- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Enrollment closed, Enrollment change: Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (clinicaltrials.gov) - Oct 10, 2024 P3, N=183, Active, not recruiting, Recruiting --> Active, not recruiting | N=750 --> 241 Recruiting --> Active, not recruiting | N=750 --> 183
- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia (clinicaltrials.gov) - Jun 22, 2023 P2/3, N=136, Terminated, Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2024 --> Dec 2023 N=370 --> 136 | Trial completion date: Nov 2024 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2024 --> May 2023; Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility.
- |||||||||| Review, Journal: Promising candidates from drug clinical trials: Implications for clinical treatment of Alzheimer's disease in China. (Pubmed Central) - Dec 3, 2022
The reuse of drugs or combinations currently under investigation for the psychiatric treatment of Alzheimer's disease, including AXS-05, AVP-786, nabilone, brexpiprazole, methylphenidate, and pimavanserin, could provide physicians with additional treatment options. Although most of these drugs have not been explored in China yet, due to the current development trend in this field in China, it is expected that China will be involved in research on these drugs in the future.
- |||||||||| Journal: Clinical Application and Synthesis Methods of Deuterated Drugs. (Pubmed Central) - Nov 24, 2022
In 2017, austedo was approved by the FDA as a new drug for Huntington's disease in the United States, the first deuterium drug to be marketed worldwide...In addition, BMS-986165, RT001, ALK-001, HC-1119, AVP-786 and other drugs are in phase Ⅲ clinical studies, and some solid deuterium compounds have entered phase I and Ⅱclinical trials...In this paper, the research and development of deuterated drugs are reviewed, and the influence of deuterium modification on drugs, the advantages of deuterium strategies and the synthesis strategies of deuterated drugs are mainly introduced. Hoping to provide references for clinical application, the discovery of new deuterium chemical entities and research and development of new deuterated drugs.
- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Trial completion: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury (clinicaltrials.gov) - Oct 18, 2022 P2, N=168, Completed, Hoping to provide references for clinical application, the discovery of new deuterium chemical entities and research and development of new deuterated drugs. Active, not recruiting --> Completed
- |||||||||| Review: Investigational Drugs for the Treatment of Depression (Part 2): Glutamatergic, Cholinergic, Sestrin Modulators, and Other Agents. (Pubmed Central) - Jul 20, 2022
Sestrin modulators, cholinergic receptor modulators, or onabotulinumtoxinA have also been investigated for potential antidepressant activity. In conclusion, there is hope for new treatments in uni- and bipolar depression, as it became clear, after almost 7 decades of monoamine-modulating antidepressants, that new pathogenetic pathways should be targeted to increase the response rate in this population.
- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Trial completion date, Trial primary completion date: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia (clinicaltrials.gov) - Jul 12, 2022 P2/3, N=370, Recruiting, In conclusion, there is hope for new treatments in uni- and bipolar depression, as it became clear, after almost 7 decades of monoamine-modulating antidepressants, that new pathogenetic pathways should be targeted to increase the response rate in this population. Trial completion date: Aug 2022 --> Nov 2024 | Trial primary completion date: Jul 2022 --> Oct 2024
- |||||||||| Review, Journal: Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status. (Pubmed Central) - Jan 7, 2022
Furthermore, to date, most have demonstrated relatively modest effects compared with (R,S)-ketamine and esketamine, though some have shown more favorable characteristics. Of these novel agents, the most promising, and the ones for which the most evidence exists, appear to be those targeting ionotropic glutamate receptors.
- |||||||||| dextromethorphan deuterated/quinidine ultra-low dose (AVP-786) / Otsuka, ANAVEX 3-71 / Anavex, edonerpic (T-817MA) / Fujifilm Holdings
Journal: The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer's. (Pubmed Central) - Dec 16, 2021 AF710B, T-817 MA, and ANAVEX2-73 are some of the σ-1R agonists which have shown promising results and have entered clinical trials...The future of AD treatment could involve the combined targeting the σ-1R and autophagy activation. We suggest that future studies investigate the link between autophagy the σ-1R and AD.
- |||||||||| ganaxolone oral (CCD-1042) / Marinus
Review, Journal: Emerging Therapeutics Based on the Amino Acid Neurotransmitter System: An Update on the Pharmaceutical Pipeline for Mood Disorders. (Pubmed Central) - Jun 16, 2021 We cover both glutamate-targeting drugs such as: esketamine, AVP-786, REL-1017, AXS-05, rapastinel (GLYX-13), AV-101, NRX-101; as well as GABA-targeting drugs such as: brexanolone (SAGE-547), ganaxolone, zuranolone (SAGE-217), and PRAX-114. We focus the review on phase-II and phase-III clinical trials and evaluate the extant data and progress of these compounds.
- |||||||||| dextromethorphan deuterated/quinidine ultra-low dose (AVP-786) / Otsuka
Journal: AVP-786 as a promising treatment option for Alzheimer's Disease including agitation. (Pubmed Central) - Feb 23, 2021 Future phase III studies should use innovative study designs such as the Sequential Parallel Comparison Design to mitigate high placebo response, and the Cohen-Mansfield Agitation Inventory for agitation assessment. They should also include positron emission tomography studies to assess occupancy of various receptors in the brain after AVP-786 is administered.
- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Enrollment open, Trial completion date, Trial primary completion date: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury (clinicaltrials.gov) - Aug 8, 2020 P2, N=150, Recruiting, N=412 --> 550 Active, not recruiting --> Recruiting | Trial completion date: Jun 2020 --> Oct 2022 | Trial primary completion date: Jun 2020 --> Oct 2022
- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Enrollment closed: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury (clinicaltrials.gov) - Apr 24, 2020 P2, N=150, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| ganaxolone oral (CCD-1042) / Marinus
Review, Journal: A new generation of antidepressants: an update on the pharmaceutical pipeline for novel and rapid-acting therapeutics in mood disorders based on glutamate/GABA neurotransmitter systems. (Pubmed Central) - Aug 3, 2019 Here, we review progress in the development of compounds that act on these systems as well as their purported mechanisms of action. We include glutamate-targeting drugs, such as racemic ketamine, esketamine, lanicemine (AZD6765), traxoprodil (CP-101,606), EVT-101, rislenemdaz (CERC-301/MK-0657), AVP-786, AXS-05, rapastinel (formerly GLYX-13), apimostinel (NRX-1074/AGN-241660), AV-101, NRX-101, basimglurant (RO4917523), decoglurant (RG-1578/RO4995819), tulrampator (CX-1632/S-47445), and riluzole; and GABA-targeting agents, such as brexanolone (SAGE-547), ganaxolone, and SAGE-217.
- |||||||||| Journal: Glutamatergic Modulators in Depression. (Pubmed Central) - Jun 7, 2019
These results have prompted the repurposing or development of other glutamatergic modulators, both as monotherapy or adjunctive to other therapies. Here, we highlight the evidence supporting the antidepressant effects of various glutamatergic modulators, including (1) broad glutamatergic modulators (ketamine, esketamine, dextromethorphan, dextromethorphan-quinidine [Nuedexta], AVP-786, nitrous oxide [N2O], AZD6765), (2) subunit (NR2B)-specific N-methyl-D-aspartate (NMDA) receptor antagonists (CP-101,606/traxoprodil, MK-0657 [CERC-301]), (3) glycine-site partial agonists (D-cycloserine, GLYX-13, sarcosine, AV-101), and (4) metabotropic glutamate receptor modulators (AZD2066, RO4917523/basimglurant, JNJ40411813/ADX71149, R04995819 [RG1578]).
- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Enrollment closed, Trial primary completion date: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type (clinicaltrials.gov) - May 23, 2019 P3, N=522, Active, not recruiting, Here, we highlight the evidence supporting the antidepressant effects of various glutamatergic modulators, including (1) broad glutamatergic modulators (ketamine, esketamine, dextromethorphan, dextromethorphan-quinidine [Nuedexta], AVP-786, nitrous oxide [N2O], AZD6765), (2) subunit (NR2B)-specific N-methyl-D-aspartate (NMDA) receptor antagonists (CP-101,606/traxoprodil, MK-0657 [CERC-301]), (3) glycine-site partial agonists (D-cycloserine, GLYX-13, sarcosine, AV-101), and (4) metabotropic glutamate receptor modulators (AZD2066, RO4917523/basimglurant, JNJ40411813/ADX71149, R04995819 [RG1578]). Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2019 --> Sep 2019
- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Trial completion date, Trial termination, Trial primary completion date: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder (clinicaltrials.gov) - Jan 31, 2019 P2, N=10, Terminated, Trial completion date: Mar 2021 --> Jun 2022 | Trial primary completion date: Mar 2021 --> Jun 2022 Trial completion date: Sep 2020 --> Dec 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2020 --> Dec 2018; Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.
- |||||||||| deudextromethorphan/quinidine ultra-low dose (AVP-786) / Otsuka
Enrollment closed, Enrollment change: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder (clinicaltrials.gov) - Oct 31, 2018 P2, N=10, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=150 --> 10
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