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EXPEDITION: A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome

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Trial Profile

EXPEDITION: A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 Oct 2025

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At a glance

  • Drugs ETX 101 (Primary)
  • Indications Dravet syndrome
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms EXPEDITION
  • Sponsors Encoded Therapeutics

Most Recent Events

  • 02 Sep 2025 According to Encoded Therapeutics media release, enrollment in the dose-escalation studies interim clinical efficacy data presentation planned for 4Q25
  • 02 Sep 2025 According to Encoded Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ETX101 following review of preliminary seizure data from patients treated in its ongoing Phase 1/2 program.
  • 18 Jul 2025 Planned End Date changed from 1 Dec 2029 to 1 Sep 2030.

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