Background and Clinical Need:
Delirium is common at the end of life and is challenging to control. There is a clinical need to study the benefits of commonly used drugs like Haloperidol and Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner.
Aims/Hypotheses:
The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care. The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium.
Methods:
The investigators will conduct a pragmatic, multi-centre, (hospital, inpatient hospice, community hospital) open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium.
The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours post-drug administration.
The secondary outcome is the control of hyperactive delirium at 24, 48 and 72 hours using either Haloperidol or Olanzapine.
The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied.
Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease.
Haloperidol is used traditionally in palliative care for managing delirium. However, as a conventional anti-psychotic, it does cause extra-pyramidal side-effects. Olanzapine, a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium. These 2 commonly used drugs have never been compared head to head in a randomised-controlled, multi-centre study.

Start Date18 May 2022

Sponsor / Collaborator

Tan Tock Seng Hospital Pte Ltd.

NCT01431326 / CompletedNot ApplicableIIT

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Start Date01 Nov 2011

Sponsor / Collaborator

Duke University

[+2]

NCT00124930 / TerminatedPhase 3IIT

A Randomized Double-blind, Parallel Group Study Comparing Olanzapine (Zyprexa) With Haloperidol (Novo-peridol) for the Relief of Nausea and Vomiting in Patients With Advanced Cancer

The purpose of this study is to compare the efficacy and safety of Haldol (haloperidol) and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.

Start Date01 May 2005

Sponsor / Collaborator

Alberta Health Services

[+1]

100 Clinical Results associated with Haloperidol Lactate

100 Translational Medicine associated with Haloperidol Lactate

100 Patents (Medical) associated with Haloperidol Lactate

103

Literatures (Medical) associated with Haloperidol Lactate

11 Jan 2024·Cureus

Severe Clozapine-Induced Agranulocytosis, Pharmacodynamic Synergism, and Lithium Promyelocytic Effects in Granulocyte Colony-Stimulating Factor (G-CSF) Resistance or Delayed Response: A Case Report

Author: Appiah-Kubi, Edmund ; Sarwal, Archna ; Kinfe, Meheret ; Gbinigie, Sarah ; Owusu-Antwi, Philipa

Clozapine-induced agranulocytosis is documented in multiple studies, but there is limited literature on treatment-resistant agranulocytosis, the synergistic effect of multiple agranulocytosis-inducing drugs, and lithium's promyelocytic effects. This case highlights these gaps by discussing a patient with an absolute neutrophil count of zero while being treated with Depakote, Haldol, and clozapine. This case proposes more research on lithium's promyelocytic effects, especially in patients who are unresponsive or have a delayed response to discontinuing offending agents and granulocyte colony-stimulating factor (G-CSF).

12 Sep 2023·AAPS PharmSciTech

Percutaneous absorption and Skin accumulation of Lorazepam-Diphenhydramine- Haloperidol Carbopol gel in Porcine Ear Skin.

Article

Author: Al-Tabakha, Moawia M ; Neupane, Rabin ; Jacob, Shery ; Tiwari, Amit K ; Boddu, Sai H S ; Babu, R Jayachandra

This study presents the formulation and evaluation of an ABH Carbopol gel containing lorazepam (Ativan®), diphenhydramine hydrochloride (Benadryl®), and haloperidol (Haldol®) for treating chemotherapy-induced nausea and vomiting (CINV) in hospice patients. ABH PLO gel is widely used for this purpose due to its low cost and presumed efficacy. However, previous studies, including one conducted by the authors, have reported insufficient drug absorption from the ABH PLO gel. Here we hypothesized that the ABH Carbopol gel would provide superior percutaneous absorption of the drugs. ABH Carbopol gel was characterized for pH, viscosity, thermal properties, and infrared spectroscopy. The percutaneous absorption and skin retention of the gel was evaluated across porcine ear skin using Franz diffusion cells, and the drug concentrations were determined by high-performance liquid chromatography. The pH of the ABH Carbopol gel was found to be 6.80 ± 0.33, and the retention time of diphenhydramine, haloperidol, and lorazepam were 4.73, 7.11, and 18.69 minutes, respectively. The thermogram of the ABH Carbopol gel indicates the drugs were present in the dissolved state. Based on the flux data, the estimated steady-state concentration (C_ss) of diphenhydramine, haloperidol, and lorazepam were found to be 44.64 ng/ml, 2.58 ng/ml, and 20.1 ng/ml, respectively. These values were significantly higher than those obtained from the ABH PLO gel. In conclusion, the ABH Carbopol gel provides a promising alternative to the ABH PLO gel for treating CINV in hospice patients. Further studies are required to validate these findings in clinical settings.

01 Mar 2023·European Journal of Hospital Pharmacy

Visual compatibility and particle counter evaluations of syringes of intramuscular psychotropic coadministered solutions

Article

Author: Djerroud, Lydia ; Sullivan, Thomas ; Dagenais-Beaulé, Vincent ; Leclair, Gregoire

BACKGROUNDPatients in the acute phase of agitation can require the administration of multiple drugs by intramuscular injection in order to temporarily stabilise their condition. Administration of multiple psychotropic medications in a single syringe can be beneficial to both the patient and healthcare professionals. However, there are very little data in the literature regarding psychotropic drug compatibility in syringes for acute agitation.OBJECTIVEThe aim of this study was to assess the visual compatibility of various combinations of 12 intramuscular psychotropic medications in syringes, and to validate compatibility with the use of a particle counter. The medications evaluated were benztropine mesylate, diazepam, dimenhydrinate, diphenhydramine hydrochloride, haloperidol lactate, hydroxyzine, lorazepam, loxapine, methotrimeprazine, midazolam, olanzapine and zuclopenthixol acetate.METHODSCompounded solutions of medication combinations underwent visual inspection initially and after 0.25, 0.5, 1, 2 and 4 hours using a white background and a black background. In order to validate the compatibility results, the presence of particulate matter was determined by light obscuration.RESULTSThis study identified 35 combinations that were visually compatible and 35 that were visually incompatible. We chose eight highly clinically relevant combinations to test using the requirements of the United States Pharmacopoeia (USP) chapter 788 (Particulate Matter in Injections). Of those eight, six were physically compatible, including the triple combinations of lorazepam and haloperidol with either benztropine or diphenhydramine.CONCLUSIONThese physical compatibility results will give healthcare professionals an idea of the possible compatible combinations of psychotropic drugs in syringes, and thus complete some of the missing data in the literature.

News (Medical) associated with Haloperidol Lactate

07 Dec 2022

·www.globenewswire.com

Essential Pharma Announces the Acquisition of HALDOL®

Essential Pharma Announces the Acquisition of HALDOL® HALDOL® is a first-generation ‘typical’ antipsychotic for the treatment of schizophrenia and some other psychiatric conditions The acquisition ensures access to this much-needed antipsychotic for patients and further strengthens Essential Pharma’s portfolio of specialist medicines across key therapeutic areas, particularly in CNS and GI domains Zug, Switzerland – 7 December, 2022 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically well-established pharmaceutical products across key therapeutic areas, announces that it has completed the acquisition of HALDOL® (haloperidol) and HALDOL® Decanoate (haloperidol decanoate) from Janssen Pharmaceutica NV. HALDOL® is a first-generation ‘typical’ antipsychotic for the treatment of schizophrenia and some other psychiatric conditions such as schizoaffective disorder and moderate to severe manic episodes associated with bipolar I disorder. This medicine is included in the World Health Organization’s List of Essential Medicines. Under the terms of the acquisition, Essential Pharma has acquired the rights to HALDOL® on a global basis; the product is currently marketed in the US as well as in more than 60 countries across EMEA, Latin America and the Asia-Pacific regions. The acquisition is a further significant addition to Essential Pharma’s global portfolio of products in specialty central nervous system (CNS)/neurological medicine and underlines the group’s commitment to ensuring the sustained supply of essential medicines to patients. Steen Vangsgaard, CEO of Essential Pharma, commented: “Our aim is to ensure that every patient has access to the mature essential medicines they need. Haloperidol is an essential antipsychotic medicine marketed worldwide. This acquisition means that the patients who rely on this vital medicine can be assured of continued access; it also expands Essential Pharma’s global presence and further strengthens the concentration of our portfolio in CNS.” About Essential Pharma Essential Pharma is an international specialty pharmaceutical group dedicated to maintaining access to well-established, at-risk products essential to patients across multiple therapeutic areas. The group has been an important and valued partner to healthcare providers for over 20 years by giving patients access to medicines that otherwise might not be available. Essential Pharma operates globally in more than 60 countries, supplying a portfolio of over 150 essential medicines across multiple therapeutic areas. Essential Pharma's growth strategy is based on identifying and acquiring mature, at-risk products from larger pharmaceutical groups looking to streamline their product portfolios. It is a trusted partner to multiple pharma companies of all sizes, with a proven history of integrating assets and managing complex technology transfers seamlessly while ensuring continuous and sustainable supply to patients. Essential Pharma's growth strategy is backed by Gyrus Capital, an investment firm dedicated to transformational investments in sectors with long-term sustainable growth, including healthcare. For more information, please visit essentialpharmagroup.com CONTACTS Essential Pharma Steen Vangsgaard, CEO Tel: +44(0)1784 477 167 Email: info@essentialpharmaceuticals.com Consilium Strategic Communications Mary-Jane Elliott / Tracy Cheung / Matthew Cole Tel: +44 (0) 20 3709 5700 Email: Essentialpharma@consilium-comms.com

AcquisitionDrug Approval

03 Nov 2022

·medcitynews.com

Bain Capital-Backed Emalex Bio Lands $250M for Pivotal Test of Tourette Drug

Tourette syndrome causes involuntary muscle and vocal tics that can be treated with several drugs, but most of them work the same way. Emalex Biosciences’ experimental drug hits a different central nervous system target and the biotech has raised $250 million for a Phase 3 clinical trial. The Series D round of financing announced Thursday was led by Bain Capital Life Sciences. The exact cause of Tourette syndrome is unknown but excess activity of a brain chemical called dopamine is thought to play a role. Dopamine receptors have been classified into two families based on their genetic structure: D1 and D2. Currently approved drugs used to treat Tourette—such as the antipsychotic medicines Haldol, Risperdal, Orap—act at the D2 receptor. The Emalex drug, ecopipam, is a small molecule that blocks dopamine at the D1 receptor. The new financing for Chicago-based Emalex follows positive mid-stage clinical trial results for ecopipam. A total of 149 Tourette patients between the ages of 6 and 17 were randomly assigned to receive the study drug or a placebo once daily. After three months, those in the ecopipam group showed an average 30% reduction in score according to a scale used to assess motor and vocal tic severity. By comparison, the placebo group showed an average 19% reduction in score. Side effects reported in the clinical trial included headache, fatigue, sleepiness, insomnia, and anxiety. Depression was also reported and in rare cases, some participants experienced suicidal thoughts. Emalex reported that patients in the trial did not have observable signs of adverse movement or metabolic side effects commonly associated with antipsychotic drugs. Results from the Phase 2 study were presented in March during the annual meeting of the American Academy of Neurology. Startup creator Paragon Biosciences formed Emalex in 2018 to develop new drugs for central nervous system disorders. That year, Emalex acquired Psyadon Pharmaceuticals, which had advanced ecopipam into early Phase 2 testing. The clinical trial results presented earlier this year are from a larger Phase 2 test conducted by Emalex. Ecopipam is Emalex’s only clinical-stage drug candidate. The drug is also in early-stage development as a potential treatment for restless legs syndrome with augmentation, which means that the condition has returned or worsened following treatment with drugs intended to increase low dopamine levels. Emalex said it expects its Phase 3 Tourette study will enroll more than 220 patients across about 90 sites. The other participants in Emalex’s latest financing round include Paragon Biosciences, Valor Equity Partners, Fidelity Management & Research Company, and several family offices.

Small molecular drug

100 Deals associated with Haloperidol Lactate

External Link

KEGG	Wiki	ATC	Drug Bank
D08035	Haloperidol Lactate	N05AD01	DB00502

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Akathisia, Drug-Induced	Phase 1	-	Merck Sharp & Dohme Corp.	15 Aug 2007
Hypersensitivity	Preclinical	ES	ROXALL Medizin GmbH	01 Nov 2012

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

Chat with Hiro

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