A Placebo Controlled, Double-Blind, 3-Arm Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of 20 mg/kg Oxantel Pamoate in Healthy Adult Volunteers

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of oxantel pamoate tablet after administration of a single and multiple dose in healthy male and female adult volunteers.
The main questions aim to answer if oxantel pamoate is safe and well tolerated in healthy volunteers and if is it absorbed by the human body.
A single dose and a multiple dose of oxantel pamoate will be compared to placebo to see if there are any different effects.

Start Date01 Nov 2024

Sponsor / Collaborator

Swiss Tropical & Public Health Institute

[+2]

NCT03278431 / CompletedPhase 4IIT

Different Drug Combinations Against Hookworm Infection in School-aged Children in the Lao People's Democratic Republic, a Single Blind, Randomised Controlled Trial

More than one billion people are infected with soil-transmitted helminths (STH, A. lumbricoides, hookworm or Trichuris trichiura). Preventive chemotherapy - i.e. annual or biannual treatment of at-risk populations with albendazole or mebendazole is the current strategy against STH. However, the efficacy of both drugs is only moderate against hookworm and low against T. trichiura. For increasing the efficacy and to avoid drug resistance, new drugs or the combination of different drugs is the way forward.
In this randomised controlled trial, we assess the efficacy (based on cure rates) of different drug combinations in school-aged children in Lao. 420 hookworm positive children will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel pamoate-oxantel pamoate treatment arms, 70 with pyrantel pamoate-oxantel pamoate and 70 with mebendazole-pyrantel pamoate-oxantel pamoate. Two stool samples will be collected at baseline and follow-up (14-21 days after treatment) and analysed with Kato-Katz.

Start Date27 Sep 2017

Sponsor / Collaborator

Swiss Tropical & Public Health Institute

ISRCTN14373201 / CompletedNot ApplicableIIT

Efficacy and safety of tribendimidine plus oxantel, tribendimidine plus ivermectin, albendazole plus oxantel pamoate and tribendimidine alone against hookworm and concomitant soil-transmitted helminth infections: a randomised controlled multi-country trial

Start Date25 Jul 2016

Sponsor / Collaborator

Swiss Tropical & Public Health Institute

100 Clinical Results associated with Oxantel Pamoate/Pyrantel Pamoate

100 Translational Medicine associated with Oxantel Pamoate/Pyrantel Pamoate

100 Patents (Medical) associated with Oxantel Pamoate/Pyrantel Pamoate

Literatures (Medical) associated with Oxantel Pamoate/Pyrantel Pamoate

01 Dec 2023·International Journal for Parasitology: Drugs and Drug Resistance

Trichuris muris egg-hatching assay for anthelminthic drug discovery and characterization

Article

Author: Keiser, Jennifer ; Schärer, Anastasia ; Biendl, Stefan

Trichuriasis is a neglected tropical disease widely distributed among tropical and sub-tropical areas and associated with poverty and lack of access to safe drinking water, sanitation and hygiene. Existing drugs have limited efficacy and face a constant risk of developing resistance, necessitating the search for alternative treatments. However, drug discovery efforts are sparse and little research has been performed on anthelminthic effects on embryonated eggs, the infectious life stage of Trichuris spp. We examined bacterial species dependent egg hatching of the murine model parasite Trichuris muris and identified Escherichia coli, Pseudomonas aeruginosa and Enterobacter hormaechei effective as hatching inducers, resulting in hatching yields of 50-70%. Streptococcus salivarius, reported to be associated with reduced drug efficacy of ivermectin-albendazole coadministration in Trichuris trichiura infected patients, did not promote egg hatching in vitro. We optimized hatching conditions using E. coli grown in luria broth or brain-heart infusion media to reach consistently high hatching yields to provide a sensitive, robust and simple egg-hatching assay. Oxantel pamoate demonstrated the strongest potency in preventing hatching, with an EC₅₀ value of 2-4 μM after 24 h, while pyrantel pamoate, levamisole and tribendimidine exhibited only moderate to weak inhibitory effects. Conversely, all tested benzimidazoles and macrolide anthelminthics as well as emodepside failed to prevent hatching (EC₅₀ > 100 μM). Our study demonstrates that egg-hatching assays complement larval and adult stage drug sensitivity assays, to expand knowledge about effects of current anthelminthics on Trichuris spp. Further, the developed T. muris egg-hatching assay provides a simple and cheap screening tool that could potentially lead to the discovery of novel anthelminthic compounds.

04 May 2023·Parasites & vectors

Development of a hookworm egg hatching assay to determine the ovicidal effects of anthelminthics

Article

Author: Easland, Erin ; Keiser, Jennifer ; Biendl, Stefan

Few anthelminthics are currently available, manifesting the urgent need for new treatment options.In vitro profiling of current anthelminthics against larval and adult stage helminths displayed varying effects on closely related worm species and between life stages of the same species.Conversely, limited research has been performed on the egg stage of human hookworms, and the effects of investigational compounds on the egg stage are not routinely assessed.We profiled the development and hatching of Heligmosomoides polygyrus, Ancylostoma duodenale and Necator americanus eggs isolated from rodent faeces in liquid media with various nutrient levels, osmolar concentrations, and acidities in dependence on incubation temperature and light exposure.Incubation conditions were optimized to allow the study of drug effect on immature and embryonated eggs.We analyzed concentration-effect relationships of com. available anthelminthics over 72 h.Rapid embryonation and hatching were observed at room temperature with and without light exposure without nutrient supplementation in a wide range of acidities.Hookworms hatched optimally at room temperature in PBS achieving > 75% hatching over 34 h.Developmental delays were seen when eggs were stored at 4°C with no effect on viability.Similar delays were also seen with increased osmolar concentrations resulting in decreased viability.Benzimidazole anthelminthics effectively reduced the viability and prevented hatching of hookworm eggs, with albendazole and thiabendazole eliciting particularly potent effects at EC50 values below 1μM.Macrolide anthelminthics as well as emodepside, oxantel pamoate, and pyrantel pamoate were inactive while monepantel, levamisole, and tribendimidine displayed varied potencies among the hookworm species.The presented egg-hatching assay will complement ongoing anthelminthic drug discovery and allow a full characterization of drug activity against all life stages.In the development and application of the egg-hatching assay, good accordance was observed between the three hookworm species evaluated.Marketed anthelminthics show differences of drug action compared to larval and adult stages highlighting the importance of profiling drug activity against all life stages.

01 Jun 2021·DrugsQ1 · MEDICINE

Preclinical and Clinical Characteristics of the Trichuricidal Drug Oxantel Pamoate and Clinical Development Plans: A Review

Q1 · MEDICINE

Review

Author: Scandale, Ivan ; Palmeirim, Marta S ; Chabicovsky, Monika ; Keiser, Jennifer ; Gander-Meisterernst, Irene ; Specht, Sabine

Soil-transmitted helminths (Ascaris lumbricoides, hookworm and Trichuris trichiura) infect about one-fifth of the world's population. The currently available drugs are all highly efficacious against A. lumbricoides. However, they are only moderately efficacious against hookworm and poorly efficacious against T. trichiura. Oxantel, a tetrahydropyrimidine derivative discovered in the 1970s, has recently been brought back to our attention given its high efficacy against T. trichiura infections (estimated 76% cure rate and 85% egg reduction rate at a 20 mg/kg dose). This review summarizes the current knowledge on oxantel pamoate and its use against T. trichiura infections in humans. Oxantel pamoate acts locally in the human gastrointestinal tract and binds to the parasite's nicotinic acetylcholine receptor (nAChR), leading to a spastic paralysis of the worm and subsequent expulsion. The drug is metabolically stable, shows low permeability and low systemic bioavailability after oral use. Oxantel pamoate was found to be safe in humans, with only a few mild adverse events reported. Several clinical trials have investigated the efficacy of this drug against T. trichiura and suggest that oxantel pamoate is more efficacious against T. trichiura than the currently recommended drugs, which makes it a strong asset to the depleted drug armamentarium and could help delay or even prevent the development of resistance to existing drugs. We highlight existing data to support the use of oxantel pamoate against T. trichiura infections.

100 Deals associated with Oxantel Pamoate/Pyrantel Pamoate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	P	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Helminthiasis	-	Pfizer Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISRCTN86603231 (Pubmed \| Lancet Infect Dis)	Phase 2	Trichuriasis	480	Oxantel pamoate 5 mg/kg	fovolbbdbu(ankopwuuog) = aroyqdcxji zyovarxcsu (pxvdwkqmqn, 11 - 36)	-	01 Jan 2016
				Oxantel pamoate 25 mg/kg	fovolbbdbu(ankopwuuog) = fmvzkayrrl zyovarxcsu (pxvdwkqmqn, 44 - 65)

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