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A Phase I study of JAG201 in pediatric patients (2+ years) with JAG201 with expansion into adults (18+ years) with autism spectrum disorder (ASD) and Phelan-McDermid syndrome

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Trial Profile

A Phase I study of JAG201 in pediatric patients (2+ years) with JAG201 with expansion into adults (18+ years) with autism spectrum disorder (ASD) and Phelan-McDermid syndrome

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2024

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At a glance

  • Drugs JAG 201 (Primary)
  • Indications Pervasive child development disorders; Telomeric 22q13 Monosomy Syndrome
  • Focus Adverse reactions

Most Recent Events

  • 09 Jul 2024 According to Jaguar Gene Therapy media release, company announced the receipt of U.S. Food and Drug Administration (FDA) responses from a Type C meeting regarding the Phase I clinical trial for JAG201. Company plans to dose the first pediatric patient in Q1 of 2025 with expansion into adults following the pediatric cohort. Company has reached agreement with the FDA to dose both pediatric and adult patients in the initial Phase I clinical trial of JAG201.
  • 06 Feb 2024 New trial record
  • 31 Jan 2024 According to Jaguar Gene Therapy media release, company announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for JAG201.The company plans to initiate a Phase I trial in adults with autism spectrum disorder(ASD)or phelan-mcdermid syndrome(PSM) in the United States in the second half of the year.

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