 |
8 Diseases |  |
1 Trial |
|
1 Trial |  |
112 News |  |
| «12 |
- |||||| elinzanetant (NT-814) / Bayer
Enrollment open: 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) - Nov 8, 2021
P3, N=370, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting
- || elinzanetant (NT-814) / Bayer
Enrollment open: 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) - Oct 31, 2021
P1, N=20, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| elinzanetant (NT-814) / Bayer
New P3 trial: 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 28, 2021
P3, N=370, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
Enrollment open: 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 24, 2021
P1, N=28, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || elinzanetant (NT-814) / Bayer
Clinical, Journal: Elinzanetant (NT-814), a Neurokinin 1,3 Receptor Antagonist, Reduces Estradiol and Progesterone in Healthy Women. (Pubmed Central) - Oct 22, 2021
NK1,3 receptor antagonism with elinzanetant dose-dependently suppressed the reproductive axis in healthy women, with the 120 mg dose lowering estradiol to potentially ideal levels for UF and EM. As such, elinzanetant may represent a novel therapy to manipulate reproductive hormone levels in women with hormone driven disorders.
- || fezolinetant (ESN364) / Astellas, Merck (MSD), pavinetant (AZD4901) / AstraZeneca, Millendo Therap, elinzanetant (NT-814) / Bayer
Review, Journal: Neurokinin 3 Receptor Antagonists Compared With Serotonin Norepinephrine Reuptake Inhibitors for Non-Hormonal Treatment of Menopausal Hot Flushes: A Systematic Qualitative Review. (Pubmed Central) - Oct 13, 2021
NK3Ras trials show encouraging efficacy and tolerability/safety. Completion of phase 3 NK3Ra trials are required to confirm efficacy and uphold safety/tolerability data but phase 2 results suggest that NK3Ras are more effective than SNRIs for non-hormonal treatment of menopausal HFs.
- || elinzanetant (NT-814) / Bayer
Trial completion: A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants (clinicaltrials.gov) - Oct 12, 2021
P1, N=16, Completed, Sponsor: Bayer
Completion of phase 3 NK3Ra trials are required to confirm efficacy and uphold safety/tolerability data but phase 2 results suggest that NK3Ras are more effective than SNRIs for non-hormonal treatment of menopausal HFs. Active, not recruiting --> Completed
- || elinzanetant (NT-814) / Bayer
New P1 trial: 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 7, 2021
P1, N=28, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
New P1 trial: 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) - Sep 28, 2021
P1, N=20, Not yet recruiting, Sponsor: Bayer
- |||||| elinzanetant (NT-814) / Bayer
Enrollment open: 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) - Sep 16, 2021
P3, N=600, Recruiting, Sponsor: Bayer
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||||| elinzanetant (NT-814) / Bayer
New P3 trial: 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 12, 2021
P3, N=370, Recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
Enrollment open: 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) - Sep 8, 2021
P1, N=16, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| elinzanetant (NT-814) / Bayer
New P3 trial: 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 31, 2021
P3, N=600, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
New P1 trial: 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) - Aug 30, 2021
P1, N=16, Not yet recruiting, Sponsor: Bayer
- ||| elinzanetant (NT-814) / Bayer
Enrollment open: 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) - Aug 25, 2021
P1, N=52, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- elinzanetant (NT-814) / Bayer
[VIRTUAL] Elinzanetant (NT-814): a novel, non-hormonal dual NK-1,3 receptor antagonist for the treatment of vasomotor symptoms – key findings from the Phase 2 SWITCH-1 study (Room 4) - Aug 7, 2021 - Abstract #EMAS2021EMAS_119;
Conclusions Elinzanetant at 120 mg and 160 mg doses showed rapid and sustained reductions in the frequency and severity of VMS and contributed to improvements in women's QoL. Efficacy and safety of elinzanetant will be further evaluated in the Phase 3 program.
- ||| elinzanetant (NT-814) / Bayer
New P1 trial: 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) - Jul 28, 2021
P1, N=52, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
Enrollment closed: A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants (clinicaltrials.gov) - Jul 28, 2021
P1, N=16, Active, not recruiting, Sponsor: Bayer
Efficacy and safety of elinzanetant will be further evaluated in the Phase 3 program. Recruiting --> Active, not recruiting
- || elinzanetant (NT-814) / Bayer
Enrollment open: 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) - Jun 24, 2021
P1, N=32, Recruiting, Sponsor: Bayer
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || elinzanetant (NT-814) / Bayer
Trial completion: Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body (clinicaltrials.gov) - Jun 18, 2021
P1, N=16, Completed, Sponsor: Bayer
Not yet recruiting --> Recruiting Recruiting --> Completed
- || elinzanetant (NT-814) / Bayer
Enrollment open: A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants (clinicaltrials.gov) - Jun 1, 2021
P1, N=16, Recruiting, Sponsor: Bayer
Recruiting --> Completed Not yet recruiting --> Recruiting
- || elinzanetant (NT-814) / Bayer
New P1 trial: 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) - May 26, 2021
P1, N=32, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
Enrollment open: Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body (clinicaltrials.gov) - May 17, 2021
P1, N=20, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || elinzanetant (NT-814) / Bayer
New P1 trial: A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants (clinicaltrials.gov) - May 17, 2021
P1, N=16, Not yet recruiting, Sponsor: Bayer
- || NT-814 / Bayer
Clinical, Journal: Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. (Pubmed Central) - Apr 28, 2021
No safety concerns were identified. Doses up to 300 mg were well tolerated.
- || elinzanetant (NT-814) / Bayer
New P1 trial: Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body (clinicaltrials.gov) - Apr 14, 2021
P1, N=20, Not yet recruiting, Sponsor: Bayer
- || elinzanetant (NT-814) / Bayer
New P1 trial: Mass Balance Study of [14C]-NT-814 Oral Suspension in Healthy Male Subjects (clinicaltrials.gov) - Dec 3, 2020
P1, N=6, Completed, Sponsor: Nerre Therapeutics Ltd.
- | elinzanetant (NT-814) / Bayer
Trial withdrawal: NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study (clinicaltrials.gov) - Aug 8, 2020
P1/2, N=0, Withdrawn, Sponsor: New York State Psychiatric Institute
Doses up to 300 mg were well tolerated. Terminated --> Withdrawn
- ||| elinzanetant (NT-814) / Bayer
Trial completion: SWITCH-1: A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms (clinicaltrials.gov) - Feb 25, 2020
P2, N=199, Completed, Sponsor: Nerre Therapeutics Ltd.
Terminated --> Withdrawn Active, not recruiting --> Completed
- | elinzanetant (NT-814) / Bayer
Enrollment change: NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study (clinicaltrials.gov) - Feb 5, 2020
P1/2, N=4, Terminated, Sponsor: New York State Psychiatric Institute
Active, not recruiting --> Completed N=12 --> 4
- | elinzanetant (NT-814) / Bayer
Trial termination: NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study (clinicaltrials.gov) - Jan 8, 2020
P1/2, N=12, Terminated, Sponsor: New York State Psychiatric Institute
Recruiting --> Terminated; The study was discontinued by the sponsor. No results to report
- | elinzanetant (NT-814) / Bayer
Enrollment closed: SWITCH-1: A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms (clinicaltrials.gov) - Aug 6, 2019
P2, N=165, Active, not recruiting, Sponsor: Nerre Therapeutics Ltd.
No results to report Recruiting --> Active, not recruiting
- || elinzanetant (NT-814) / Bayer
Trial completion date, Trial primary completion date: RELENT-1: Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms (clinicaltrials.gov) - Jan 17, 2019
P1/2, N=80, Completed, Sponsor: Nerre Therapeutics Ltd.
Recruiting --> Active, not recruiting Trial completion date: Oct 2017 --> Mar 2017 | Trial primary completion date: Jul 2017 --> Mar 2017
- ||| elinzanetant (NT-814) / Bayer
Enrollment open: SWITCH-1: A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms (clinicaltrials.gov) - Jan 16, 2019
P2, N=165, Recruiting, Sponsor: Nerre Therapeutics Ltd.
Trial completion date: Oct 2017 --> Mar 2017 | Trial primary completion date: Jul 2017 --> Mar 2017 Not yet recruiting --> Recruiting
- | elinzanetant (NT-814) / Bayer
New P2 trial: SWITCH-1: A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms (clinicaltrials.gov) - Jul 24, 2018
P2, N=165, Not yet recruiting, Sponsor: Nerre Therapeutics Ltd.
- |||| elinzanetant (NT-814) / Bayer
Trial completion: RELENT-1: Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms (clinicaltrials.gov) - Mar 8, 2018
P1/2, N=80, Completed, Sponsor: Nerre Therapeutics Ltd.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||| elinzanetant (NT-814) / Bayer
Enrollment closed: RELENT-1: Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms (clinicaltrials.gov) - Jun 27, 2017
P1/2, N=80, Active, not recruiting, Sponsor: Nerre Therapeutics Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || elinzanetant (NT-814) / Bayer
Trial primary completion date: RELENT-1: Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms (clinicaltrials.gov) - Mar 28, 2017
P1/2, N=80, Recruiting, Sponsor: Nerre Therapeutics Ltd.
Recruiting --> Active, not recruiting Trial primary completion date: Feb 2017 --> Jul 2017
- elinzanetant (NT-814) / Bayer
Enrollment open: NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study (clinicaltrials.gov) - Oct 26, 2016
P1/2, N=12, Recruiting, Sponsor: New York State Psychiatric Institute
Trial primary completion date: Feb 2017 --> Jul 2017 Not yet recruiting --> Recruiting
- | elinzanetant (NT-814) / Bayer
New P1/2 trial: RELENT-1: Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms (clinicaltrials.gov) - Aug 12, 2016
P1/2, N=80, Recruiting, Sponsor: Nerre Therapeutics Ltd.
- elinzanetant (NT-814) / Bayer
New P1/2 trial: NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study (clinicaltrials.gov) - Feb 25, 2016
P1/2, N=12, Not yet recruiting, Sponsor: Sandra D. Comer