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A phase 3 pivotal study of PXL01 for the prevention of patients undergoing tendon repair surgery

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Trial Profile

A phase 3 pivotal study of PXL01 for the prevention of patients undergoing tendon repair surgery

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 Oct 2018

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At a glance

  • Drugs Ensereptide (Primary)
  • Indications Post-surgical adhesions
  • Focus Registrational; Therapeutic Use
  • Sponsors ProMore Pharma

    • Most Recent Events

    • 23 Oct 2018 According to a ProMore Pharma media release, in the Pre-Investigational New Drug Meeting with the FDA, the FDA had no concerns regarding the product concept of using a pre-filled sterile syringe for local administration in connection to the surgery.
    • 23 Oct 2018 According to a ProMore Pharma media release, the company had a Pre-Investigational New Drug Meeting with the FDA to discuss the design of this trial. The desing of the U.S trial is still under discussion and the FDA concluded that the next clinical trial in the U.S. in combination with the results of the clinical Phase III trial in Europe (PHSU03) could be feasible as a basis for a U.S. Market Application.
    • 01 Feb 2018 According to a ProMore Pharma media release, this and another phase 3 trial CTP700276926 will form the basis for market authorization in the US and Canada.
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