POC Study of Pipamperone 15mg Added to Stable Risperidone or Paliperidone Treatment in Chronic Schizophrenic and Schizoaffective Patients With Residual Symptoms: a Phase I/IIa, Randomized, Double-blind, Placebo-controlled Trial of 7 Weeks

This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and clinical outcome of chronic schizophrenic patients with residual, so-called 'positive' symptoms, as well as on cognition, motivation, subjective well-being of patients, negative symptoms, general psychopathological symptoms and safety/tolerability.

Start Date01 Mar 2012

Sponsor / Collaborator

PharmaNeuroBoost NV

NL-OMON34843

/ CompletedNot Applicable

A Phase I, open label trial in healthy subjects to evaluate the central nervous receptor occupancy of pipamperone at the 5-HT2A and D2 receptor by means of Positron Emission Tomography. - Pipamperone PET study

Start Date22 Dec 2009

Sponsor / Collaborator

PharmaNeuroBoost NV

EUCTR2006-005313-35-NL

/ Unknown statusNot Applicable

Clinical effects of low dose pipamperon (Dipiperon) versus placebo on cognitive functions of elderly patients suffering from cognitive dysfunction, admitted at a general hospital.

Start Date29 Jan 2008

Sponsor / Collaborator

GGZ Drenthe

100 Clinical Results associated with Pipamperone Hydrochloride

100 Translational Medicine associated with Pipamperone Hydrochloride

100 Patents (Medical) associated with Pipamperone Hydrochloride

430

Literatures (Medical) associated with Pipamperone Hydrochloride

01 Jul 2025·Drug Testing and Analysis

Multianalyte Approach—Including Automated Preparation of Calibrators—for Validated Quantification of 82 Drugs in Whole Blood by Liquid Chromatography–Tandem Mass Spectrometry

Article

Author: Keller, Maja ; Poetzsch, Sandra N. ; Kraemer, Thomas ; Steuer, Andrea E.

ABSTRACT:

Bioanalysis, such as the quantification of drugs in different matrices, is of great importance in forensic toxicology. Nowadays, mainly so‐called multianalyte approaches are used given their increased speed and effectiveness. However, such multianalyte procedures can be difficult to develop and maintain with sufficient robustness in the laboratory. One aspect of this is the tedious, manual preparation of spiking solutions containing such a great number of analytes. Therefore, the current study aimed to develop and validate a fast, simple, and robust liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the quantification of 82 classic drugs and to evaluate an alternative autosampler‐assisted automated approach for the preparation of spiking solutions. Simple protein precipitation of 200‐μL whole blood was used followed by analysis by reversed‐phase LC–MS/MS in advanced scheduled multiple reaction monitoring (MRM) mode. The method was fully validated according to international guidelines, including selectivity, recovery, matrix effects, linearity, bias/imprecision, processed‐sample stability, and limits. Validation criteria were fulfilled for all analytes except for buprenorphine and five benzodiazepines. In the context of a multianalyte procedure, a (multipurpose) autosampler‐assisted automatic preparation of calibrator spiking solutions proved comparable to manual preparation. Thus, automated preparation can overcome the frequently performed manual, time‐consuming, and error‐prone steps of multianalyte approaches and still allow for customized calibration ranges. Since its introduction, more than 8000 cases have been measured with the presented method, and 35 proficiency tests have been passed.

01 Jul 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Sexual dysfunctions associated with antipsychotic drug intake: a retrospective analysis of the FDA adverse events reporting system (FAERS)

Article

Author: Buspavanich, Pichit ; Heinze, Martin ; Engel, Johanna ; Schneider, Michael ; Zolk, Oliver ; Greiner, Timo ; Auerbach, Lilly ; Jeridi, Lamin

Sexual dysfunctions (SD) are common and debilitating side effects of antipsychotics. The current study analyzes the occurrence of antipsychotic-related SD using data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). FAERS was queried for sexual dysfunction adverse events (encoded by 35 different MedDRA preferred terms) secondary to amisulpride, aripiprazole, chlorprothixene, clozapine, haloperidol, loxapine, olanzapine, pipamperone, quetiapine, risperidone, and ziprasidone from 2000 to 2023. Disproportionality signal analysis was performed by calculating the reporting odds ratio (ROR) with its 95% confidence interval (CI). During the observation period, 9203 cases of SD were reported in association with the antipsychotic drug use. Men reported these dysfunctions more frequently (68.4% of all cases) than women. Ziprasidone had the highest ROR for sexual dysfunction in FAERS, at __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__84.86 ; 95 % C I ( 77.50 , 92.94 ) ) , followed by aripirazole for sexual dysfunction __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__( R O R = 34.17 ; 95 % C I ( 32.06 , 36.43 ) ) . In general, aripiprazole, olanzapine, risperidone, ziprasidone, and quetiapine had higher risk signals across multiple adverse events (AEs), whereas chlorprothixene, loxapine, and amisulpride showed lower risk signals. The pathogenesis of SD does not appear to be limited to specific pathomechanisms and therefore not to specific substances. The differing report distributions by sex and the impact of polypharmacy on the symptoms warrant further investigations.

01 Apr 2025·WATER RESEARCH

Towards a better understanding of sorption of persistent and mobile contaminants to activated carbon: Applying data analysis techniques with experimental datasets of limited size

Article

Author: Hofmann, Thilo ; Georgi, Anett ; Lotteraner, Laura ; Saeidi, Navid ; Sigmund, Gabriel ; Mackenzie, Katrin ; Krauss, Martin

The complex sorption mechanisms of carbon adsorbents for the diverse group of persistent, mobile, and potentially toxic contaminants (PMs or PMTs) present significant challenges in understanding and predicting adsorption behavior. While the development of quantitative predictive tools for adsorbent design often relies on extensive training data, there is a notable lack of experimental sorption data for PMs accompanied by detailed sorbent characterization. Rather than focusing on predictive tool development, this study aims to elucidate the underlying mechanisms of sorption by applying data analysis methods to a high-quality dataset. This dataset includes more than 60 isotherms for 22 PM candidates and well-characterized high-surface-area activated carbon (AC) materials. We demonstrate how tools such as distance correlation and clustering can be used effectively to identify the key parameters driving the sorption process. Using these approaches, we found that aromaticity, followed by hydrophobicity, are key sorbate descriptors for sorption, overshadowing steric and charge effects for a given sorbent. Aromatic PMs, although classified as mobile contaminants based on their sorption to soil, are well adsorbed by AC as engineered adsorbent via π-π interactions. Non-aromatic and especially anionic compounds show much greater variability in sorption. The influence of ionic strength and natural organic matter on adsorption was considered. Our approach will help in the analysis of solute-sorption systems and in the development of new adsorbents beyond the specific examples presented here. In order to make the approach accessible, the code is freely available and described on GitHub (https://github.com/Laura-Lotteraner/PM-Sorption), following the FAIR data principles.

News (Medical) associated with Pipamperone Hydrochloride

01 Feb 2024

·www.globenewswire.com

ANeuroTech publishes Phase IIIa data for ANT-01, an adjunctive anti-depression drug, in Personalized Medicine in Psychiatry

ANT-01 is in late-stage development as an adjunctive treatment for major depressive disorder (MDD), with minimal side effects Published data demonstrates substantially better safety profile of ANT-01 than previous serotonin and dopamine antagonists for the treatment of MDD ANeuroTech also files patent application for long-acting prodrugs 31 January 2024: ANeuroTech, a leader in the development of innovative mental health treatments with minimal or no side effects, today announced the publication of Phase IIIa data for ANT-01, its adjunctive anti-depression drug, in the journal of Personalized Medicine in Psychiatry. The Company also filed a Composition of Matter (CoM) patent for the long-acting effects of ANT-01. The Phase IIIa data, published in a paper titled: Low dose pipamperone therapy for major depression: A randomized controlled clinical trial comparison with citalopram, demonstrates that ANT-01 has a substantially better safety profile than previous serotonin and dopamine antagonists used to treat MDD, and that low dose pipamperone has the potential to be an efficacious treatment for MDD as either a monotherapy or in combination with currently available anti-depressants. The paper was co-authored by Erik Buntinx, Lars Bastiaanse, Alan S Schatzberg, Charles B Nemeroff and Philip D Harvey. ANT-01 is a highly selective dopamine and serotonin receptor antagonist and a low dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic developed and marketed at a high dose range for the treatment of psychotic disorders. ANT-01 has been shown to improve cognitive function and anhedonia, something which has not been demonstrated by any other adjunctive antidepressant molecule, with data demonstrating it is more efficient, with an improved safety profile, when compared with currently available adjunctive therapies. ANeuroTech is also developing prodrugs of ANT-01 as a long-acting treatment for MDD. Long-acting treatments remove the need for daily medication, resulting in better patient adherence and a better patient experience. There is currently no long-acting anti-depressant drug available. Dr Erik Buntinx, CEO and Founder of ANeuroTech, commented: “As a psychiatrist, I have seen too often the non-response and problems that come with adjunctive anti-depressant drugs, including a lack of an effective impact on cognitive dysfunctioning and on the loss of the ability to feel pleasure, two key domains in almost all MDD patients with an inadequate response on their initial antidepressant. At ANeuroTech, we are working to bring effective treatments, with minimal or no side-effects, to patients who suffer with depression. The publication in Personalized Medicine in Psychiatry and our patent filing for a long-acting drug are two important milestones in our efforts to meet our goal of finding better ways to help people with MDD.” ANeuroTech, based in Alken, Belgium, is a leader in the development of innovative mental health treatments with minimal or no side effects. The company is in late-stage clinical development of its lead asset, ANT-01, an adjunctive anti-depression drug which has been shown in late-stage clinical trials to improve depression and have a positive impact on cognitive function and anhedonia, with an excellent safety profile. ANT-01 is a low-dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic discovered by the late Dr Paul Janssen and marketed in Europe for the treatment of psychotic disorders. ANeuroTech plans to begin a pivotal Phase IIIb clinical trial of ANT-01 as an adjunctive anti-depression drug for major depressive disorder (MDD) in 2024. ANeuroTech was founded by CEO, Dr Erik Buntinx, an experienced clinician, key opinion leader and global coordinating principal investigator on clinical trials for a number of CNS drugs including Spravato (esketamine). Many of the ANeuroTech team were previously at Johnson & Johnson where they gained extensive experience in the development of treatments for mental and other health disorders. For more information, please visit: https://www.aneurotech.com/ The content above comes from the network. if any infringement, please contact us to modify.

Phase 3Phase 2

05 Jul 2022

·www.biospace.com

Seagen, Anebulo and ANeuroTech Start July with a Bang

Positive clinical data from pharmaceutical companies Seagen and Anebulo were announced Tuesday, along with an announcement of support from the U.S. Food and Drug Administration for ANeuroTech’s innovative new treatment for major depressive disorder (MDD). Seagen’s Touts Positive Phase II Data in Colorectal Cancer Seagen's open-label Phase II MOUNTAINEER trial has produced positive full results. The trial was designed to investigate the safety and efficacy of Tukysa (tucatinib) when administered alongside trastuzumab, in patients with HER2-positive metastatic colorectal cancer (mCRC). The published results represent follow-up data from 84 patients who received the dual treatment. The patients showed a median duration of response at 12.4 months, and a 38.1% confirmed objective response rate. The median progression-free survival duration observed was 8.2 months. “This study has shown the benefits of dual-HER2 inhibition with tucatinib and trastuzumab in patients with HER2-positive metastatic colorectal cancer, including many whose cancer had spread to the liver or lungs before joining the trial,” Roger Dansey, M.D., Seagen’s interim CEO and chief medical officer said. “We believe this chemotherapy-free combination may play an important role in addressing the unmet needs of patients with this disease.” Patients with mCRC currently have limited treatment options. Seagen intends to supplemental New Drug Application for Tukysa to bring a chemotherapy-free option to patients. ANeuroTech’s MDD Drug Receives Positive FDA Feedback ANeuroTech also kicked off July with a bang. The company's Phase IIIb development trial of ANT-01, a drug being developed for MDD, has received positive feedback from the FDA after a pre-investigational new drug (IND) application meeting. The trial will assess the safety and efficicay of ANT-01 combined with a first-line antidepressant versus placebo. Existing treatments for this disorder come with the possibility of a wide range of negative side effects but if ANT-01 reaches the commercial market, patients would have access to a treatment that has little to no side effects. The treatment is a reduced dose of pipamperone dihydrochloride, an antipsychotic that is typically prescribed at a high dose for patients with psychotic conditions. Notably, this trial stands out with a unique secondary endpoint that tracks a participant’s improvement or decline in feelings of pleasure and cognitive function. “ANT-01 has the potential to change the treatment paradigm for the ~190 million patients worldwide with MDD who are not currently helped by initial treatment with antidepressants,” Dr. Rudi Pauwels, executive chairman of ANeuroTech said. An IND application filing for ANT-01 is anticipated in late 2022, and ANeuroTech intends to apply for Fast-Track Designation for the treatment. Anebulo Drug Succeeds in Reversing Acute Cannabinoid Intoxication As the United States moves slowly toward loosening restrictions on the use of cannabinoids, clinical trials investigating potential toxicity levels become more imperative. Anebulo Pharmaceuticals, Inc. is one such company taking an interest in this topic. An ongoing Phase II study is evaluating whether ANEB-001, one of the company’s treatment candidates, might be the answer needed in the event that a patient intakes toxic levels of psychoactive cannabinoids that lead to a condition called acute cannabinoid intoxication (ACI). Positive topline results for this trial were published Tuesday, demonstrating tolerability and efficacy as the treatment reverses feelings of “highness” in patients and a successful primary endpoint measurement. After treatment with 50 mg of ANEB-001, 90% of the patients no longer felt high. After a higher dosage of 100 mg, 70% of patients no longer felt high. These ratios have increased significantly compared to the placebo group, in which only 25% of participants had resolved symptoms of ACI. Additional measurements evaluated central nervous system functions such as alertness and heart rate. The trial is double-blinded and randomized. “The number of individuals with cannabinoid-related intoxication visiting our emergency departments is clearly on the rise,” Dr. Andrew Monte M.D., Ph.D., professor of emergency medicine & medical toxicology at the University of Colorado’s Denver-Anschutz Medical Center said. “Patients are coming from multiple settings including first-time users taking small doses of THC, adults and children inadvertently ingesting powerful THC gummies, and regular users unintentionally overdosing on new and more powerful THC products. Introducing an effective cannabinoid antidote into our treatment options would represent a significant improvement in how we can manage these patients.”

05 Jul 2022

·www.biospace.com

Seagen, ANeuroTech Start July with a Clinical Bang

Scientist working in the laboratory sanjeri/Getty Images Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug. Positive clinical data from pharmaceutical companies Seagen and Anebulo were announced Tuesday, along with an announcement of support from the U.S. Food and Drug Administration for ANeuroTech’s innovative new treatment for major depressive disorder (MDD). Seagen’s Touts Positive Phase II Data in Colorectal Cancer Seagen’s open-label Phase II MOUNTAINEER trial has produced positive full results. The trial was designed to investigate the safety and efficacy of Tukysa (tucatinib) when administered alongside trastuzumab, in patients with HER2-positive metastatic colorectal cancer (mCRC). The published results represent follow-up data from 84 patients who received the dual treatment. The patients showed a median duration of response at 12.4 months, and a 38.1% confirmed objective response rate. The median progression-free survival duration observed was 8.2 months. “This study has shown the benefits of dual-HER2 inhibition with tucatinib and trastuzumab in patients with HER2-positive metastatic colorectal cancer, including many whose cancer had spread to the liver or lungs before joining the trial,” Roger Dansey, M.D., Seagen’s interim CEO and chief medical officer said. “We believe this chemotherapy-free combination may play an important role in addressing the unmet needs of patients with this disease.” Patients with mCRC currently have limited treatment options. Seagen intends to supplemental New Drug Application for Tukysa to bring a chemotherapy-free option to patients. ANeuroTech’s MDD Drug Receives Positive FDA Feedback ANeuroTech also kicked off July with a bang. The company’s Phase IIIb development trial of ANT-01, a drug being developed for MDD, has received positive feedback from the FDA after a pre-investigational new drug (IND) application meeting. The trial will assess the safety and efficicay of ANT-01 combined with a first-line antidepressant versus placebo. Existing treatments for this disorder come with the possibility of a wide range of negative side effects but if ANT-01 reaches the commercial market, patients would have access to a treatment that has little to no side effects. The treatment is a reduced dose of pipamperone dihydrochloride, an antipsychotic that is typically prescribed at a high dose for patients with psychotic conditions. Notably, this trial stands out with a unique secondary endpoint that tracks a participant’s improvement or decline in feelings of pleasure and cognitive function. “ANT-01 has the potential to change the treatment paradigm for the ~190 million patients worldwide with MDD who are not currently helped by initial treatment with antidepressants,” Dr. Rudi Pauwels, executive chairman of ANeuroTech said. An IND application filing for ANT-01 is anticipated in late 2022, and ANeuroTech intends to apply for Fast-Track Designation for the treatment.

Clinical ResultPhase 2Fast TrackPhase 3

100 Deals associated with Pipamperone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01482	Pipamperone Hydrochloride	N05AD05	DB09286

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Schizophrenia	Japan	Alfresa Pharma Corp.	21 Jun 1966
Schizophrenia	Japan	Sannova KK	21 Jun 1966

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis