Trial reportBritish journal of clinical pharmacology2021
Safety, tolerability and pharmacokinetics of emodepside, a potential novel treatment for onchocerciasis (river blindness), in healthy male subjects.
Trial report in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 32 citations in OpenAlex.
- Safety, tolerability and pharmacokinetics of emodepside, a potential novel treatment for onchocerciasis (river blindness), in healthy male subjects.British journal of clinical pharmacology · 2021Trial
- Deep phenotypic profiling uncovers cryptic effects of antifilarial drugs.PLoS pathogens · 2026Article
- Deep phenotypic profiling uncovers cryptic effects of antifilarial drugs.bioRxiv : the preprint server for biology · 2026Article
- Onchocerciasis overview: pathogenesis, clinical spectrum, and therapeutic challenges of a neglected tropical disease.Frontiers in parasitology · 2026Review
- Differential Emodepside Efficacy in Drug-Resistant and Drug-SusceptibleTropical medicine and infectious disease · 2025Article
- Discovery of Human PIM Kinase Inhibitors as a Class of Anthelmintic Drugs to Treat Intestinal Nematode Infections.ACS infectious diseases · 2025Article
- Potential of emodepside for vector-borne disease control.Malaria journal · 2025Article
- Onchocerciasis Drug Discovery: In Vitro Evaluation of FDA-Approved Drugs againstPharmaceutics · 2024Article
- Emodepside: the anthelmintic's mode of action and toxicity.Frontiers in parasitology · 2024Review
- The pipeline for drugs for control and elimination of neglected tropical diseases: 1. Anti-infective drugs for regulatory registration.Parasites & vectors · 2023Review
- Drug development for the treatment of onchocerciasis: Population pharmacokinetic and adverse events modeling of emodepside.PLoS neglected tropical diseases · 2022Article
- Onchocerciasis drug development: from preclinical models to humans.Parasitology research · 2021Review
- A Bidirectional Permeability Assay for beyond Rule of 5 Compounds.Pharmaceutics · 2021Article
- Development of emodepside as a possible adulticidal treatment for human onchocerciasis-The fruit of a successful industrial-academic collaboration.PLoS pathogens · 2021Review
- Emodepside targets SLO-1 channels of Onchocerca ochengi and induces broad anthelmintic effects in a bovine model of onchocerciasis.PLoS pathogens · 2021Article
Corrections and comments
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Authors and funding
13 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsEmodepside is an anthelmintic, originally developed for veterinary use. We investigated in healthy subjects the safety, and pharmacokinetics of a liquid service formulation (LSF) and immediate release (IR) tablet of emodepside in 2 randomised, parallel-group, placebo-controlled, Phase I studies.
methodsSeventy-nine subjects in 10 cohorts in the single ascending dose study and 24 subjects in 3 ascending-dose cohorts in the multiple ascending dose study were enrolled. Emodepside as LSF was administered orally as single 1-40-mg doses and for 10 days as 5 or 10 mg once daily and 10-mg twice daily doses, respectively. Pharmacokinetics and safety were assessed up to 21 and 30 days, respectively. In addition, IR tablets containing 5 or 20 mg emodepside were tested in the single ascending dose study.
resultsEmodepside as LSF was rapidly absorbed under fasting conditions, with dose-proportional increase in plasma concentrations at doses from 1 to 40 mg. Terminal half-life was > 500 hours. In the fed state, emodepside was absorbed more slowly but overall plasma exposure was not significantly affected. Compared to the LSF, the rate and extent of absorption was significantly lower with the tablets.
conclusionsOverall, emodepside had acceptable safety and tolerability profiles, no major safety concerns, after single oral administration of 20 mg as LSF and after multiple oral administration over 10 days at 5 and 10 mg OD and at 10 mg twice daily. For further clinical trials, the development of a tablet formulation overcoming the limitations observed in the present study with the IR tablet formulation is considered.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.