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An Open-label Study of the Pharmacokinetics and Safety of a Single Dose of Moxidectin Per Oral in Subjects Aged 4 to 17 Years With (or at Risk of) Onchocerciasis to Identify an Optimal Dose for Treatment of Children 4 to 11 Years

Trial Profile

An Open-label Study of the Pharmacokinetics and Safety of a Single Dose of Moxidectin Per Oral in Subjects Aged 4 to 17 Years With (or at Risk of) Onchocerciasis to Identify an Optimal Dose for Treatment of Children 4 to 11 Years

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs Moxidectin (Primary)
  • Indications Onchocerciasis
  • Focus Pharmacokinetics
  • Sponsors Medicines Development Limited

Most Recent Events

  • 20 Feb 2025 According to Medicines Development for Global Health media release, based on results from this trial the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for moxidectin 2mg tablets for the treatment of river blindness (onchocerciasis) in children aged four years and older and weighing at least 13 kg.
  • 13 Dec 2022 Status changed from active, no longer recruiting to completed.
  • 22 May 2022 Status changed from recruiting to active, no longer recruiting.

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