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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: 06 Jan 2026

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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

  • 22 Dec 2025 According to a Viridian Therapeutics media release, based on results form trial THRIVE and THRIVE-2, the company also plans to submit a Marketing Authorization Application to the European Medicines Agency in the first quarter of 2026.
  • 22 Dec 2025 According to a Viridian Therapeutics media release, based on results form trial THRIVE and THRIVE-2, the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for veligrotug for the treatment of thyroid eye disease (TED). The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026.
  • 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.

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