- |||||||||| basimglurant (NOE-101) / Noema Pharma
Trial completion date, Trial primary completion date: Basimglurant in Children, Adolescents, and Young Adults With TSC (clinicaltrials.gov) - Mar 6, 2024 P2, N=54, Recruiting, Trial completion date: Aug 2025 --> Jan 2026 | Trial primary completion date: Mar 2024 --> Nov 2024
- |||||||||| basimglurant (NOE-101) / Noema Pharma
Repositioning of Basimglurant (mGluR5 Antagonist) for the Treatment of Idiopathic Pulmonary Fibrosis (San Diego Convention Center, Area E (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_2159; mGluR5 antagonists are already proven to be safe and well tolerated in patients. Thus, the current preclinical validation could rapidly expedite the translation of the existing mGluR5 antagonists for IPF and other indications of interstitial lung diseases.
- |||||||||| gemlapodect (NOE-105) / Noema Pharma
Phase classification: A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus) (clinicaltrials.gov) - Dec 7, 2023 P2, N=67, Active, not recruiting, Thus, the current preclinical validation could rapidly expedite the translation of the existing mGluR5 antagonists for IPF and other indications of interstitial lung diseases. Phase classification: P2b --> P2
- |||||||||| ecopipam (PSYRX 101) / Paragon Biosci, gemlapodect (NOE-105) / Noema Pharma
A Validated Rating Scale to Accurately Determine the Treatment Effects in Childhood Onset Fluency Disorder (Stuttering)--the MLGSS. (Salon 4) - May 9, 2023 - Abstract #ASCP2023ASCP_410; A commonly used scale in stuttering assessment, the OASES, (secondary endpoint in the Ecopipam trials) although subject rated, is not reliable to measure treatment effects over time given its lengthy nature (100 questions for the adult version--subject rater fatigue.) A more compact subjective measure, the SSS, also a secondary endpoint in the above trials, yielded more reliable results than the above scales but it too is limited by several factors including that the items are unstructured and not standardized as to the time (e.g. "today's session" vs. "last week.") To overcome our unmet medical need in developing viable treatments for our stuttering community, Maguire, Leal and Garibaldi created the MLGSS (Maguire, Garibaldi, Leal Stuttering Scale), a 10 item, subject rated assessment of their own stuttering and its impact over the prior week...A further validation study of the ability of the MLGSS to measure treatment effects over time is currently being conducted in the Orpheus study which is a trial of gemlapodenct (NOE-105), a PDE-10A inhibitor, in a double-blind placebo-controlled, multicenter Phase II trial for the treatment in COFD (stuttering.) Learning Objectives 1...2. Summarize the challenges in reliably assessing stuttering severity over time.
- |||||||||| basimglurant (NOE-101) / Noema Pharma
Trial primary completion date: Basimglurant in Children, Adolescents, and Young Adults With TSC (clinicaltrials.gov) - Apr 10, 2023 P2b, N=54, Recruiting, Summarize the challenges in reliably assessing stuttering severity over time. Trial primary completion date: Nov 2023 --> Mar 2024
- |||||||||| basimglurant (NOE-101) / Noema Pharma
Trial completion date, Trial primary completion date: Basimglurant in Children, Adolescents, and Young Adults With TSC (clinicaltrials.gov) - Nov 29, 2022 P2b, N=54, Recruiting, Trial completion date: May 2024 --> Aug 2024 Trial completion date: Jul 2024 --> Aug 2025 | Trial primary completion date: Jun 2024 --> Nov 2023
- |||||||||| Journal: Clinical investigations of compounds targeting metabotropic glutamate receptors. (Pubmed Central) - Sep 14, 2022
Antagonists of mGlu2/3Rs (decoglurant and TS-161) have been studied in depression where TS-161 has advanced into a planned Phase 2 study in treatment-resistant depression...The mGlu4R potentiator, foliglurax, did not meet its primary endpoint in patients with Parkinson's disease. Ongoing efforts to develop mGluR-targeted compounds continue to promise these glutamate modulators as medicines for psychiatric and neurological disorders.
- |||||||||| basimglurant (NOE-101) / Noema Pharma
Trial completion date, Trial initiation date: Basimglurant in Children, Adolescents, and Young Adults With TSC (clinicaltrials.gov) - May 5, 2022 P2b, N=55, Recruiting, Ongoing efforts to develop mGluR-targeted compounds continue to promise these glutamate modulators as medicines for psychiatric and neurological disorders. Trial completion date: Apr 2024 --> Jul 2024 | Initiation date: May 2022 --> Mar 2021
- |||||||||| basimglurant (NOE-101) / Noema Pharma
Enrollment open, Trial completion date, Trial primary completion date: Basimglurant in Children, Adolescents, and Young Adults With TSC (clinicaltrials.gov) - Feb 28, 2022 P2b, N=55, Recruiting, Trial completion date: Apr 2024 --> Jul 2024 | Initiation date: May 2022 --> Mar 2021 Not yet recruiting --> Recruiting | Trial completion date: May 2023 --> Apr 2024 | Trial primary completion date: May 2023 --> Apr 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.
- |||||||||| ketamine / Generic mfg., atomoxetine / Generic mfg., memantine / Generic mfg.
Clinical, Review, Journal: Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. (Pubmed Central) - Nov 29, 2021 The evidence for use of the remaining glutamate receptor modulators is limited as very few trials were included in the meta-analyses for each comparison and the majority of comparisons included only one study. Long term non-inferiority RCTs comparing repeated ketamine and esketamine, and rigorous real-world monitoring are needed to establish comprehensive data on safety and efficacy.
- |||||||||| RG7203 / Roche
Clinical, Journal: Deep Learning-Based Human Activity Recognition for Continuous Activity and Gesture Monitoring for Schizophrenia Patients With Negative Symptoms. (Pubmed Central) - Nov 18, 2020 P1 Data were analyzed in a randomized, three-way cross-over, proof-of-mechanism study (ClinicalTrials.gov: NCT02824055) comparing two doses of RG7203 with placebo, given as adjunct to stable antipsychotic treatment in patients with chronic schizophrenia and moderate levels of negative symptoms...Activity measures showed similar correlations with PANSS negative symptom factor but did not reach significance. Our findings support the use of wrist-worn devices to derive activity and gesture-based digital outcome measures for patients with schizophrenia with negative symptoms in a clinical trial setting.
- |||||||||| 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]).
- |||||||||| dizocilpine (MK801) / Merck (MSD), basimglurant (RG7090) / Roche, ADX 47273 / Addex
Journal: Bidirectional variation in glutamate efflux in the medial prefrontal cortex induced by selective positive and negative allosteric mGluR5 modulators. (Pubmed Central) - Apr 28, 2019 The effect of MK801 (0.03-0.06 mg/kg, s.c.) on mPFC glutamate efflux was also investigated in addition to the effects of MK801 (0.03 mg/kg, s.c.) following ADX47273 (100 mg/kg, p.o.) pre-treatment...These findings indicate that positive and negative allosteric mGluR5 modulators produce long lasting and opposing actions on extracellular glutamate efflux in the mPFC. Positive and negative allosteric modulators of mGluR5 may therefore be viable therapeutic agents to correct abnormalities in glutamatergic signalling present in a range of neuropsychiatric disorders.
- |||||||||| basimglurant (NOE-101) / Noema Pharma
Enrollment change: A Study of RO4917523 in Patients With Treatment Resistant Depression (clinicaltrials.gov) - Aug 31, 2016 P2, N=46, Completed, Positive and negative allosteric modulators of mGluR5 may therefore be viable therapeutic agents to correct abnormalities in glutamatergic signalling present in a range of neuropsychiatric disorders. N=34 --> 46
- |||||||||| basimglurant (NOE-101) / Noema Pharma
Enrollment closed, Enrollment change: A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD) (clinicaltrials.gov) - Aug 3, 2015 P1, N=23, Active, not recruiting, Active, not recruiting --> Recruiting | N=23 --> 60 Recruiting --> Active, not recruiting | N=60 --> 23
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