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A Phase 3, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of RGX 121 in Pediatric Participants With Neuronopathic MPS II (Hunter Syndrome)

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Trial Profile

A Phase 3, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of RGX 121 in Pediatric Participants With Neuronopathic MPS II (Hunter Syndrome)

Status: Suspended
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2026

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At a glance

  • Drugs Clemidsogene lanparvovec (Primary)
  • Indications Mucopolysaccharidosis II
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors REGENXBIO

Most Recent Events

  • 27 Feb 2026 Status changed from recruiting to suspended.
  • 28 Jan 2026 According to a REGENXBIO media release, company announced that the U.S. Food and Drug Administration (FDA) placed a clinical hold on RGX-121, for the treatment of MPS II. REGENXBIO has not yet received the full clinical hold letter and awaits additional details from the FDA.
  • 27 Nov 2025 New trial record

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