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1 Trial |  |
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- ||| elinzanetant (NT-814) / Bayer
Trial completion: NIRVANA: A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause (clinicaltrials.gov) - Dec 13, 2024
P2, N=110, Completed, Sponsor: Bayer
Active, not recruiting --> Completed
- || elinzanetant (NT-814) / Bayer
Clinical, Journal: Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. (Pubmed Central) - Aug 22, 2024
P3
Elinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS. ClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159.
- ||| elinzanetant (NT-814) / Bayer
Enrollment closed, Enrollment change: NIRVANA: A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause (clinicaltrials.gov) - Aug 15, 2024
P2, N=110, Active, not recruiting, Sponsor: Bayer
ClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159. Recruiting --> Active, not recruiting | N=78 --> 110
- || elinzanetant (NT-814) / Bayer
Review, Journal: Elinzanetant, a new combined neurokinin-1/-3 receptor antagonist for the treatment of postmenopausal vasomotor symptoms. (Pubmed Central) - Jun 18, 2024
In the SWITCH-1 study, the 120?mg/day and 160?mg/day regimen showed good efficacy for the treatment of vasomotor symptoms and led to significant improvements in quality of life. Thus, 120?mg oral Elinzanetant/day was used in phase III trials, whose results have not yet been published.
- ||| elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women (clinicaltrials.gov) - May 7, 2024
P1, N=64, Completed, Sponsor: Bayer
Thus, 120?mg oral Elinzanetant/day was used in phase III trials, whose results have not yet been published. Active, not recruiting --> Completed
- ||| elinzanetant (NT-814) / Bayer
P3 data, Journal: Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause. (Pubmed Central) - Apr 2, 2024
The OASIS 1 and 2 pivotal phase 3 studies will enable assessment of the efficacy and safety of elinzanetant as a treatment for VMS, together with its effect on sleep disturbances, depressive symptoms, and menopause-related quality of life. Feedback from postmenopausal women with VMS was used to maximize patient centricity in the trials.
- || Veozah (fezolinetant) / Astellas, osanetant (ACER-801) / Sanofi, Zevra Therap, elinzanetant (NT-814) / Bayer
Review, Journal: Systematic review of neurokinin-3 receptor antagonists for the management of vasomotor symptoms of menopause. (Pubmed Central) - Mar 25, 2024
Feedback from postmenopausal women with VMS was used to maximize patient centricity in the trials. Because of the high-quality evidence supporting the efficacy of fezolinetant and elinzanetant, these agents may be an effective option with mild adverse events for women seeking nonhormone treatment of VMS.
- || elinzanetant (NT-814) / Bayer
Enrollment closed: A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women (clinicaltrials.gov) - Feb 29, 2024
P1, N=64, Active, not recruiting, Sponsor: Bayer
Because of the high-quality evidence supporting the efficacy of fezolinetant and elinzanetant, these agents may be an effective option with mild adverse events for women seeking nonhormone treatment of VMS. Recruiting --> Active, not recruiting
- ||||||| elinzanetant (NT-814) / Bayer
Trial completion: OASIS-3: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause (clinicaltrials.gov) - Feb 23, 2024
P3, N=628, Completed, Sponsor: Bayer
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||| elinzanetant (NT-814) / Bayer
New P1 trial: A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women (clinicaltrials.gov) - Jan 23, 2024
P1, N=60, Recruiting, Sponsor: Bayer
- ||| elinzanetant (NT-814) / Bayer
P3 data, Review, Journal: Elinzanetant: a phase III therapy for postmenopausal patients with vasomotor symptoms. (Pubmed Central) - Jan 15, 2024
Elinzanetant is a very promising non-hormonal approach to a highly prevalent symptom constellation, with rapid onset and high efficacy. Wider indications are being explored in current Phase III trials.
- ||||||| elinzanetant (NT-814) / Bayer
Trial completion: OASIS-1: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (clinicaltrials.gov) - Dec 6, 2023
P3, N=396, Completed, Sponsor: Bayer
Wider indications are being explored in current Phase III trials. Active, not recruiting --> Completed
- ||| elinzanetant (NT-814) / Bayer
Enrollment open: NIRVANA: A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause (clinicaltrials.gov) - Nov 28, 2023
P2, N=78, Recruiting, Sponsor: Bayer
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- || Veozah (fezolinetant) / Astellas, Merck (MSD)
Review, Journal: Fezolinetant: A New Nonhormonal Treatment for Vasomotor Symptoms. (Pubmed Central) - Nov 17, 2023
Neurokinin B inhibitors, like fezolinetant, target the physiologic cause of vasomotor symptoms. With the approval of fezolinetant, as well as elinzanetant which is currently in phase 3 clinical trials, providers and patients have additional nonhormonal treatment options for vasomotor symptoms associated with menopause.
- ||||| elinzanetant (NT-814) / Bayer
Enrollment closed: OASIS-4: A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer (clinicaltrials.gov) - Nov 13, 2023
P3, N=405, Active, not recruiting, Sponsor: Bayer
With the approval of fezolinetant, as well as elinzanetant which is currently in phase 3 clinical trials, providers and patients have additional nonhormonal treatment options for vasomotor symptoms associated with menopause. Recruiting --> Active, not recruiting
- |||| elinzanetant (NT-814) / Bayer
New P2 trial: NIRVANA: A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause (clinicaltrials.gov) - Oct 31, 2023
P2, N=78, Not yet recruiting, Sponsor: Bayer
- ||||||| elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) (clinicaltrials.gov) - Oct 23, 2023
P3, N=400, Completed, Sponsor: Bayer
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||| elinzanetant (NT-814) / Bayer
Trial completion date: OASIS-4: A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer (clinicaltrials.gov) - Jul 28, 2023
P3, N=405, Recruiting, Sponsor: Bayer
Active, not recruiting --> Completed Trial completion date: Dec 2024 --> Dec 2026
- ||| elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants (clinicaltrials.gov) - May 9, 2023
P1, N=51, Completed, Sponsor: Bayer
Trial completion date: Dec 2024 --> Dec 2026 Active, not recruiting --> Completed
- ||||| elinzanetant (NT-814) / Bayer
Enrollment closed: OASIS-1: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (clinicaltrials.gov) - Apr 7, 2023
P3, N=370, Active, not recruiting, Sponsor: Bayer
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| elinzanetant (NT-814) / Bayer
Clinical: I think some would like to initiate more trials post breast cancer. But there is not an appetite among most breast oncologists given previous data. It is promising/ hopeful that there are current trials of elinzanetant in breast cancer patients (Twitter) - Apr 5, 2023
- elinzanetant (NT-814) / Bayer
OASIS 4 study design: a Phase 3 trial assessing the efficacy and safety of elinzanetant in the treatment of vasomotor symptoms caused by adjuvant endocrine therapy for breast cancer (Exhibition area) - Mar 22, 2023 - Abstract #ESMOBC2023ESMO_BC_531;
P3
Recruiting --> Active, not recruiting Trial design OASIS 4 (NCT05587296) is an ongoing, multicentre, multicountry, double-blind, randomized, placebo-controlled, phase III study evaluating the efficacy and safety of elinzanetant 120 mg in women aged 18
- || elinzanetant (NT-814) / Bayer
Enrollment closed: A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants (clinicaltrials.gov) - Mar 2, 2023
P1, N=51, Active, not recruiting, Sponsor: Bayer
Trial design OASIS 4 (NCT05587296) is an ongoing, multicentre, multicountry, double-blind, randomized, placebo-controlled, phase III study evaluating the efficacy and safety of elinzanetant 120 mg in women aged 18 Recruiting --> Active, not recruiting
- | elinzanetant (NT-814) / Bayer
Journal: Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). (Pubmed Central) - Feb 27, 2023
Elinzanetant is an effective and well-tolerated nonhormone treatment option for postmenopausal women with VMS and associated sleep disturbance. Elinzanetant also improves quality of life in women with VMS.
- ||||| elinzanetant (NT-814) / Bayer
Enrollment closed: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) (clinicaltrials.gov) - Feb 3, 2023
P3, N=370, Active, not recruiting, Sponsor: Bayer
Elinzanetant also improves quality of life in women with VMS. Recruiting --> Active, not recruiting
- || elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants (clinicaltrials.gov) - Nov 22, 2022
P1, N=20, Completed, Sponsor: Bayer
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||||| elinzanetant (NT-814) / Bayer
Enrollment closed: OASIS-3: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause (clinicaltrials.gov) - Nov 17, 2022
P3, N=508, Active, not recruiting, Sponsor: Bayer
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally (clinicaltrials.gov) - Oct 27, 2022
P1, N=31, Completed, Sponsor: Bayer
Recruiting --> Active, not recruiting Recruiting --> Completed
- |||||||||| elinzanetant (NT-814) / Bayer
New P3 trial: OASIS-4: A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer (clinicaltrials.gov) - Oct 20, 2022
P3, N=405, Recruiting, Sponsor: Bayer
- | elinzanetant (NT-814) / Bayer
Trial completion date, Trial primary completion date: A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally (clinicaltrials.gov) - Sep 19, 2022
P1, N=28, Recruiting, Sponsor: Bayer
Recruiting --> Completed Trial completion date: Aug 2022 --> Nov 2022 | Trial primary completion date: Aug 2022 --> Nov 2022
- || elinzanetant (NT-814) / Bayer
Enrollment closed: A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants (clinicaltrials.gov) - Sep 19, 2022
P1, N=20, Active, not recruiting, Sponsor: Bayer
Trial completion date: Aug 2022 --> Nov 2022 | Trial primary completion date: Aug 2022 --> Nov 2022 Recruiting --> Active, not recruiting
- |||| elinzanetant (NT-814) / Bayer
Trial completion date, Trial primary completion date: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) (clinicaltrials.gov) - Sep 8, 2022
P3, N=370, Recruiting, Sponsor: Bayer
Recruiting --> Active, not recruiting Trial completion date: Jul 2023 --> Oct 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
- |||| elinzanetant (NT-814) / Bayer
Trial completion date, Trial primary completion date: OASIS-1: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (clinicaltrials.gov) - Sep 8, 2022
P3, N=370, Recruiting, Sponsor: Bayer
Trial completion date: Jul 2023 --> Oct 2023 | Trial primary completion date: Mar 2023 --> Jun 2023 Trial completion date: Jul 2023 --> Oct 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
- || elinzanetant (NT-814) / Bayer
Enrollment open: A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants (clinicaltrials.gov) - Sep 1, 2022
P1, N=48, Recruiting, Sponsor: Bayer
Trial completion date: Jul 2023 --> Oct 2023 | Trial primary completion date: Mar 2023 --> Jun 2023 Not yet recruiting --> Recruiting
- || elinzanetant (NT-814) / Bayer
Enrollment open: A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants (clinicaltrials.gov) - Aug 22, 2022
P1, N=20, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| elinzanetant (NT-814) / Bayer
Trial completion date, Trial primary completion date: OASIS-3: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause (clinicaltrials.gov) - Aug 18, 2022
P3, N=600, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Trial completion date: Nov 2023 --> Feb 2024 | Trial primary completion date: Dec 2022 --> Apr 2023
- || elinzanetant (NT-814) / Bayer
New P1 trial: A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants (clinicaltrials.gov) - Aug 1, 2022
P1, N=48, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
New P1 trial: A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants (clinicaltrials.gov) - Jul 25, 2022
P1, N=20, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants (clinicaltrials.gov) - Jul 15, 2022
P1, N=18, Completed, Sponsor: Bayer
Trial completion date: Nov 2023 --> Feb 2024 | Trial primary completion date: Dec 2022 --> Apr 2023 Active, not recruiting --> Completed
- || elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years (clinicaltrials.gov) - Jul 14, 2022
P1, N=16, Completed, Sponsor: Bayer
Active, not recruiting --> Completed Recruiting --> Completed
- || elinzanetant (NT-814) / Bayer
Enrollment open: A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years (clinicaltrials.gov) - Jun 15, 2022
P1, N=16, Recruiting, Sponsor: Bayer
Recruiting --> Completed Not yet recruiting --> Recruiting
- || elinzanetant (NT-814) / Bayer
Enrollment closed: A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants (clinicaltrials.gov) - May 26, 2022
P1, N=18, Active, not recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Not yet recruiting --> Active, not recruiting
- || elinzanetant (NT-814) / Bayer
New P1 trial: A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years (clinicaltrials.gov) - May 18, 2022
P1, N=16, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
New P1 trial: A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants (clinicaltrials.gov) - Apr 28, 2022
P1, N=18, Not yet recruiting, Sponsor: Bayer
- ||| elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults (clinicaltrials.gov) - Mar 24, 2022
P1, N=62, Completed, Sponsor: Bayer
Not yet recruiting --> Active, not recruiting Recruiting --> Completed
- || elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants (clinicaltrials.gov) - Mar 24, 2022
P1, N=33, Completed, Sponsor: Bayer
Recruiting --> Completed Recruiting --> Completed
- || elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years. (clinicaltrials.gov) - Feb 10, 2022
P1, N=16, Completed, Sponsor: Bayer
Recruiting --> Completed Active, not recruiting --> Completed
- || elinzanetant (NT-814) / Bayer
Trial completion date, Trial primary completion date: A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults (clinicaltrials.gov) - Dec 15, 2021
P1, N=52, Recruiting, Sponsor: Bayer
Active, not recruiting --> Completed Trial completion date: Nov 2021 --> May 2022 | Trial primary completion date: Nov 2021 --> May 2022
- || elinzanetant (NT-814) / Bayer
Trial completion, Enrollment change: A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults (clinicaltrials.gov) - Dec 15, 2021
P1, N=14, Completed, Sponsor: Bayer
Trial completion date: Nov 2021 --> May 2022 | Trial primary completion date: Nov 2021 --> May 2022 Recruiting --> Completed | N=20 --> 14
- || elinzanetant (NT-814) / Bayer
Enrollment closed: A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years. (clinicaltrials.gov) - Nov 11, 2021
P1, N=16, Active, not recruiting, Sponsor: Bayer
Recruiting --> Completed | N=20 --> 14 Recruiting --> Active, not recruiting