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A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa

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Trial Profile

A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients with Epidermolysis Bullosa

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 May 2025

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At a glance

  • Drugs Allantoin (Primary)
  • Indications Epidermolysis bullosa
  • Focus Registrational; Therapeutic Use
  • Acronyms ESSENCE
  • Sponsors Amicus Therapeutics; Scioderm

Most Recent Events

  • 06 May 2025 According to Paradigm Therapeutics media release, the company announces a $12.5 Million investment by Eshelman Ventures, LLC. Funds will be used to complete all activities to support an NDA Submission in the Second Half of 2025.
  • 13 Sep 2017 Primary endpoint of proportion of patients experiencing complete closure of their target wound has not been met, according to an Amicus Therapeutics media release.
  • 13 Sep 2017 Primary endpoint of time to complete target wound closure has not been met, according to an Amicus Therapeutics media release.

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