A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants

This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.

Start Date22 Jul 2026

Sponsor / Collaborator

Bayer AG

CTIS2026-525569-30-00

/ Not yet recruitingPhase 1

A study to learn how a high-fat meal affects the way elinzanetant is taken up by the body in healthy women

Start Date15 Jul 2026

Sponsor / Collaborator

Bayer AG

NCT07077395

/ RecruitingPhase 2IIT

Finding Links Between Hot flASHes and CardioVascular Disease

The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?

Start Date01 Mar 2026

Sponsor / Collaborator

The Massachusetts General Hospital

100 Clinical Results associated with Elinzanetant

100 Translational Medicine associated with Elinzanetant

100 Patents (Medical) associated with Elinzanetant

Literatures (Medical) associated with Elinzanetant

01 Aug 2026·DRUG SAFETY

Liver Safety of the Dual Neurokinin-1/-3 Receptor Antagonist Elinzanetant

Review

Author: Andrade, Raúl J ; Larrey, Dominique ; Trajanovic, Mila ; Horsmans, Yves ; Anderson, Richard A ; Zuurman, Lineke ; Groettrup-Wolfers, Esther ; Lewis, James H

BACKGROUND:

Elinzanetant is a selective dual neurokinin (NK)-1/-3 receptor antagonist for the treatment of moderate-to-severe vasomotor symptoms associated with menopause or caused by endocrine therapy. Elinzanetant has been approved by health authorities in several countries. The occurrence of elevated liver enzymes has been observed in clinical use with NK-3 receptor antagonists, e.g., fezolinetant and pavinetant, with recommendations for liver monitoring in the fezolinetant labeling information. Therefore, a thorough evaluation of the liver safety data from clinical trials with elinzanetant was undertaken.

OBJECTIVE:

To summarize available hepatic safety data from the clinical development program of elinzanetant.

METHODS:

The potential risk of drug-induced liver injury (DILI) associated with elinzanetant was evaluated on the basis of the analysis of 24 phase 1 studies, three phase 2 studies (RELENT-1, SWITCH-1, NIRVANA), and four randomized, placebo-controlled phase 3 studies (OASIS 1‒4). Liver safety assessments were conducted throughout the studies as per protocol. In the phase 3 studies, a liver safety monitoring board (LSMB) performed an independent and blinded review of cases meeting close liver observation criteria, in alignment with US Food and Drug Administration DILI Guidance and the Council for International Organizations of Medical Sciences 2020 consensus on DILI. An independent data and safety monitoring board monitored the general safety of the participants.

RESULTS:

In the clinical program (phases 1‒3), there was no imbalance between the elinzanetant and placebo groups in alanine aminotransferase (ALT) elevations up to 5×, 10×, or 20× the upper limit of normal (ULN). In the pooled studies that included postmenopausal women, during weeks 1‒52 of treatment, ALT or aspartate transaminase (AST) elevations ≥ 3× ULN were observed in 1.2% of participants treated with elinzanetant 120 mg and in 1.0% of participants treated with placebo. In addition, there were no cases meeting Hy's law, and no indication of cholestatic injury. The LSMB assessed two cases on elinzanetant (2 out of 1697 participants, 0.12%) and one case on placebo (1 out of 1028, 0.10%) as probably related to study drug. For the cases on elinzanetant, one participant had a peak ALT level 7.4× ULN and the other had a peak ALT 3.5× ULN. Alkaline phosphatase and total bilirubin levels remained within reference range; both cases were mild and reversible. The peak ALT for the participant on placebo was 3.6× ULN. No case was classified as highly likely or definite.

CONCLUSIONS:

The aggregated phase 1‒3 clinical data, supported by preclinical toxicology and individual case adjudications of participants with elevated liver enzymes, suggest that there is a low risk of liver toxicity for elinzanetant. On the basis of these data, liver test monitoring was considered unnecessary in clinical practice by the LSMB (video abstract available online). Supplementary file2 (MP4 73923 KB).

01 Aug 2026·BREAST

Neurokinin pathway antagonists for vasomotor symptoms in women with breast cancer: focus on elinzanetant and fezolinetant

Review

Author: Arecco, Luca ; Lambertini, Matteo ; Pogoda, Katarzyna

Vasomotor symptoms (VMS) have a major impact on quality-of-life in women with hormone receptor-positive breast cancer receiving adjuvant endocrine therapy. As menopause hormone therapy is contraindicated in this setting, effective non-hormonal treatment options are urgently needed. We performed a focused narrative review of neurokinin (NK) receptor antagonists for VMS, including the OASIS-1-4 program for elinzanetant and the SKYLIGHT, MOONLIGHT, and DAYLIGHT programs for fezolinetant, with emphasis on breast cancer-specific data, safety, drug-drug interactions, and selected special populations relevant to oncology practice. Elinzanetant, a dual NK1/NK3 receptor antagonist approved by the European Medicines Agency and the U.S. Food and Drug Administration, provides the first phase III evidence in the specific cohort of patients with breast cancer receiving endocrine therapy. In the OASIS-4 trial, elinzanetant demonstrated rapid and clinically meaningful reductions in moderate-to-severe VMS, with sustained improvements in sleep and menopause-specific quality of life and a favorable tolerability profile without a signal for clinically significant hepatotoxicity. Fezolinetant, a selective NK3 receptor antagonist approved for menopausal VMS in the general population, has shown robust efficacy across multiple phase III trials; however, its use requires liver function monitoring due to hepatotoxicity, and its role in breast cancer survivors remains under investigation. Safety considerations of NK receptor antagonists include their use alongside CDK4/6 inhibitors. With breast cancer-specific data for elinzanetant and ongoing trials of fezolinetant, these agents will change clinical practice by improving symptom control and adherence to adjuvant endocrine therapy overall.

01 Aug 2026·INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS

Elinzanetant: Efficacy and safety in the management of vasomotor symptoms in postmenopausal women, a systematic review and meta‐analysis with grading of recommendations assessment, development, and evaluation assessment

Review

Author: Ayman, Ahmed ; Abdelaziz Ismail, Rahma ; Azzam, Rabie ; Aranda, Mohamed ; Ibrahim, Ahmed ; Sameh Shaheen, Rahmah ; Ashraf Aldbash, Asmaa ; Osama, Ahmed ; Afifi, Eslam

Abstract:

Background:

Menopause is frequently associated with different symptoms and signs, such as vasomotor symptoms (VMSs), which can affect women's quality of life. While hormonal therapy is considered the traditional and most used medication for controlling these VMSs associated with menopause, neurokinin (NK) receptor antagonists resemble a novel, promising generation of medications that provide fewer adverse events compared to hormonal therapy. Elinzanetant is the first drug that can act on both NK‐1 and 3 receptors by selectively antagonizing them. It has also been developed for the management of moderate‐to‐severe VMSs.

Objectives:

We aim to investigate the effectiveness and safety of elinzanetant compared to placebo in the management of moderate and severe VMSs that are associated with postmenopausal women.

Method:

We conducted a search of four databases (PubMed, Cochrane, Web of Science, and Scopus) using the following search strategy: ([Elinzanetant) OR [NT‐814] OR [BAY 3427080] OR (NK Receptor Antagonist]) AND ([Menopausal Symptoms] OR [Flashes Vasomotor Symptoms] OR (VMS)) with no search restrictions or filters applied.

Selection Criteria:

We included randomized controlled clinical trials (RCTs) comparing elinzanetant to placebo in post‐menopausal women suffering from frequent moderate‐to‐severe VMSs that reported both efficacy and safety outcomes. We used a uniform Google Sheet designed to collect data from our included RCTs. After data collection, we used Review Manager Software (RevMan) V.5.4.1. to perform all the analyses and plots using a risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes and mean difference (MD) with a 95% CI for continuous outcomes. We conducted risk of bias assessment using Risk of Bias Assessment tool‐2 (ROB2).

Results:

We included five RCTs in our review with 1699 participants. Our results reported that elinzanetant demonstrated a statistically significant difference in reducing both frequency and severity of VMSs at week 4 compared to placebo (MD = −2.75, 95% CI: [−3.83, −1.67], P < 0.00001; MD = −0.29, 95% CI: [−0.35, −0.22], P < 0.00001, respectively). These results were maintained at week 12 for both frequency (MD = −2.30, 95% CI: [−3.00, −1.59], P < 0.00001) and severity (MD = −0.35, 95% CI: [−0.43, −0.28], P < 0.00001). Compared to placebo, elinzanetant was associated with a higher incidence of treatment‐emergent adverse events (TEAEs) (RR = 1.12, 95% CI: [1.03, 1.22], P < 0.01), TEAEs causing permanent discontinuation of the study drug (RR = 2.18, 95% CI: [1.45, 3.28], P = 0.0002), drug‐related TEAEs (RR = 1.92, 95% CI: [1.53, 2.41], P < 0.00001), headache (RR = 2.19, 95% CI: [1.38, 3.49], P = 0.0009), somnolence (RR = 2.96, 95% CI: [1.42, 6.17], P = 0.004), and fatigue (RR = 3.39, 95% CI: [1.77, 6.49], P = 0.0002). However, no statistically significant difference was observed in the incidence of serious TEAEs (RR = 1.70, 95% CI: [0.82, 3.54], P = 0.15).

Conclusion:

Elinzanetant showed significant efficacy in reducing both the frequency and severity of VMSs associated with post‐menopausal women at different time points, while concurrently improving outcomes associated with women's quality of life. While elinzanetant was associated with a higher incidence of non‐serious adverse events such as headache, somnolence, and fatigue, which led to more treatment discontinuations, it did not increase the risk of serious adverse events compared to placebo, indicating an acceptable safety profile. Conclusively, our results indicate that elinzanetant represents a promising alternative for VMS management; however, it should not replace the clinical assessment of eligibility for hormone therapy. Further studies are required to confirm its long‐term safety and sustained effectiveness.

116

News (Medical) associated with Elinzanetant

26 Aug 2026

·www.biospace.com

LYNKUET® (elinzanetant) Receives Expanded Market Authorization in Canada for Treatment of Moderate to Severe Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy (AET) Related to Breast Cancer

Expanded authorization introduces a treatment option for women experiencing moderate to severe hot flashes and/or night sweats caused by adjuvant endocrine therapy (AET) related to breast cancer LYNKUET ® is the first NK-1 and NK-3 receptor antagonist indicated in the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause Expanded indication is supported by the OASIS-4 study, which evaluated treatment in women with moderate to severe VMS caused by adjuvant endocrine therapy for breast cancer 1 MISSISSAUGA, Ontario--(BUSINESS WIRE)--Bayer Inc. announced today that Health Canada has issued a Notice of Compliance (NOC) expanding the indication of LYNKUET ® (elinzanetant) to include the treatment of moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy (AET) related to breast cancer. With today’s authorization, LYNKUET ® becomes the first approved treatment option in Canada for this patient population. This authorization builds on Health Canada's July 2025 market authorization of LYNKUET ® for the treatment of moderate to severe VMS associated with menopause. 1 “For women receiving endocrine therapy for breast cancer, hot flashes, night sweats and sleep disruption can have a profound impact on daily life and treatment experience. This market authorization introduces a new treatment option designed to address moderate to severe vasomotor symptoms (also known as hot flashes and night sweats) in a population with limited therapeutic alternatives,” says Viktoria Friedrich, Country President and General Manager for the Pharmaceuticals division in Canada. In a recent Canadian study, moderate to severe VMS were associated with a 30.2% impairment in work productivity and a 35.7% impairment in daily activities. 2 About Vasomotor Symptoms in Women Receiving Adjuvant Endocrine Therapy Breast cancer is the most commonly diagnosed cancer among women in Canada, with approximately 1 in 8 of women expected to develop it during their lifetime. 3 For patients with hormone receptor-positive (HR+) breast cancer, endocrine therapy – such as tamoxifen and aromatase inhibitors – is the standard of care. 4 While endocrine therapy reduces rates of recurrence, it may also cause side effects such as hot flashes, night sweats and sleep disruption that can affect quality of life. 5 Menopause hormone therapy for VMS is not recommended for women with a history of HR+ breast cancer, making effective non-hormonal options an important clinical need. 4,5 Recent Canadian research found that moderate to severe VMS significantly affected quality of life, sleep, work productivity and daily activities among affected women. 2 About the OASIS-4 Study The Phase III OASIS-4 trial evaluated the safety and efficacy of elinzanetant in women receiving adjuvant endocrine therapy who experienced moderate to severe VMS. 6 It is part of the broader OASIS clinical development program investigating elinzanetant in women affected by VMS, which also includes OASIS-1, OASIS-2 and OASIS-3 in postmenopausal women. 6,7,8 Across the OASIS program, elinzanetant demonstrated significant reductions in the frequency of VMS compared to placebo and a safety pro was similar to that of placebo. 6,7,8 About LYNKUET ® LYNKUET ® is a once-daily oral treatment and the first dual neurokinin-targeted therapy, acting as a selective antagonist of both the neurokinin-1 (NK-1) and neurokinin-3 (NK-3) receptors. 1 It acts by blocking NK-1 and NK-3 receptor signalling on KNDy neurons, which are hyperactivated due to estrogen decline during menopause or treatment with endocrine therapy, thereby modulating neuronal activity involved in thermoregulation. 1 In Canada, LYNKUET ® is now indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause and for the treatment of moderate to severe VMS caused by adjuvant endocrine therapy (AET) related to breast cancer. 1 Community Perspectives Perspectives from Canada’s health community following today’s announcement: “When we talk about treating breast cancer, we need to ensure patients are supported through treatment. Adjuvant endocrine therapy is one of our most powerful tools for helping prevent recurrence, but it can leave women managing severe hot flashes that negatively affect quality of life and, too often, lead them to stop the very therapy that protects them. For a long time, our options were limited, especially because hormone-based relief is not appropriate for many breast cancer patients. The introduction of LYNKUET ® in Canada is a meaningful step forward. As a hormone-free treatment, it gives us a new, non-hormonal way to treat these ongoing symptoms and help women stay on therapy.” – Dr. Christine Brezen-Masley, Medical Oncologist and Director of the Marvelle Koffler Breast Centre at Mount Sinai Hospital, and Medical Director of the Cancer Program for Sinai Health System in Toronto, Canada. “Breast cancer care can't be done in isolation. We must also address the lasting effects of treatment that shape a person's quality of life. For too long, medically induced menopause symptoms like hot flashes and night sweats have been an overlooked consequence of breast cancer care. The availability of a new non-hormonal treatment reflects the progress that is possible when research drives innovation beyond the cancer itself. It is another step toward a more personalized, evidence-based approach, where survivorship and supportive therapies are recognized as essential components of modern breast cancer care.” – Kimberly Carson, CEO, Breast Cancer Canada “Vasomotor symptoms can have a significant impact on quality of life for people living with breast cancer. For many individuals receiving adjuvant endocrine therapy, symptoms such as hot flashes and night sweats can affect daily functioning and overall wellbeing. The availability of a new treatment option is a welcome step forward in addressing a longstanding gap in care for the breast cancer community.” – Cathy Ammendolea, Chair of the Board of the Canadian Breast Cancer Network “At Rethink, we regularly hear from people on endocrine therapy about how hot flashes, night sweats and disrupted sleep impact their day to day lives. These symptoms aren’t just uncomfortable, they can affect adherence to treatment, mental health, and overall well-being at an already challenging time. What’s particularly significant is that the evidence behind elinzanetant examines it’s use and impact in people with breast cancer, not simply adapted from another population. That kind of disease specific focus is important, and we’re encouraged to see it reflected here.” – MJ DeCoteau, Founder & Executive Director, Rethink Breast Cancer About Women’s Health at Bayer Bayer is committed to delivering Health for All by advancing a portfolio of innovative treatments in women's health. Bayer offers a wide range of contraceptive options, therapies for menopause management and gynecological conditions, and continues to invest in research and development to address unmet needs across women's health including menopause, endometriosis and oncology-related quality-of-life care. 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References: Bayer Inc. Lynkuet ® (elinzanetant) Product Monograph . August 12, 2026. Available at: Yuksel N, Todorova L, Scrine L, Rea C, Bouchard C. Prevalence and impact of vasomotor symptoms due to menopause among women in Canada: A subgroup analysis from the Women with Vasomotor Symptoms Associated with Menopause (WARM) Study. Menopause. 2025;32(1):38-44. Canadian Cancer Society. Hormone therapy for breast cancer . Accessed July 2026. Available at: Yuksel N, Evaniuk D, Huang L, et al. Guideline No. 422a: Menopause: Vasomotor Symptoms, Prescription Therapeutic Agents, Complementary and Alternative Medicine, Nutrition, and Lifestyle. J Obstet Gynaecol Can . 2021;43(10):1188-1204. Cardoso F, Parke S, Brennan DJ, et al. Elinzanetant for vasomotor symptoms from endocrine therapy for breast cancer. N Engl J Med. Published online June 2, 2025. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618. Panay N, Joffe H, Maki PM, et al. Efficacy and long-term safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS-3. JAMA Intern Med. 2025;185(11):1319-1327. Contacts Contact for media inquiries: Communications Department Bayer Inc. mediacanada@bayer.com Find more information at

Clinical ResultPhase 3Drug Approval

10 Aug 2026

·firstwordpharma.com

AbCellera's hot flash antibody shows promise for once-monthly dosing

Looking to challenge the daily-dosing standard for non-hormonal treatments of menopause-linked vasomotor symptoms (VMS), AbCellera on Monday shared positive mid-stage data backing its antibody entrant in the space, prompting its stock to jump close to 35% on the news.ABCL635, a long-acting neurokinin-3 receptor (NK-3R) antagonist dosed subcutaneously, met its primary endpoint in the Phase II portion of a Phase I/II trial involving patients with moderate-to-severe VMS, also known as hot flashes.The study enrolled 92 postmenopausal women who were experiencing a mean of 10 hot flashes per day, randomising them to receive either a single 600-mg dose of ABCL635 or placebo.Patients receiving AbCellera's experimental antibody achieved statistically significant reductions in both the frequency and severity of VMS at week 4. The treatment arm experienced, on average, 8.8 fewer moderate and severe events per day from baseline, equal to an 83% reduction in VMS frequency. Those in the placebo group only saw a 33% reduction in VMS frequency — or a 3.5-event reduction per day — for a mean placebo-adjusted treatment difference of 50% (p<0.001).ABCL635 helped tamp down the severity of VMS events as well, achieving a mean 58% reduction of 1.4 points from baseline, compared with a 0.3-point, 12% reduction for placebo. The mean placebo-adjusted treatment difference was 1.1 points, or a 46% reduction (p<0.001). Other secondary measures evaluated ABCL635's impact on sleep and patient-reported scores. According to AbCellera, "meaningful improvements" were seen on scores for both sleep and patient global impression of change (PGI-C).The antibody was well tolerated, with no serious or severe adverse events (AEs), nor any AEs that led to study discontinuation. The most common AEs reported in patients who received a single ABCL635 dose that occurred at a higher rate than the placebo group were headache, fatigue and injection site reaction.Calling the trial results a "significant milestone," Chief Medical Officer Sarah Noonberg said ABCL635 "demonstrated potential best-in-class vasomotor symptom relief over four weeks with a single subcutaneous dose.""These data indicate that ABCL635 could offer menopausal women a well-tolerated, long-acting treatment that has the potential to markedly improve their quality of life," she added.The VMS treatment landscape currently features two non-hormonal options: Bayer's Lynkuet (elinzanetant) and Astellas' Veozah (fezolinetant), both of which are oral drugs dosed once-daily; the former is an NK-1,3R antagonist and the latter blocks NK-3R (see – ViewPoints: Inside Bayer's bet on menopause momentum, and why the health stakes are high and ViewPoints: With incoming rival on horizon, Astellas charts Veozah's voyage to remain market leader).However, hormone therapy recently got a boost for VMS, when the FDA late last year removed boxed warnings for cardiovascular diseases, breast cancer and probable dementia.For more on how physicians are viewing non-hormonal and hormone treatment options for VMS, see Physician Views Results: Doctors likely to stick with hormone therapy habits after FDA's eased warnings, leaving non-hormonal niche intact and Spotlight On: As menopause market gets hormonal again, nonhormonal niche could narrow.

Clinical ResultPhase 2

17 Jul 2026

·allsci.com

Bayer adds Henry Ford Health to expanding US clinical research network

Bayer and Detroit-based Henry Ford Health announced a clinical trials partnership designed to connect more patients with investigational medicines, positioning Henry Ford as one of just four US academic health systems selected for Bayer’s strategic research network. The tie-up spans cardiovascular and renal disease, oncology and women’s health — three areas central to Bayer’s current pipeline — and reflects a broader industry shift toward embedding drug developers directly within health systems that serve large, diverse patient populations. Financial terms were not disclosed, and no specific drug candidate, technology platform or clinical trial identifier was named in the announcement. Under the agreement, Bayer will combine its clinical development capabilities with Henry Ford Health’s trial infrastructure, electronic health record data and patient population to improve trial design, identify eligible participants and generate real-world evidence. The companies also plan to collaborate on data science training. No specific investigational therapies or clinical studies were disclosed. The Henry Ford agreement is the second of its kind for Bayer within two weeks. On July 7, Bayer formed its first-ever academic medical center alliance with the University of Colorado Anschutz, UCHealth and Children’s Hospital Colorado, covering a similar mix of therapeutic areas along with neurodegenerative disease and cell and gene therapy. That deal marked Bayer’s first structured academic health system research network, and the Henry Ford partnership confirms the company is now executing a repeatable model rather than a one-off collaboration. With two of four planned network partners now named, Bayer appears to be assembling a distributed clinical trial infrastructure that spans multiple US regions and patient populations, though the identities of the remaining two systems have not been disclosed. The timing aligns with Bayer’s broader pharmaceutical strategy update from January, in which the company detailed a modality-rich pipeline spanning oncology assets such as darolutamide (Nubeqa) and sevabertinib (Hyrnuo), cardiovascular programs including asundexian and finerenone (Kerendia), and women’s health therapy elinzanetant (Lynkuet). Embedding clinical trial access within large health systems supports patient enrollment for this expanding portfolio, particularly as Bayer pushes multiple Phase III cardiovascular and oncology programs toward regulatory milestones in the coming years. For Henry Ford Health, the Bayer partnership adds to a growing list of external collaborations tied to its research and data capabilities, including its earlier work with BD on pharmacy automation and its role within the Truveta real-world data consortium. The health system’s chief scientific officer, David Lanfear, framed the Bayer collaboration as an effort to reduce participation barriers and accelerate treatment development, while Bayer’s Christoph Koenen pointed to community-embedded research as a way to reach patients where they already receive care. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team. Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Clinical Study

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	Australia	Bayer Australia Ltd.	11 Sep 2025
Hot Flashes	Canada	Bayer, Inc.	01 Jul 2025

Developing

10 top R&D records.

to view more data

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	Bayer AG	20 Nov 2018
Dyssomnias	Phase 2	United States	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	Canada	NeRRe Therapeutics Ltd.	20 Nov 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05099159 (OASIS 2 \| OASIS-2, CTgov)	Phase 3	Vasomotor symptom \| Hot Flashes	400	Elinzanetant (Elinzanetant 120 mg)	uirzjwfulc(nuauiohgiv) = aarliwfhzg nexqemfbtn (npgdmocujl, 11.08) View more	-	12 Feb 2026
				Placebo+Elinzanetant (Placebo - Elinzanetant 120 mg)	uirzjwfulc(nuauiohgiv) = aigaeeotmo nexqemfbtn (npgdmocujl, 11.15) View more
NCT05042362 (OASIS-1 \| OASIS 1, CTgov)	Phase 3	Vasomotor symptom \| Hot Flashes	396	Elinzanetant (Elinzanetant 120 mg)	pxvexoexzl(ejiodymrwv) = vtswgcumpp akljsfvlue (pjdyjfepjf, 6.57) View more	-	12 Feb 2026
				Placebo+Elinzanetant (Placebo - Elinzanetant 120 mg)	pxvexoexzl(ejiodymrwv) = mfkzdjzcsy akljsfvlue (pjdyjfepjf, 13.94) View more
NCT05030584 (OASIS 4 \| OASIS 3 \| OASIS-3, CTgov)	Phase 3	Vasomotor symptom \| Hot Flashes	628	Elinzanetant (BAY3427080) (Elinzanetant (BAY3427080))	uloeppiinz(orwkkntsuz) = izlflhikyk yqsbnpxsuw (rcobctkjkc, 7.15) View more	-	01 Dec 2025
				Placebo (Placebo)	uloeppiinz(orwkkntsuz) = oyxrgjzjlo yqsbnpxsuw (rcobctkjkc, 6.15) View more
NCT05030584 (OASIS-3, Pubmed \| JAMA Intern Med)	Phase 3	Vasomotor symptom	628	Elinzanetant 120 mg	ztywwswlol(seudxctfqu) = numerical advantages for elinzanetant vs placebo for improving VMS frequency and severity swiczprclh (nvvdvfidjq ) View more	Positive	01 Nov 2025
				Placebo
OASIS 1 (Pubmed \| Patient)	Phase 3	Vasomotor symptom	40	Elinzanetant	ojdotdqjzk(qrdopsikxp) = ereymlmjlj vtvlkyigni (vdbvkokosh ) View more	Positive	01 Nov 2025
NCT05587296 (OASIS 4 \| OASIS-4, CTgov)	Phase 3	Hot Flashes \| Vasomotor symptom	474	Elinzanetant (BAY3427080)	dnsjufvzgo(amuzyxivqx) = xhlxxtwevv kojkwdluht (lyghfnoizr, 6.89) View more	-	29 Oct 2025
NCT05099159 \| NCT05042362 (OASIS 1, FDA_CDER) Manual	Phase 3	Vasomotor symptom	796	LYNKUET 120 mg (OASIS 1)	aubjxwlsor(vhbdkbhyph) = iosxmxwofa yulucrlrxk (baxfevnwlv, 0.43) View more	Positive	24 Oct 2025
				Placebo (OASIS 1)	aubjxwlsor(vhbdkbhyph) = gawrxmlqnk yulucrlrxk (baxfevnwlv, 0.43) View more
NCT05587296 (OASIS 4, ASCO2025) Manual	Phase 3	Vasomotor symptom \| Hormone receptor positive breast cancer Adjuvant	-	Elinzanetant 120 mg	movpdvdksv(topacrcyvc) = yjlkpbvnxq zentmintse (rbkgngwbhd, 1.1) View more	Positive	30 May 2025
				Placebo	movpdvdksv(topacrcyvc) = ullxzrejme zentmintse (rbkgngwbhd, 1.2) View more
NCT05030584 (OASIS 4, PipelineReview) Manual	Phase 3	Vasomotor symptom	474	elinzanetant	ewzouvlstl(fsuwllxotz) = 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. shvvfnonzz (nhawwimxwh ) Met View more	Positive	09 Jan 2025
				placebo
NCT05099159 \| NCT05042362 (OASIS 2 \| OASIS 1, Pubmed \| JAMA)	Phase 3	Vasomotor symptom	-	Elinzanetant 120 mg	tzvctryhud(xizbpvsunu) = dabzhmdpmp vmjktfjcjc (jtydnfsjqi, 6.6)	Positive	22 Oct 2024
				Placebo	tzvctryhud(xizbpvsunu) = sppmiatqfd vmjktfjcjc (jtydnfsjqi, 13.9)

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