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- ||| navacaprant (NMRA-140) / Neumora Therap
Trial completion date: Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder (clinicaltrials.gov) - Mar 31, 2025
P3, N=332, Recruiting, Sponsor: Neumora Therapeutics, Inc.
Trial completion date: May 2025 --> Jun 2026
- ||| navacaprant (NMRA-140) / Neumora Therap
Trial completion date: Study to Assess the Safety and Effectiveness of NMRA-335140-501 (clinicaltrials.gov) - Mar 27, 2025
P3, N=650, Recruiting, Sponsor: Neumora Therapeutics, Inc.
Trial completion date: May 2025 --> Jun 2026 Trial completion date: Sep 2026 --> Jun 2027
- || aticaprant (JNJ-67953964) / J&J, navacaprant (NMRA-140) / Neumora Therap
Preclinical, Review, Journal: Preclinical and clinical efficacy of kappa opioid receptor antagonists for depression: A systematic review. (Pubmed Central) - Aug 10, 2024
Anhedonia is debilitating and insufficiently treated with conventional antidepressants. Future research vistas should establish the efficacy and safety of KORAs in phase 3 studies in both acute and maintenance paradigms.
- | navacaprant (NMRA-140) / Neumora Therap
Journal: Navacaprant, a novel and selective kappa opioid receptor antagonist with no agonist properties implicated in opioid-related abuse. (Pubmed Central) - Jul 21, 2024
100 mg/kg, p.o., whereas morphine (10, 20 mg/kg, i.p.) significantly increased dopamine levels. These results demonstrate that navacaprant is a KOR-selective antagonist with no pharmacological properties implicated in opioid-related abuse.
- |||| navacaprant (NMRA-140) / Neumora Therap
New P2 trial: To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder. (clinicaltrials.gov) - May 28, 2024
P2, N=60, Recruiting, Sponsor: Neumora Therapeutics, Inc.
- navacaprant (NMRA-140) / Neumora Therap
Navacaprant, a Novel Kappa Opioid Receptor Antagonist for Major Depressive Disorder: A Randomized Placebo-Controlled Phase 2 Trial () - Apr 14, 2024 - Abstract #SOBP2024SOBP_934;
Navacaprant was generally safe and well tolerated. These findings support the further development of navacaprant as an antidepressant monotherapy.
- |||||| navacaprant (NMRA-140) / Neumora Therap
Enrollment open: Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder (clinicaltrials.gov) - Jan 2, 2024
P3, N=332, Recruiting, Sponsor: Neumora Therapeutics, Inc.
These findings support the further development of navacaprant as an antidepressant monotherapy. Not yet recruiting --> Recruiting
- |||||| navacaprant (NMRA-140) / Neumora Therap
Enrollment open: Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder (clinicaltrials.gov) - Jan 1, 2024
P3, N=332, Recruiting, Sponsor: Neumora Therapeutics, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| navacaprant (NMRA-140) / Neumora Therap
Trial completion date, Trial initiation date, Trial primary completion date: Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder (clinicaltrials.gov) - Dec 31, 2023
P3, N=332, Not yet recruiting, Sponsor: Neumora Therapeutics, Inc.
- |||| navacaprant (NMRA-140) / Neumora Therap
Trial completion date, Trial primary completion date: Study to Assess the Safety and Effectiveness of NMRA-335140-501 (clinicaltrials.gov) - Dec 31, 2023
P3, N=650, Recruiting, Sponsor: Neumora Therapeutics, Inc.
- |||| navacaprant (NMRA-140) / Neumora Therap
Trial completion date, Trial primary completion date: Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder (clinicaltrials.gov) - Dec 28, 2023
P3, N=332, Recruiting, Sponsor: Neumora Therapeutics, Inc.
- |||||| navacaprant (NMRA-140) / Neumora Therap
Enrollment open: Study to Assess the Safety and Effectiveness of NMRA-335140-501 (clinicaltrials.gov) - Nov 22, 2023
P3, N=650, Recruiting, Sponsor: Neumora Therapeutics, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||| navacaprant (NMRA-140) / Neumora Therap
Enrollment open: Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder (clinicaltrials.gov) - Oct 11, 2023
P3, N=332, Recruiting, Sponsor: Neumora Therapeutics, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| navacaprant (NMRA-140) / Neumora Therap
New P3 trial: Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder (clinicaltrials.gov) - Sep 28, 2023
P3, N=332, Not yet recruiting, Sponsor: Neumora Therapeutics, Inc.
- |||||||||| navacaprant (NMRA-140) / Neumora Therap
New P3 trial: Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder (clinicaltrials.gov) - Sep 28, 2023
P3, N=332, Not yet recruiting, Sponsor: Neumora Therapeutics, Inc.
- | navacaprant (NMRA-140) / Neumora Therap
Journal: Opposing effects on descending control of nociception by mu and kappa opioid receptors in the anterior cingulate cortex. (Pubmed Central) - Sep 19, 2023
Not yet recruiting --> Recruiting ACC kappa opioid receptor activation therefore diminishes descending control of nociception both in na
- |||||||||| navacaprant (NMRA-140) / Neumora Therap
New P3 trial: Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder (clinicaltrials.gov) - Sep 8, 2023
P3, N=332, Not yet recruiting, Sponsor: Neumora Therapeutics, Inc.
- |||||||||| navacaprant (NMRA-140) / Neumora Therap
New P3 trial: Study to Assess the Safety and Effectiveness of NMRA-335140-501 (clinicaltrials.gov) - Sep 8, 2023
P3, N=650, Not yet recruiting, Sponsor: Neumora Therapeutics, Inc.
- NMRA-140 / Neumora Therap
NMRA-140, a Novel and Selective Kappa Opioid Receptor Antagonist: Mode of Action Profiling Studies Demonstrate No Opioid Agonist Properties Implicated in Opioid-Related Abuse (Sapphire AB) - Apr 29, 2023 - Abstract #SOBP2023SOBP_512;
Conclusions NMRA-140 is a KOR-selective antagonist with no agonist activity at MOR, DOR, or KOR. Collectively, these data suggest NMRA-140 has no pharmacological properties implicated in opioid-related abuse.
- | NMRA-140 / Neumora Therap
Journal: Kappa opioid receptor antagonism protects working memory performance from mild stress exposure in Rhesus macaques. (Pubmed Central) - Dec 20, 2022
NMRA-140 protected WM performance from the detrimental effects of FG7142-induced stress and exhibited no significant effect under non-stress conditions. Collectively, these data highlight the functional influence of the KOR system in mediating stress-induced dysfunction of executive processes and suggest that modulating KOR activity could offer therapeutic benefit in stress-related neurobehavioral disorders.
- |||| navacaprant (NMRA-140) / Neumora Therap
Trial completion: Study in Major Depressive Disorder With BTRX-335140 (NMRA-335140) vs Placebo (clinicaltrials.gov) - Sep 10, 2022
P2a, N=204, Completed, Sponsor: BlackThorn Therapeutics, Inc.
Collectively, these data highlight the functional influence of the KOR system in mediating stress-induced dysfunction of executive processes and suggest that modulating KOR activity could offer therapeutic benefit in stress-related neurobehavioral disorders. Active, not recruiting --> Completed
- NMRA-140 / Neumora Therap
Stress, Pain and Reward Interactions and Their Clinical Relevance (713 A) - Jul 19, 2022 - Abstract #IASP2022IASP_598;
However, the potential antidepressant benefits of this and other kappa antagonists such as BTRX 335140 (BlackThorn Therpeutics) are still being realized and investigated and this segment will update the status of this research. New behavioral approaches that aim to reverse fear- and stress-based brain learning will be mentioned in context, recognizing that pharmaceutical interventions may realize their greatest benefit when used to enhance the effects other interventions.
- | NMRA-140 / Neumora Therap
Journal: Chronic pain recruits hypothalamic dynorphin/kappa opioid receptor signalling to promote wakefulness and vigilance. (Pubmed Central) - Apr 30, 2022
Mice with chronic neuropathic pain also showed disrupted NREM and total sleep that was normalized by systemic administration of two structurally different KOR antagonists, norbinaltorphimine (nor-BNI) and NMRA-140, currently in phase II clinical development, or by CRISPR/Cas9 editing of PVN KOR, consistent with endogenous KOR activation disrupting sleep in chronic pain...Notably, while this mechanism is likely beneficial in the short-term, disruption of the homeostatic need for sleep over longer periods may become maladaptive resulting in sustained pain chronicity. A novel approach for treatment of chronic pain may thus result from normalization of chronic pain-related sleep disruption by KOR antagonism.
- || navacaprant (NMRA-140) / Neumora Therap
Enrollment closed: Study in Major Depressive Disorder With BTRX-335140 (NMRA-335140) vs Placebo (clinicaltrials.gov) - Jan 24, 2022
P2a, N=180, Active, not recruiting, Sponsor: BlackThorn Therapeutics, Inc.
A novel approach for treatment of chronic pain may thus result from normalization of chronic pain-related sleep disruption by KOR antagonism. Recruiting --> Active, not recruiting
- || navacaprant (NMRA-140) / Neumora Therap
Trial completion date, Trial primary completion date: Study in Major Depressive Disorder With BTRX-335140 (NMRA-335140) vs Placebo (clinicaltrials.gov) - Oct 5, 2021
P2a, N=180, Recruiting, Sponsor: BlackThorn Therapeutics, Inc.
Recruiting --> Active, not recruiting Trial completion date: Dec 2021 --> Jul 2022 | Trial primary completion date: Dec 2021 --> Jun 2022
- || navacaprant (NMRA-140) / Neumora Therap
Trial completion date, Trial primary completion date: Study in Major Depressive Disorder With BTRX-335140 (NMRA-335140) vs Placebo (clinicaltrials.gov) - Feb 24, 2021
P2a, N=144, Recruiting, Sponsor: BlackThorn Therapeutics, Inc.
Trial completion date: Dec 2021 --> Jul 2022 | Trial primary completion date: Dec 2021 --> Jun 2022 Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- | aticaprant (CERC-501) / J&J, BTRX-140 / BlackThorn Therap
Journal: Differential effects of novel kappa opioid receptor antagonists on dopamine neurons using acute brain slice electrophysiology. (Pubmed Central) - Jan 14, 2021
Collectively, we show electrophysiological evidence of key differences amongst KOR antagonists that could impact their therapeutic potential and have not been observed using recombinant systems. The results of this study demonstrate the value of characterizing compounds in native neuronal tissue and within circuits implicated in the neurobehavioral disorders of interest.
- | BTRX-140 / BlackThorn Therap
Journal: Design and Synthesis of a Novel and Selective Kappa Opioid Receptor (KOR) Antagonist (BTRX-335140). (Pubmed Central) - Mar 4, 2020
CYM-53093 exhibited a broad selectivity over a panel of off-target proteins. This compound is in Phase 1 clinical trials for the treatment of neuropsychiatric disorders wherein dynorphin is thought to contribute to the underlying pathophysiology.
- ||||| BTRX-140 / BlackThorn Therap
Clinical: BlackThorn Therapeutics Advances Phase 2 Clinical Development for Selective KOR Antagonist, BTRX-140, in Neuropsychiatric Disorders https://t.co/98ZXXQtyrq (Twitter) - Jan 23, 2020
- |||| navacaprant (NMRA-140) / Neumora Therap
New P2a trial: Study in Major Depressive Disorder With BTRX-335140 (NMRA-335140) vs Placebo (clinicaltrials.gov) - Jan 7, 2020
P2a, N=120, Recruiting, Sponsor: BlackThorn Therapeutics, Inc.