 and 2 trials, elinzanetant, a selective neurokinin-1,3 receptor antagonist, was compared to placebo in women aged 40-65 with moderate to severe menopausal vasomotor symptoms (VMSs) at multiple sites over 26 weeks. Elinzanetant significantly reduced VMS frequency and severity and improved sleep disturbance and menopause-related quality of life compared to placebo with few adverse side effects.¹.

22 Oct 2024·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause

Article

Author: Haberland, Claudia ; Joffe, Hadine ; Soares, Claudio N. ; Simon, James A. ; Parke, Susanne ; Pinkerton, JoAnn V. ; Krahn, Ulrike ; Nappi, Rossella E. ; Thurston, Rebecca C. ; Caetano, Cecilia ; Haseli Mashhadi, Nazanin ; Maki, Pauline M. ; Mellinger, Uwe ; Panay, Nick ; Seitz, Christian ; Zuurman, Lineke

Importance:

Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed.

Objective:

To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms.

Design, Setting, and Participants:

Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023).

Intervention:

Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 weeks followed by elinzanetant, 120 mg, for 14 weeks.

Main Outcomes and Measures:

Primary end points included mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, measured by the electronic hot flash daily diary. Secondary end points included Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and Menopause-Specific Quality of Life questionnaire total score from baseline to week 12.

Results:

Eligible participants (mean [SD] age, OASIS 1: 54.6 [4.9] years; OASIS 2: 54.6 [4.8] years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). A total of 309 (78.0%) and 324 (81.0%) completed OASIS 1 and 2, respectively. For the elinzanetant and placebo groups, the baseline mean (SD) VMS per 24 hours were 13.4 (6.6) vs 14.3 (13.9) (OASIS 1) and 14.7 (11.1) v 16.2 (11.2) (OASIS 2). Baseline VMS severity was 2.6 (0.2) vs 2.5 (0.2) (OASIS 1) and 2.5 (0.2) vs 2.5 (0.2) (OASIS 2). Elinzanetant significantly reduced VMS frequency vs placebo at week 4 (OASIS 1: −3.3 [95% CI, −4.5 to −2.1], P &lt; .001; OASIS 2: −3.0 [95% CI, −4.4 to −1.7], P &lt; .001) and at week 12 (OASIS 1: −3.2 [95% CI, −4.8 to −1.6], P &lt; .001; OASIS 2: −3.2 [95% CI, −4.6 to −1.9], P &lt; .001). Elinzanetant also improved VMS severity vs placebo at week 4 (OASIS 1: −0.3 [95% CI, −0.4 to −0.2], P &lt; .001; OASIS 2: −0.2 [95 CI, −0.3 to −0.1], P &lt; .001) and week 12 (OASIS 1: −0.4 [95% CI, −0.5 to −0.3], P &lt; .001; OASIS 2: −0.3 [95% CI, −0.4 to −0.1], P &lt; .001). Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable.

Conclusions and Relevance:

Elinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS.

Trial Registration:

ClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159

News (Medical) associated with Elinzanetant

15 Jan 2025

·pipelinereview.com

Bayer’s Pharma Growth Strategy Progressing Well as Pipeline Advances

WHIPPANY, NJ, USA I January 14, 2025 I On the occasion of the 43rd J.P. Morgan Healthcare Conference in San Francisco, Bayer AG announces further progress in its pharmaceutical growth strategy with multiple regulatory filing submissions underway for key growth drivers darolutamide, finerenone, and elinzanetant. “We are successfully delivering on our ambitious business goals despite significant headwinds. At the same time, the value of our pipeline is growing by accelerating breakthrough innovations,” said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. “Our new operating model is visibly becoming a key enabler to drive growth and efficiency gains.” Topline improved and poised for future growth Bayer continues to strengthen its leadership position in prostate cancer with the anticipated launch of a third indication in 2025 for the oral androgen receptor inhibitor (Ari)darolutamide, marketed under the brand name NUBEQA ® ,supported by data from the ARANOTE trial. Darolutamide plus androgen deprivation therapy (ADT) now has positive data both with and without chemotherapy (docetaxel) based on two pivotal Phase III studies (ARASENS and ARANOTE) in metastatic hormone-sensitive prostate cancer (mHSPC). Bayer recently submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for this third indication for darolutamide in addition to filings in the U.S. and the EU earlier in 2024. NUBEQA achieved global blockbuster status in September 2024 after crossing the threshold of one billion euros in annual sales. Additionally, NUBEQA is now the fastest growing androgen receptor inhibitor in the U.S., with nearly 45,000 patients in the U.S. and 100,000 patients globally treated as of the end of 2024. For important risk and use information about NUBEQA, please see the full Prescribing Information . In Cardiovascular, Bayer submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and CDE of China’s NMPAfor finerenone, marketed as KERENDIA ® , for the treatment of patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, initiating a major step forward in expanding its reach. Further regulatory filings are planned with a potential market launch by the end of 2025. Filing submissions are based on positive results from the Phase III FINEARTS-HF trial that showed finerenone achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as either an unplanned hospitalization for HF or an urgent HF visit, by 16% in patients with HF and a LVEF of ≥40% compared to placebo in addition to a patients’ prescribed treatment regimen. The robust data from Kerendia’s clinical development program underscore its potential to become a pillar of therapy for patients with chronic kidney disease associated with Type 2 Diabetes and patients with heart failure with an LVEF of ≥40%. For important risk and use information about KERENDIA, please see the full Prescribing Information . In Women´s Healthcare, another significant clinical milestone for investigational compound elinzanetant was secured in early 2025 following three positive Phase III readouts in 2024 (OASIS 1,2,3). OASIS 4, which was conducted outside of the U.S., is a Phase III study evaluating elinzanetant as a non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing breast cancer. 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. The study also achieved all secondary endpoints demonstrating reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1 as well as maintaining the effects over the study period. The detailed results from OASIS 4 are planned to be presented at an upcoming scientific congress. Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause. In Radiology, Bayer is advancing its pipeline. A significant milestone was achieved with its Phase III QUANTI clinical development program, which evaluated the investigational compound gadoquatrane. The first data from the program showed that gadoquatrane successfully achieved its primary endpoint, highlighting its potential to offer a low dose contrast agent option to patients. The QUANTI program showcases Bayer’s leadership in radiology and its commitment to advancing innovation in medical imaging. Pipeline value improved and early lead positions strengthened Bayer is making significant progress with its cell and gene therapy platform, achieving important clinical trial milestones, especially in the field of Parkinson´s disease. Bemdaneprocel will directly advance to Phase III clinical development in Parkinson’s disease, based on positive data from the Phase I exPDite trial. Bemdaneprocel is an investigational stem cell-based therapy that surgically implants dopamine-generating nerve cell precursors into the brain. The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation for its innovative potential in treating Parkinson’s disease. AB-1005 is advancing in Phase II with the randomization of participants in the REGENERATE-PD clinical trial focusing on patients with moderate-stage Parkinson’s disease. AB-1005 is an investigational AAV-based gene therapy that delivers the human glial cell line-derived neurotrophic factor (GDNF) transgene to the brain to potentially protect and restore dopamine-generating neurons. AB-1005 has received U.S. FDA Fast Track and UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport designations, highlighting its potential to address significant unmet medical needs. As part of its transformation, Bayer has sharpened its focus in R&D to build a highly differentiated pipeline for long-term growth in oncology, cardiology and renal diseases, neurology and rare diseases, and immunology. Through rigorous assessment and prioritization, Bayer Pharmaceuticals is now fully focused on the areas of greatest unmet need and highest value potential. Targeted investments in R&D and platform companies in recent years are already strengthening Bayer’s early and late pipelines. With Vividion´s acquisition of the precision oncology platform company Tavros Therapeutics, Bayer continues to leverage its chemoproteomics platform technology to unlock traditionally undruggable targets with precision small-molecule therapeutics. It has initiated Phase I trials with oral KEAP1 activator in solid tumors and oral STAT3 inhibitor in solid and hematologic malignancies and has IND-enabling programs including a RAS-P13KCA program for RAS-driven cancers. Additionally in the field of precision oncology, investigational BAY 2927088, an oral, small molecule, tyrosine kinase inhibitor as a potential new targeted therapy for patients with non-small cell lung cancer (NSCLC) harboring HER2 activating mutations, showed promising results as a second line therapy in the ongoing Phase I/II SOHO-01 study evaluating safety and efficacy. Its potential is underscored by Breakthrough Therapy Designations from both the FDA and Chinese CDE. Beyond the SOHO-01 trial, BAY 2927088 is also being assessed for its potential as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations in the SOHO-02 trial. Further, a Phase I clinical trial with BAY3498264, an investigational oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor, has recently been initiated (outside of the US). The open-label, first-in-human, dose escalation study will evaluate patients with KRAS G12C-mutated metastatic cancer. This innovative approach has the potential to enhance the treatment options available for patients, offering the possibility to reduce or stop tumor progression. Targeted Radionuclide Therapy (TRT) is a strategic area of focus in Oncology precision drug development at Bayer, building on more than 10 years of real-world experience with radium Ra 223 dichloride injection therapy, marketed as XOFIGO ® , for patients with metastatic castration-resistant prostate cancer. Bayer´s evolving TRT portfolio includes novel targeting approaches which combine alpha radionuclides such as actinium-225 with different targeting moieties, including antibodies, small molecules or peptide-based molecules. 225 Ac-pelgifatamab (BAY 3546828) and 225 Ac-PSMA-Trillium (BAY 3563254), two candidates targeting PSMA (prostate specific membrane antigen), are currently in Phase I clinical trials in patients with advanced metastatic castration resistant prostate cancer (mCRPC). For important risk and use information about XOFIGO, please see the full Prescribing Information . In the field of cardiovascular diseases, Bayer is making progress with its Phase II assets. With BAY3283142, an investigational soluble guanylate cyclase (sGC) activator in patients with chronic kidney disease (CKD), Bayer has entered into a Phase II clinical study. By modulating sGC via a heme-independent pathway, the investigational sGC activator now represents a new class of potential future drugs that could offer an advantage in conditions of high oxidative stress such as in diabetic nephropathy. With the anti-alpha2 antiplasmin antibody program, Bayer is developing a new modality and mechanism of action-based thrombolytic agent. Based on investigational research, the antibody works by specifically blocking the endogenous plasmin inhibitor, α2AP, potentially leading to the lysis of acute embolic or thrombotic clots with a tolerable safety profile. The investigational antibody is currently being evaluated in Phase II in patients with deep vein thrombosis and could be used for indications of high medical relevance. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . © 2025 Bayer BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at www.pharma.bayer.com Our online press service is just a click away: www.bayer.us/en/newsroom Follow us on Facebook: http://www.facebook.com/pharma.bayer Follow us on X: https://X.com/BayerUS SOURCE: Bayer

Phase 3Clinical ResultPhase 1Phase 2Drug Approval

10 Jan 2025

·pmlive.com

Bayer’s non-hormonal menopause drug shows promise in phase 3 breast cancer trial

Bayer has shared positive results from a late-stage study of its investigational non-hormonal drug in patients experiencing vasomotor symptoms (VMS) as a result of breast cancer treatment. The phase 3 OASIS 4 study has been evaluating the candidate, elinzanetant, as a treatment for moderate-to-severe VMS caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in those who are at high risk of developing breast cancer. VMS, such as hot flashes, are reported by up to 80% of women at some point during the menopausal transition, and over one-third report severe symptoms. Those receiving adjuvant endocrine therapy, including tamoxifen or aromatase inhibitors, for the treatment or prevention of breast cancer may also experience VMS. There are currently no licensed treatment options for this patient population. OASIS 4 met its primary endpoint, with elinzanetant resulting in statistically significant mean reductions in the frequency of moderate-to-severe VMS from baseline to weeks four and 12 compared to placebo. All key secondary endpoints were also achieved, demonstrating a reduction in severity of VMS at weeks four and 12, a reduction in frequency of VMS at week one, as well as improvements in sleep disturbances and menopause-related quality of life at week 12 compared to placebo. Additionally, the safety profile of elinzanetant observed over 52 weeks was generally consistent with previously conducted studies and published data on the drug in postmenopausal women with VMS. Administered orally once daily, elinzanetant is a dual neurokinin-1, 3 receptor antagonist in late-stage clinical development to treat moderate-to-severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. The latest results for the drug build on positive results from the phase 3 OASIS 1, 2 and 3 trials in women with moderate-to-severe VMS associated with menopause. Fatima Cardoso, principal investigator of OASIS 4, said: “The positive results from OASIS 4 bring us one step closer to a much-needed non-hormonal option for managing VMS in breast cancer patients and women at risk of breast cancer.” Submissions for marketing authorisations for elinzanetant are ongoing in the US, EU, UK and other markets globally, Bayer outlined.

Phase 3Clinical Result

09 Jan 2025

·endpts.com

Bayer says elinzanetant quelled hot flashes in women undergoing cancer treatment

As Bayer awaits an FDA decision on its non-hormonal treatment for hot flashes caused by menopause, the company is unveiling new results in a slightly different patient population: women whose hot flashes were caused by breast cancer therapy. The company said its experimental drug elinzanetant met all the primary and secondary endpoints in a Phase 3 trial enrolling women whose vasomotor symptoms — more commonly known as hot flashes — are caused by adjuvant endocrine therapy. Bayer has yet to report any hard data but said elinzanetant reduced both the frequency and severity of symptoms at weeks 4 and 12. Adjuvant endocrine therapy is standard treatment for many breast cancer patients that can come with hot flashes as a side effect. In addition to improving symptoms, Bayer said the data suggest elinzanetant helped patients get better sleep compared to placebo. The company expects an FDA decision for menopause-related hot flashes in the second half of 2025. In that setting, elinzanetant will compete with Astellas’ Veozah, which was approved by the FDA in May 2023 and works in a similar fashion. Veozah targets a receptor called neurokinin 3, or NK3, which is involved in the brain’s regulation of body temperature. Bayer’s elinzanetant also targets NK3, as well as another receptor called NK1. Veozah had a sluggish commercial launch, generating 7.3 billion yen in 2023 ($46 million) compared to the company’s initial projections of 53 billion yen ($335 million). Executives have cited insurance coverage as a key hurdle, but noted during Astellas’ most recent earnings call in October that “prescriptions are continuing their upward trend,” according to an AlphaSense transcript. The company raised its Veozah sales projections for its fiscal year 2024, which ends in March. The FDA also added a boxed warning , its most serious warning, to Veozah’s label in December over a risk of “risk of rare but serious liver injury.” The update was triggered by a patient whose signs and symptoms of liver injury were reported to the FDA’s adverse event reporting system post-launch. After stopping treatment, the FDA said the patient’s symptoms “gradually went away,” and their blood tests returned to normal. A Bayer spokesperson told Endpoints News that to date, “clinical evaluation has not indicated any statistically significant liver safety concerns for elinzanetant.” The company said safety in the latest study was “generally consistent with previously conducted studies and published data on elinzanetant in postmenopausal women with VMS.” Astellas launched a Phase 3 trial in August studying women who experience hot flashes related to breast cancer treatment.

Clinical ResultPhase 3Drug ApprovalAccelerated Approval

100 Deals associated with Elinzanetant

External Link

KEGG	Wiki	ATC	Drug Bank
-	Elinzanetant	-	-

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Vasomotor symptom	NDA/BLA	CA	Bayer, Inc.	01 Sep 2024
Hot Flashes	NDA/BLA	US	Bayer AG	02 Aug 2024
Menopausal symptoms	Phase 3	US	Bayer AG	29 Oct 2021
Menopausal symptoms	Phase 3	CA	Bayer AG	29 Oct 2021
Menopausal symptoms	Phase 3	CZ	Bayer AG	29 Oct 2021
Menopausal symptoms	Phase 3	DE	Bayer AG	29 Oct 2021
Menopausal symptoms	Phase 3	IT	Bayer AG	29 Oct 2021
Menopausal symptoms	Phase 3	NO	Bayer AG	29 Oct 2021
Menopausal symptoms	Phase 3	PL	Bayer AG	29 Oct 2021
Menopausal symptoms	Phase 3	PT	Bayer AG	29 Oct 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05030584 (OASIS 4, PipelineReview) Manual	Phase 3	Vasomotor symptom	474	elinzanetant	dugoqlkecw(uobiwjmlsj) = 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. uztbxurkjx (laemgyhxgb ) Met View more	Positive	09 Jan 2025
				placebo
NCT05099159 \| NCT05042362 (OASIS 2 \| OASIS 1, Pubmed \| JAMA)	Phase 3	Vasomotor symptom	-	Elinzanetant 120 mg	xzuihvryut(ocxlvabxes) = xcqmjrrvks yauvzbetld (pwjlycyhll, 6.6)	Positive	22 Oct 2024
				Placebo	xzuihvryut(ocxlvabxes) = ajavwjdcft yauvzbetld (pwjlycyhll, 13.9)
NCT05030584 (OASIS 3, NEWS) Manual	Phase 3	Vasomotor symptom \| Hot Flashes	-	Elinzanetant	oaahdlrkmr(svggohaqeb) = rqozqrdchg czllxbhhre (nmxmytenad ) Met	Positive	10 Sep 2024
				Placebo	oaahdlrkmr(svggohaqeb) = rbyebwyorf czllxbhhre (nmxmytenad ) Met
NCT05099159 (OASIS-2, Biospace) Manual	Phase 3	Hot Flashes	400	Elinzanetant	grvpfwkmsj(tuiwkhvzvf) = 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. dmehomfwcs (xpooygiogo )	Positive	16 May 2024
NCT05042362 (OASIS-1, Biospace) Manual	Phase 3	Hot Flashes	396	Elinzanetant	whspndlsrc(onfwzkyoyk) = 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. ybkgtqyxhk (byhikqhtwv )	Positive	16 May 2024
NCT05099159 \| NCT05042362 (OASIS 2, PipelineReview) Manual	Phase 3	Vasomotor symptom	400	elinzanetant	noxvmsscjo(zawdizgybe) = demonstrating statistically significant reductions deltejotqt (rdncrnrzlj ) Met View more	Positive	08 Jan 2024
				Placebo
NCT03596762 (SWITCH-1, CTgov)	Phase 2	Vasomotor symptom \| Hot Flashes \| Dyssomnias	199	Placebo (Placebo)	dokqfybpsp(htjbruwenp) = vwhjygcbwz edldgtcjyy (ylyuqwxowm, uhdaftieeh - gmpitrqqgc) View more	-	10 Mar 2023
				Elinzanetant (BAY3427080) (40 mg Elinzanetant (BAY3427080))	dokqfybpsp(htjbruwenp) = mmpqswjokp edldgtcjyy (ylyuqwxowm, gqjjlprarn - vnfcrfiimb) View more
ISRCTN11913515 (Pubmed \| J Clin Endocrinol Metab)	Not Applicable	-	-	Elinzanetant 120 mg	mnxqkapkgc(ambhwiyxiz) = ljutzeczpi bjzvifmuge (dpvupwrggo ) View more	-	24 Feb 2021
NCT02865538 (RELENT-1, CTgov)	Phase 1/2	Vasomotor symptom	76	placebo+BAY3427080 (Placebo)	dumwiunjcy(haryngqnsx) = gsgnraqejx uxqhuyfllv (eltnrezkfw, rtzaubnfhp - sfapixylst) View more	-	16 Feb 2021
				BAY3427080 (50 mg BAY3427080)	lsmhdlxkcf(vlfrhbjafk) = ucimeczwuk urqtmbjroz (ayogcnerte, yjhuxsynog - awfkekkpem) View more
NCT03596762 (SWITCH-1, ENDO2020)	Phase 2	Vasomotor symptom	199	NT-814 40 mg	zczpjrvyxz(zcfyqaemph) = NT-814 was well-tolerated; most AEs were mild or moderate and there were no serious AEs related to treatment pcrdpcuybb (udduhsxuvk )	Positive	08 May 2020
				NT-814 80 mg

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis