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Allantoin - Amicus Therapeutics

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Drug Profile

Allantoin - Amicus Therapeutics

Alternative Names: SD-101 - Amicus Therapeutics; Zorblisa

Latest Information Update: 24 Aug 2023

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At a glance

  • Originator Paradigm Therapeutics Inc; Scioderm
  • Developer Amicus Therapeutics
  • Class Anti-inflammatories; Antiacnes; Antipsoriatics; Hydantoins; Imidazolidines; Keratolytics; Small molecules; Urea compounds
  • Mechanism of Action Antioxidants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Epidermolysis bullosa
  • New Molecular Entity No

Highest Development Phases

  • Discontinued Diabetic foot ulcer; Epidermolysis bullosa; Psoriasis

Most Recent Events

  • 22 Aug 2023 Paradigm Therapeutics acquires allantoin from Amicus Therapeutics
  • 22 Aug 2023 Paradigm Therapeutics intends to discuss the current data with the FDA to expedite a path forward towards registration of this therapy for patients with all epidermolysis bullosa subtypes
  • 03 Sep 2018 Amicus Therapeutics terminates an extension trial in Epidermolysis bullosa in USA, Australia, Austria, France, Germany, Israel, Lithuania, Netherlands, Poland, Serbia, Spain, and the United Kingdom, due to GMP deficiencies identified during an FDA inspection at the site of the manufacturer (NCT02090283)
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