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Pivotal Phase III study of Piclidenoson

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Trial Profile

Pivotal Phase III study of Piclidenoson

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2025

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At a glance

  • Drugs Piclidenoson (Primary)
  • Indications Plaque psoriasis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms COMFORT-2

Most Recent Events

  • 24 Mar 2025 According to a Can-Fite BioPharma media release, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA, after positive conclusion of the Phase 3 program.
  • 24 Mar 2025 According to a Can-Fite BioPharma media release, the company has initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with USFDA and EMA approved study protocol. Patient enrolment will be initiated in Europe followed by US and Canada.
  • 29 Jan 2024 According to a Can-Fite BioPharma media release, COMFORT 2 trial has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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