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A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

Trial Profile

A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2026

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At a glance

  • Drugs Brelovitug (Primary)
  • Indications Hepatitis D
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms AZURE-4
  • Sponsors Bluejay Therapeutics; Mirum Pharmaceuticals

Most Recent Events

  • 27 Jan 2026 According to Mirum Pharmaceuticals media release, the United States. Brelovitug has received Breakthrough Therapy designation from the FDA and PRIME designation from the European Medicines Agency and is currently being evaluated in the global AZURE Phase 3 registrational program, with topline data expected in the second half of 2026.
  • 26 Jan 2026 According to Mirum Pharmaceuticals media release, Bluejay Therapeutics has been acquired and merged into Mirum Pharmaceuticals.
  • 29 Dec 2025 New trial record

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