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A pivotal study assessing PTG-300

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Trial Profile

A pivotal study assessing PTG-300

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2021

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At a glance

  • Drugs Rusfertide (Primary)
  • Indications Beta-thalassaemia
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 11 Oct 2021 According to a Protagonist Therapeutics media release, the company announced that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the Companys rusfertide clinical studies. Per the FDA, dosing in all clinical studies of rusfertide may be resumed. The Company is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.
  • 17 Sep 2021 According to a Protagonist Therapeutics media release, the U.S. FDA have placed a clinical hold on clinical studies of rusfertide after a non-clinical finding in a 26-week rasH2 transgenic mouse model study, benign and malignant subcutaneous skin tumors were observed in the study. The dosing of patients in all ongoing clinical trials with rusfertide will be put on hold, and study investigators have been contacted to facilitate patient notification.
  • 06 Dec 2019 New trial record

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