Delving into the Latest Updates on Fasoracetam with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Fasoracetam Monohydrate

+ [10]

Target

mGluRs

Mechanism

mGluRs agonists(Metabotropic glutamate receptor agonists)

Therapeutic Areas

Other DiseasesCardiovascular DiseasesCongenital Disorders+ [3]

Active Indication

Attention Deficit Disorder With Hyperactivity22q11 Deletion Syndrome

Inactive Indication

Anxiety DisordersAutism Spectrum DisorderBrain Diseases+ [2]

Originator Organization

Nippon Shinyaku Co., Ltd.

Active Organization

Nobilis Therapeutics, Inc.Startup

Nippon Shinyaku Co., Ltd.

Inactive Organization

Aevi Genomic Medicine, Inc.

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (US)

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Structure/Sequence

Molecular FormulaC10H16N2O2

InChIKeyGOWRRBABHQUJMX-MRVPVSSYSA-N

CAS Registry110958-19-5

A Multicenter, 2-Part, 6-Week, Double-blind, Randomized, Placebo-controlled, Parallel-design Study to Assess the Efficacy and Safety of AEVI-001 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Implicated in Glutamatergic Signaling and Neuronal Connectivity

This is PART B of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes implicated in glutamatergic signaling and neuronal activity. PART B will assess subjects who do not have CNVs in any of the specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity.

Start Date17 Aug 2018

Sponsor / Collaborator

Aevi Genomic Medicine, Inc.

NCT03265119

/ CompletedPhase 2

A Multicenter, 2-Part, 6-Week, Double-blind, Randomized, Placebo-controlled, Parallel-design Study to Assess the Efficacy and Safety of AEVI-001 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Implicated in Glutamatergic Signaling and Neuronal Connectivity

This is PART A of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes implicated in glutamatergic signaling and neuronal activity. Parts A will include subjects determined to have a specific gene mutations implicated in glutamatergic signaling and neuronal connectivity.

Start Date28 Aug 2017

Sponsor / Collaborator

Aevi Genomic Medicine, Inc.

100 Clinical Results associated with Fasoracetam

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100 Translational Medicine associated with Fasoracetam

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100 Patents (Medical) associated with Fasoracetam

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13

Literatures (Medical) associated with Fasoracetam

01 Mar 2024·3 Biotech

Molecular authentication, metabolite profiling and in silico–in vitro cytotoxicity screening of endophytic Penicillium ramusculum from Withania somnifera for breast cancer therapeutics

Article

Author: Haldar, Niladri ; Rajeshkumar, K C ; Shaikh, Aazam ; Jisha, M S ; Varghese, Sherin ; Gajbhiye, Virendra

In the present study, we isolated a potent endophytic fungus from the roots of Withania somnifera. The endophytic fungal strain was authenticated as Penicillium ramusculum SVWS3 based on morphological and molecular sequencing using four gene data and phylogenetic analyses. In vitro cytotoxicity studies unveiled the remarkable cytotoxic potential of the crude extract derived from P. ramusculum, exhibiting dose-dependent effects on MDA-MB-468 and MCF-7 cells. At a concentration of 100 µg/mL, the crude extract resulted in cell viability of 29.78% for MDA-MB-468 cells and 14.61% for MCF-7 cells. The IC₅₀ values were calculated as 62.83 ± 0.93 µg/mL and 17.23 ± 1.43 µg/mL, respectively for MDA-MB-468 and MCF-7 cells. Caspase activation assay established the underlying mechanism of the crude extract depicting the activation of caspases 3 and 7, indicating the induction of apoptosis in MCF-7 cells. Chemotaxonomic profiling elucidated the ability of P. ramusculum to synthesize a diverse array of bioactive compounds, including Fasoracetam, Tryprostatin B, Odorinol, Thyronine, Brevianamide F, Proglumide, Perlolyrine, Tyrphostin B48, Baptifoline, etc. Molecular docking studies inferred that Baptifoline, Brevianamide F, Odorinol, Perlolyrine, Thyronine, Tryphostin B48, and Tryprostatin B were the lead compounds that could effectively interact with the five selected target receptors of breast cancer, further surpassing the positive controls analyzed. Pharmacokinetic profiling revealed that Baptifoline, Odorinol, and Thyronine depicted an excellent therapeutic profile of druggability. These findings collectively substantiate the anticancer activity of bioactive metabolites synthesized by P. ramusculum SVWS3. Hence, the endophytic P. ramusculum SVWS3 can be an authentic source for developing novel chemotherapeutic drug formulations.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13205-023-03906-3.

03 Jul 2019·Expert Review of NeurotherapeuticsQ3 · MEDICINE

Beyond stimulants: a systematic review of randomised controlled trials assessing novel compounds for ADHD

Q3 · MEDICINE

Review

Author: Cortese, Samuele ; Nageye, Fatuma

Introduction: Despite stimulants being highly efficacious in short-term randomized controlled trials (RCTs), not all patients respond or can successfully tolerate them. A number of novel non-stimulant options are currently in the pipeline for the treatment of attention-deficit/hyperactivity disorder (ADHD). Areas covered: The authors conducted a systematic review of RCTs registered in ClinicalTrials.gov in the past 5 years (January 2014 and February 2019), supplemented by searches in PubMed, Web of Science, and drug manufacturer websites to find recent RCTs on novel non-stimulant ADHD medications. Expert opinion: The authors found 28 pertinent RCTs of compounds acting on a variety of biological targets, including Dasotraline, Viloxazine (SPN-812), Centanafadine SR (CTN SR), OPC-64005, Fasoracetam (NFC-1, AEVI-001), Metadoxine (MDX), Vortioxetine, Tipepidine Hibenzate, Oxytocin, Sativex (delta-9-tetrahydrocannabinol (THC) plus cannabidiol), Mazindol, and Molindone hydrochloride (SPN-810). Given the high effect size found in RCTs of stimulants in terms of efficacy on ADHD core symptoms, it is unlikely that these novel agents will show better efficacy than stimulants, at the group level. However, they may offer comparable or better tolerability. Additionally, agents acting on etiopathophysiological targets disrupted in specific subgroups of patients with ADHD will move forward the pharmacotherapy of ADHD from a 'one size fits all' to a 'precision medicine' approach.

01 May 2017·Journal of Pharmaceutical SciencesQ3 · MEDICINE

A Study of Fasoracetam’s Solid State Forms: A Potential Anti-Alzheimer Pharmaceutical

Q3 · MEDICINE

Article

Author: Harmsen, Bram ; Wouters, Johan ; Robeyns, Koen ; Leyssens, Tom

Different solid state forms of the research chemical fasoracetam, which counters the effects of Alzheimer's disease, have been subjected to a thermal and structural analysis. Single crystals were obtained from solution evaporation and from the melt. Single-crystal X-ray analyses of the crystals show the existence of 2 hydrated and 1 non-hydrated crystalline form of fasoracetam. Under ambient conditions, the hydrate form I is found to be the most stable form, showing a melting point of 57C. This low melting point, combined with possible water losses could cause problems when formulating the hydrated form and impact the storage conditions of the compound.

100 Deals associated with Fasoracetam

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Fasoracetam	-	DB16163

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	Phase 3	-	Nippon Shinyaku Co., Ltd.	-
22q11 Deletion Syndrome	Phase 2	US	Nobilis Therapeutics, Inc.Startup	10 Feb 2022
22q11 Deletion Syndrome	Phase 2	CA	Nobilis Therapeutics, Inc.Startup	10 Feb 2022
Depressive Disorder, Major	Phase 2	JP	-	-
Anxiety Disorders	Discovery	US	Aevi Genomic Medicine, Inc.	28 Nov 2016
Autism Spectrum Disorder	Discovery	US	Aevi Genomic Medicine, Inc.	28 Nov 2016
Brain Diseases	Discovery	US	Aevi Genomic Medicine, Inc.	28 Nov 2016
DiGeorge Syndrome	Discovery	US	Aevi Genomic Medicine, Inc.	28 Nov 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03265119 (CTgov)	Phase 2	Attention Deficit Disorder With Hyperactivity	69	AEVI-001 (AEVI-001)	ghmbetqocb(tirnejuzvl) = tcncthlijb tgnomjiyct (rnsxfibqzy, cmijwwyxty - nanxpazmxu) View more	-	16 Jul 2019
				Placebo (Placebo)	ghmbetqocb(tirnejuzvl) = tqsbqkmaxz tgnomjiyct (rnsxfibqzy, ptvmgxvanq - lfwepiygky) View more
NCT03609619 (CTgov)	Phase 2	Attention Deficit Disorder With Hyperactivity	109	AEVI-001 (AEVI-001)	lgxlbwepqz(qvigmaqeya) = cdutmjvmme tphntbxugs (aeqdtvocda, gauqfuswtd - bzaylnpqhx) View more	-	16 Jul 2019
				Placebo (Placebo)	lgxlbwepqz(qvigmaqeya) = jmfdvjlskj tphntbxugs (aeqdtvocda, rfmumcwyzp - fybdkqjlhi) View more
NCT02777931 (CTgov)	Phase 2/3	Attention Deficit Disorder With Hyperactivity	101	NFC-1 (NFC-1)	etaevvbjsm(jgbpapxmua) = lvsbolttrn jcpilmhujn (vfylibxcxk, qtebfooido - hgkquwzzuf) View more	-	29 Mar 2018
				Placebo (Placebo)	etaevvbjsm(jgbpapxmua) = qanvswlqdy jcpilmhujn (vfylibxcxk, khizqqixgf - neqchidevg) View more