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A Multiple Ascending Dose (MAD) Safety, Tolerability and Efficacy Study of Veligrotug (VRDN-001), a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Normal Healthy Volunteers (NHV(s) and Subjects With Thyroid Eye Disease (TED)

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Trial Profile

A Multiple Ascending Dose (MAD) Safety, Tolerability and Efficacy Study of Veligrotug (VRDN-001), a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Normal Healthy Volunteers (NHV(s) and Subjects With Thyroid Eye Disease (TED)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2025

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At a glance

  • Drugs Veligrotug (Primary)
  • Indications Graves ophthalmopathy
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms THRIVE
  • Sponsors Viridian Therapeutics

Most Recent Events

  • 03 Nov 2025 According to a Viridian Therapeutics media release, FDA decision for acceptance if BLA for veligrotug is expected within 60 days of submission.
  • 03 Nov 2025 According to a Viridian Therapeutics media release, the company announced submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for veligrotug for the treatment of thyroid eye disease (TED). This BLA includes a request for Priority Review, which if granted, could accelerate review timing for a potential mid-2026 veligrotug commercial launch, if approved.
  • 15 Sep 2025 According to a Viridian Therapeutics media release, Company anticipates Biologics License Application (BLA) submission in November 2025 and commercial launch in mid-2026 , if approved under Priority Review.

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