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Collagenase injection - BioSpecifics Technologies Corporation

Drug Profile

Collagenase injection - BioSpecifics Technologies Corporation

Alternative Names: AA-4500; AK-160; CCH; Clostridial collagenase; Collagenase clostridium histolyticum; Cordase; EN-3835; PF-5076985; Plaquase; XIAFLEX; Xiapex

Latest Information Update: 26 Nov 2019

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At a glance

  • Originator BioSpecifics Technologies Corporation
  • Developer Actelion Pharmaceuticals; Asahi Kasei; BioSpecifics Technologies Corporation; Endo International; Swedish Orphan Biovitrum
  • Class Collagenases; Urologics
  • Mechanism of Action Collagenase replacements
  • Orphan Drug Status

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

    Yes - Peyronie's disease; Dupuytren's contracture
  • New Molecular Entity No

Highest Development Phases

  • Marketed Dupuytren's contracture; Peyronie's disease
  • Preregistration Cellulite
  • Phase II Frozen shoulder; Lipoma
  • Phase I Uterine leiomyoma
  • Preclinical Breast disorders
  • Research Metabolic disorders; Musculoskeletal disorders
  • Discontinued Hypertrophic scars; Keloids; Tendon injuries

Most Recent Events

  • 26 Nov 2019 Phase-III clinical trials in Cellulite in USA (Parenteral) (NCT04170296)
  • 19 Nov 2019 FDA assigns PDUFA action date of 06/07/2020 for Collagenase injection for cellulite
  • 19 Nov 2019 The USA FDA accepts BLA for Cellulite for review
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