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A pivotal Phase 2/3 trial of RGLS-8429

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A pivotal Phase 2/3 trial of RGLS-8429

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 09 Feb 2025

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At a glance

  • Drugs Farabursen (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Adverse reactions; Registrational; Therapeutic Use

Most Recent Events

  • 29 Jan 2025 According to a Regulus Therapeutics media release, Successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) with agreement on key components of a Phase 3 single pivotal trial for potential Accelerated Approval.
  • 24 Jun 2024 According to a Regulus Therapeutics media release, data from phase 1b MAD study will form the basis for a potentially pivotal Phase 2/3 study of RGLS8429 under an Accelerated Approval regulatory pathway to be discussed with the FDA.
  • 12 Mar 2024 According to a Regulus Therapeutics media release, In addition, company recently held a Type D meeting with FDA to discuss the accelerated approval pathway. The meeting was constructive and confirms the potential for an accelerated approval pathway based on a single Phase 2 study of RGLS8429 for the treatment of ADPKD.

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