encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe 
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  • ||||||||||  luvadaxistat (NBI-1065844) / Neurocrine, iclepertin (BI425809) / Boehringer Ingelheim, encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Meta-Analysis of Adjunctive Treatment Trials for Cognitive Deficits in Schizophrenia (Griffin Hall) -  Apr 14, 2024 - Abstract #SOBP2024SOBP_413;    
    Overall effect sizes were similar across MoA, suggesting that significance for NMDAR modulators is presumably driven by the larger number of studies. Nevertheless, effect sizes were generally small, suggesting possible ceiling effects or the need for combined behavioral/pharmacological treatments.
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe, bradanicline (ATA-101) / CODA Biotherap
    Journal:  Characterizing the binding of TC-5619 and encenicline on the alpha7 nicotinic acetylcholine receptor using PET imaging in the pig. (Pubmed Central) -  Apr 11, 2024   
    Of particular significance, our in vivo investigations demonstrate that TC-5619 achieves substantial ?7-nAChR occupancy, effectively blocking approximately 40% of ?7-nAChR binding, whereas encenicline exhibits more limited ?7-nAChR occupancy. This study underscores the importance of preclinical PET imaging and target engagement analysis in informing clinical trial strategies, including dosing decisions.
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Preclinical, Journal:  Aged rhesus monkeys: cognitive performance categorizations and preclinical drug testing. (Pubmed Central) -  Dec 16, 2021   
    Accordingly, the older subjects could be categorized as aged "cognitively-unimpaired" or aged "cognitively-impaired" with a third group (aged-other) falling in between. Finally, as a proof of principle, we demonstrated using the DMTP task that aged cognitively-impaired monkeys are sensitive to the pro-cognitive effects of a nicotinic acetylcholine receptor (nAChR) partial agonist, encenicline, suggesting that nAChR ligands remain viable as potential treatments for age-related disorders of cognition.
  • ||||||||||  asenapine / Generic mfg., risperidone / Generic mfg.
    [VIRTUAL] The Perils of Placebo: Developing Medications for Persons with Schizophrenia () -  Apr 13, 2021 - Abstract #ASCP2021ASCP_224;    
    Iloperidone was also approved for schizophrenia based on 2 out of 4 clinical trials, with disagreement between the US Food and Drug Administration and the manufacturer as to which studies were considered ‘positive’ for iloperidone...Be aware of the challenges in studying persons with schizophrenia in placebo-controlled trials 2. Understand some of the ways to increase the probability of differentiating study drug from placebo in clinical trials in persons with schizophrenia
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Journal:  Quantitative assessment of oligomeric amyloid beta peptide binding to alpha7 nicotinic receptor. (Pubmed Central) -  Sep 17, 2020   
    Understand some of the ways to increase the probability of differentiating study drug from placebo in clinical trials in persons with schizophrenia Our TR-FRET Aβ binding assay demonstrates for the first time the specific binding of Aβ to α7nAChR, which will be a crucial tool for the development, testing and selection of a novel generation of AD drug candidates targeting Aβ/α7nAChR complexes with high specificity and lesser side effects compared to currently approved α7nAChR drugs.
  • ||||||||||  dizocilpine (MK801) / Merck (MSD), encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Construct and Face Validity of Mismatch Negativity (MMN) as a Translational Biomarker in Mice (Floridian Ballroom) -  Oct 17, 2019 - Abstract #ACNP2019ACNP_764;    
    We further demonstrated partial, but not full, reversal of the MMN deficits by EVP-6124. This result somewhat reflects the outcome of the clinical trial with schizophrenia patients in which therapeutic efficacy was not obtained.
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Two Global Phase III Trials of Encenicline for Cognitive Impairment in Chronic Schizophrenia Patients: Red Flags and Lessons Learned (Regency R) -  Apr 3, 2019 - Abstract #SIRS2019SIRS_714;    
    These include: 1) the importance of accounting for/mitigating non-adherence to treatment, 2) multiple repeated MCCB testing sessions did not plateau learning effects and 3) subjects with greater change in Outcome scores from screening to baseline also showed aberrant changes from baseline to week 26 compared to subjects with smaller changes prior to baseline, inherently reducing signal:noise ratio. Results of additional post-hoc analyses will be discussed to guide and inform the future development of CIAS clinical trials.
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Enrollment change, Trial termination, Trial primary completion date:  Safety Study of MT-4666 in Subjects With Alzheimer's Disease (clinicaltrials.gov) -  Sep 30, 2015   
    P3,  N=117, Terminated, 
    N=150 --> 0 | Not yet recruiting --> Withdrawn N=200 --> 117 | Recruiting --> Terminated | Trial primary completion date: Jan 2017 --> Oct 2015; This study was terminated due to the benefit-risk balance of MT-4666.
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Trial completion, Trial primary completion date:  Safety and Efficacy of MT-4666 (clinicaltrials.gov) -  Sep 28, 2015   
    P2,  N=450, Completed, 
    N=200 --> 117 | Recruiting --> Terminated | Trial primary completion date: Jan 2017 --> Oct 2015; This study was terminated due to the benefit-risk balance of MT-4666. Active, not recruiting --> Completed | Trial primary completion date: Oct 2015 --> Jun 2015
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Enrollment change, Trial termination, Trial primary completion date:  A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence (clinicaltrials.gov) -  Sep 22, 2015   
    P2,  N=345, Terminated, 
    Active, not recruiting --> Completed | Trial primary completion date: Oct 2015 --> Jun 2015 N=450 --> 345 | Recruiting --> Terminated | Trial primary completion date: Jan 2016 --> Sep 2015; Study has been put on clinical hold by FDA
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Enrollment closed:  Safety and Efficacy of MT-4666 (clinicaltrials.gov) -  Mar 17, 2015   
    P2,  N=450, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Trial completion, Trial primary completion date:  EVP-6124 Hepatic Impairment Study (clinicaltrials.gov) -  Jan 15, 2015   
    P1,  N=34, Completed, 
    Recruiting --> Active, not recruiting Recruiting --> Completed | Trial primary completion date: Mar 2015 --> Dec 2014
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Trial primary completion date:  EVP-6124 Hepatic Impairment Study (clinicaltrials.gov) -  Oct 10, 2014   
    P1,  N=32, Recruiting, 
    Initiation date: Oct 2014 --> Jul 2015 Trial primary completion date: Sep 2014 --> Mar 2015
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    Trial completion:  EVP-6124 Renal Impairment Study (clinicaltrials.gov) -  Feb 26, 2014   
    P1,  N=32, Completed, 
    Not yet recruiting --> Enrolling by invitation Active, not recruiting --> Completed
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    New P1 trial:  EVP-6124 Hepatic Impairment Study (clinicaltrials.gov) -  Nov 13, 2013   
    P1,  N=32, Recruiting, 
  • ||||||||||  encenicline (EVP-6124) / Forum Pharmaceuticals, Mitsubishi Tanabe
    New P1 trial:  EVP-6124 Renal Impairment Study (clinicaltrials.gov) -  Nov 13, 2013   
    P1,  N=32, Completed,