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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: 03 Dec 2018

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

Highest Development Phases

  • Marketed Dupuytren's contracture; Peyronie's disease
  • Phase III 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

  • 15 Nov 2018 BioSpecifics Technologies expects to submit BLA to US FDA in second half of 2019
  • 14 Nov 2018 9253629 - added results for RELEASE 1 and 2 trial in TT, AE
  • 07 Nov 2018 Positive efficacy and adverse events results from the phase III RELEASE-1 and RELEASE-2 trials in Cellulite were released by Endo Pharmaceuticals
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