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A Phase III, Randomised, Open Labelled, Active Controlled, Multi Centre, Superiority Trial of ArTiMist Versus Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications.

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Trial Profile

A Phase III, Randomised, Open Labelled, Active Controlled, Multi Centre, Superiority Trial of ArTiMist Versus Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2023

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At a glance

  • Drugs Artemether (Primary) ; Quinine
  • Indications Falciparum malaria
  • Focus Registrational; Therapeutic Use
  • Sponsors ProtoPharma

Most Recent Events

  • 30 Mar 2021 According to a SUDA media release, the company has placed the ArTiMist program on hold indefinitely. On October 4 2019, company announced it had received notification from the TGA that the initial decision to deny approval of ArTiMist received in May 2019 had been upheld. The primary reason for the decision was that the Delegate was not satisfied that the safety and the efficacy of the product had been satisfactorily established for the purpose for which it is intended for use.
  • 03 Apr 2017 According to a SUDA media release, in late 2016, SUDA made a pre-submission to the TGA and based on that filing the TGA has advised that the filing is complete and deemed the MAA submission to be effective and has accepted the dossier for evaluation. The TGA now has 255 days to complete its review and provide an opinion, including potential approval of the ArTiMist Marketing Authorisation.
  • 30 Apr 2014 New trial record

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