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A phase 1/2 multiple ascending dose (MAD) trial of ENTR-601-45 in patients with Duchenne muscular dystrophy (DMD) who are exon 45 skipping amenable

Trial Profile

A phase 1/2 multiple ascending dose (MAD) trial of ENTR-601-45 in patients with Duchenne muscular dystrophy (DMD) who are exon 45 skipping amenable

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs ENTR 601 45 (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Therapeutic Use
  • Acronyms ELEVATE-45-201

Most Recent Events

  • 24 Mar 2025 According to an Entrada Therapeutics media release, the company has received authorization in the United Kingdom to initiate this phase 1/2 study, which is on track to be initiated in Q3 2025. The company plans to initiate and run the studies in the U.K. and EU and then share these study results with the FDA to potentially enable registrational studies in the U.S. Regulatory filings have been submitted to EU and review is ongoing.
  • 13 May 2024 New trial record
  • 07 May 2024 According to an Entrada Therapeutics media release, company is on track to submit regulatory applications in the fourth quarter of 2024 to initiate independent global Phase 2 clinical development study for ENTR-601-45 in patients with DMD who are exon 45 skipping amenable.

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