Delving into the Latest Updates on Molindone hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Molindone, Molindone XR, Molindone hydrochloride (USP)

+ [7]

Target

D2 receptor

Action

antagonists

Mechanism

D2 receptor antagonists(Dopamine D2 receptor antagonists)

Therapeutic Areas

Nervous System Diseases

Active Indication

Schizophrenia

Inactive Indication

AggressionAttention Deficit Disorder With HyperactivityConduct Disorder

Originator Organization

Strides Pharma Global Pte Ltd.

Active Organization

Epic Pharma LLC

Inactive Organization

Supernus Pharmaceuticals, Inc.CHARTWELL RX SCIENCES LLC

Drug Highest PhaseApproved

First Approval Date

United States (18 Jan 1974),

Schizophrenia

Regulation-

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Structure/Sequence

Molecular FormulaC16H24N2O2

InChIKeyKLPWJLBORRMFGK-UHFFFAOYSA-N

CAS Registry7416-34-4

View All Structures (2)

The purpose of this study is to evaluate the effect of 4-week SPN-810 treatment on brain functioning in patients aged 8-12 years with ADHD and associated feature of impulsive aggression (IA). This will be achieved using functional magnetic resonance imaging (fMRI) in conjunction with the point subtraction aggression paradigm (PSAP) Task, a behavioral aggression paradigm in which subjects are provoked by having money indirectly taken from them by a fictitious opponent, simulating an aggression response.

Start Date30 May 2019

Sponsor / Collaborator

Supernus Pharmaceuticals, Inc.

NCT03597503

/ TerminatedPhase 3

Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

The purpose of this study was to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.

Start Date31 Jul 2018

Sponsor / Collaborator

Supernus Pharmaceuticals, Inc.

NCT02691182

/ TerminatedPhase 3

Open-Label Extension Study to Evaluate the Long-Term Safety of Molindone Hydrochloride Extended-Release Tablets for the Treatment of Impulsive Aggression in Pediatric and Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study were invited to participate in this study. This was a Phase 3 open-label extension (OLE) study to collect long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects were treated with SPN-810. Subjects were given a choice to extend participation in this study every 6 months for up to 36 months.

Start Date01 Apr 2016

Sponsor / Collaborator

Supernus Pharmaceuticals, Inc.

100 Clinical Results associated with Molindone hydrochloride

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100 Translational Medicine associated with Molindone hydrochloride

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100 Patents (Medical) associated with Molindone hydrochloride

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412

Literatures (Medical) associated with Molindone hydrochloride

01 Dec 2024·Science of The Total Environment

Temporal trends and sources of organic micropollutants in wastewater

Article

Author: Christensen, Jan H ; Mortensen, Peter ; Jørgensen, Mathias B ; Tisler, Selina ; Kilpinen, Kristoffer

Effluent wastewater from conventional wastewater treatment plants (WWTPs) is a source of environmental micropollutants. This study investigated temporal trends of organic micropollutants in effluent wastewater, aiming to identify underlying drivers and their implications for treatment efficiency. From September to December 2022, we collected 168 effluent and 10 influent samples. These samples were concentrated using a three-layer solid-phase extraction method and analyzed by liquid chromatography-high resolution mass spectrometry (LC-HRMS). Both targeted and suspect screening approaches were employed, allowing for the full quantification of 64 micropollutants and the identification of 90 additional compounds through suspect screening. Correlations revealed distinct groups of micropollutants with similar temporal trends, indicating common sources or behaviors during treatment. Notably, caffeine and paracetamol showed strong correlations with influent flow rates, indicating their removal efficiency is significantly influenced by hydraulic conditions. PFAS compounds, tire-wear chemicals, and biocides correlated with rain events. Micropollutants were categorized into nine groups based on their temporal trends, linking them to sources and persistence in the WWTP. Industrial discharges significantly contributed to spikes in pharmaceuticals like amitriptyline and citalopram. Metabolite analysis effectively distinguishing between sources of consumption and industrial discharge. These findings underscore the need for regulatory frameworks addressing a broader range of micropollutants. Key events such as rain and industrial discharges impact micropollutant composition and concentrations in effluent wastewater. Our study provides insights into their dynamics within WWTPs, informing improved treatment strategies.

01 Sep 2024·British Journal of Clinical Pharmacology

Assessing the anticholinergic cognitive burden classification of putative anticholinergic drugs using drug properties

Article

Author: Phutietsile, Geofrey Oteng ; Fotaki, Nikoletta ; Nishtala, Prasad S.

AimsThis study evaluated the use of machine learning to leverage drug absorption, distribution, metabolism and excretion (ADME) data together with physicochemical and pharmacological data to develop a novel anticholinergic burden scale and compare its performance to previously published scales.MethodsExperimental and in silico ADME, physicochemical and pharmacological data were collected for antimuscarinic activity, blood–brain barrier penetration, bioavailability, chemical structure and P‐glycoprotein (P‐gp) substrate profile. These five drug properties were used to train an unsupervised model to assign anticholinergic burden scores to drugs. The model performance was evaluated through 10‐fold cross‐validation and compared with the clinical Anticholinergic Cognitive Burden (ACB) scale and nonclinical Anticholinergic Toxicity Scores (ATS) scale, which is based primarily on muscarinic binding affinity.ResultsIn silico software (ADMET Predictor) used for screening drugs for their blood–brain barrier (BBB) penetration correctly identified some drugs that do not cross the BBB. The mean area under the curve for the unsupervised and ACB scale based on the five selected variables was 0.76 and 0.64, respectively. The unsupervised model agreed with the ACB scale on the classification of more than half of the drugs (49 of 88) agreed on the classification of less than half the drugs in the ATS scale (12 of 25).ConclusionsOur findings suggest that the commonly used ACB scale may misclassify certain drugs due to their inability to cross the BBB. By contrast, the ATS scale would misclassify drugs solely depending on muscarinic binding affinity without considering other drug properties. Machine learning models can be trained on these features to build classification models that are easy to update and have greater generalizability.

01 Sep 2024·Psychiatry Research

Dopamine D2 receptor antagonism of antipsychotics and the risk of death due to choking

Article

Author: Luykx, Jurjen J ; Manu, Peter ; Taipale, Heidi ; Hasan, Alkomiet ; Correll, Christoph U ; Lähteenvuo, Markku ; Tiihonen, Jari ; Tanskanen, Antti ; Lieslehto, Johannes

The risk of fatal choking for people with schizophrenia and associations with antipsychotic medication are largely unknown. Therefore, we calculated the choking-related standardized mortality ratio for schizophrenia relative to the general population (SMR_choking). We also computed adjusted hazard ratios (aHR) of choking-related mortality for antipsychotics in a nationwide cohort of patients with schizophrenia (N = 59,916). SMR_choking was 20.5 (95 % confidence interval (CI)=17.1-23.9). The aHR was 1.74 (95 %CI=1.19-2.55) for strong dopamine 2-antagonists. For other antipsychotics, CIs included 1. Importantly, aHRs were particularly high for high dose categories of strong dopamine D2 receptor (D2R) antagonists. In conclusion, a schizophrenia diagnosis is associated with a 20-fold risk of death due to choking. This risk is elevated during use of strong D2R antagonist antipsychotics, particularly when prescribed in high dosages.

100 Deals associated with Molindone hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00796	Molindone hydrochloride	N05AE02	DB01618

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Schizophrenia	United States	Epic Pharma LLC	20 Mar 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aggression	Phase 2	United States	Supernus Pharmaceuticals, Inc.	31 Jul 2018
Attention Deficit Disorder With Hyperactivity	Phase 2	United States	Supernus Pharmaceuticals, Inc.	25 Jan 2016
Attention Deficit Disorder With Hyperactivity	Discovery	United States	Supernus Pharmaceuticals, Inc.	25 Jan 2016
Conduct Disorder	Discovery	United States	Supernus Pharmaceuticals, Inc.	01 Sep 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02691182 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	491	SPN-810 (<18 mg SPN-810)	mwwwsiegmu(qnoarajxfc) = lagghjpvsq hthwqiuytr (kgymjbzbte, egavsatjcd - ntmxmzyhgo) View more	-	16 May 2024
				SPN-810 (18 mg to < 24 mg SPN-810)	mwwwsiegmu(qnoarajxfc) = wwkbzyoqip hthwqiuytr (kgymjbzbte, jeglprrpnz - fzqfbfdgft) View more
NCT02618434 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	297	Placebo (Placebo)	wjhrzqzvoo(chlkieujmm) = ibeiufnerm yweomjonqi (esgupzrncc, dhbifvfhwj - adjolntrul) View more	-	18 Mar 2024
				SPN-810 (36 mg) (High Dose SPN-810 (36 mg))	wjhrzqzvoo(chlkieujmm) = dvbjfiwjdg yweomjonqi (esgupzrncc, oldsboglcl - izabolbmop) View more
NCT03597503 (CTgov)	Phase 3	Aggression \| Attention Deficit Disorder With Hyperactivity	41	Placebo (Placebo)	qhhtqhvvrd(mcgjjqlrfs) = cgqamesltv kuxwgsbejn (sukzcntvib, bpaeqlnfqe - swigbahnld) View more	-	20 Feb 2024
				SPN-810 (Flexible Dose of SPN-810)	qhhtqhvvrd(mcgjjqlrfs) = hfmuseuyyd kuxwgsbejn (sukzcntvib, tjkogzxwtm - wtuftvhlop) View more
NCT02618408 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	333	Placebo (Placebo)	ntqybulusd(wdgkcdlpar) = wntwovujse jqbjcbcfld (ukwvsikksh, zzlfenhsfj - zhomfadkwr) View more	-	01 Nov 2022
				SPN-810 (18 mg) (Low Dose SPN-810 (18 mg))	ntqybulusd(wdgkcdlpar) = pyecmwadth jqbjcbcfld (ukwvsikksh, dwttsjskmv - tplhwlhogp) View more
NCT00053703 (TEOSS, CTgov)	Phase 4	Schizophrenia	116	Olanzapine (enrollment closed in this treatment) (Olanzapine)	itbfbvuqug(dmqjnopghe) = qqkqdeoqoj kyfhpjibkf (rscmpxamke, rlbzfqgfuk - hkqkafurnk) View more	-	26 Mar 2014
				risperidone (Risperidone)	itbfbvuqug(dmqjnopghe) = moskmjswpq kyfhpjibkf (rscmpxamke, bqpqxkqzyn - bunmiulasf) View more