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collagenase clostridium histolyticum

Trade name: xiaflex

Biologicalapproved

Approved

Jun 4, 1965

Collagenase clostridium histolyticum is an enzyme produced by the bacterium Clostridium histolyticum that dismantles collagen. It is used as a powder-and-solvent injection kit for the treatment of Dupuytren's contracture, a condition where the fingers bend towards the palm and cannot be fully straightened, and Peyronie's disease, a connective tissue disorder involving the growth of fibrous plaques in the soft tissue of the penis. BioSpecifics Technologies developed the preparation, which is manufactured and marketed by Endo Pharmaceuticals as Xiaflex in the US and by Sobi as Xiapex in Europe. — Wikipedia

Clinical trial activity

98 trials · 61 clinical orgs · 5 marketing orgs

Phase 1
9
Phase 2
51
Phase 3
26
Phase 4
32

Earliest trial started Aug 1, 1995 (NCT00004409)

Timeline

1960s

  1. Jun 4, 1965

    Earliest FDA Approval

  2. Jun 4, 1965

    Biospecifics Technologies Corp. — Marketing Organization

  3. Jun 4, 1965

    Smith & Nephew — Marketing Organization

  4. Jun 4, 1965

    Smith & Nephew — NDA Secondary Org

1990s

  1. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  2. May 23, 1996

    Biospecifics Technologies Corp. — IND Organization

  3. May 23, 1996

    Biospecifics Technologies Corp. — IND Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Feb 2, 2010

    Auxillium — First NDA Organization

  2. Feb 2, 2010

    Auxillium — Marketing Organization

  3. Feb 2, 2010

    Auxillium — NDA Organization

2020s

  1. Jul 6, 2020

    Endo Pharmaceuticals — Marketing Organization

  2. Jul 6, 2020

    Bristol-Myers Squibb — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 4, 1965

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • aa4500
  • aa4500
  • clostridial collagenase
  • clostridium histolyticum collagenase
  • clostridium histolyticum enzymes
  • collagenase
  • collagenase
  • collagenase
  • collagenase
  • collagenase
  • collagenase
  • collagenase
  • collagenase
  • collagenase clostridium histolycum
  • collagenase clostridium histolyticum
  • collagenase clostridium histolyticum
  • collagenase clostridium histolyticum
  • collagenase clostridium histolyticum
  • collagenase clostridium histolyticum
  • collagenase clostridium histolyticum
  • collagenase clostridium histolyticum
  • en3835
  • santyl
  • santyl
  • xiaflex
  • xiaflex
  • xiaflex
  • xiaflex
  • xiapex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06649539Phase 4Oct 11, 2024Charitable Union for the Research and Education of Peyronie's Disease, Endo Pharmaceuticals
NCT06169319Phase 2Dec 31, 2023Endo Pharmaceuticals
NCT06065436N/ANov 30, 2023Mayo Clinic
NCT06151197Phase 3Nov 30, 2023Endo Pharmaceuticals
NCT05777031Phase 4Oct 2, 2023Endo Pharmaceuticals, University of Miami
NCT05646602N/AMar 31, 2023Mayo Clinic
NCT05419505Phase 2Jun 15, 2022Endo Pharmaceuticals
NCT05309525Phase 4Apr 22, 2022Luxurgery
NCT05254457Phase 3Feb 14, 2022Endo Pharmaceuticals
NCT05152173Phase 2Nov 29, 2021Endo Pharmaceuticals
NCT05108558Phase 4Sep 20, 2021Charitable Union for the Research and Education of Peyronie's Disease, CURE PD
NCT04874870Phase 3Jul 12, 2021Endo Pharmaceuticals, Florida Orthopaedic Institute, Foundation for Orthopaedic Research and Education
NCT05026216Phase 4Mar 29, 2021DMR Research, PLLC, Endo Pharmaceuticals
NCT04786106Phase 4Dec 30, 2020Charitable Union for the Research and Education of Peyronie's Disease, Endo Pharmaceuticals
NCT04677712Phase 4Dec 28, 2020DeNova Research, Endo Pharmaceuticals, Investigate MD, LLC, University of California, San Diego
NCT04580303Phase 2Oct 1, 2020Endo Pharmaceuticals
NCT04496167Phase 2Jul 29, 2020Endo Pharmaceuticals
NCT04236635Phase 2Dec 20, 2019Endo Pharmaceuticals
NCT04209530Phase 2Nov 20, 2019Endo Pharmaceuticals
NCT04170296Phase 3Nov 1, 2019Endo Pharmaceuticals
Showing 20 of 98 trials
Page 1 / 5

Organizations

Research & Development (61)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Endo PharmaceuticalsFor profit473942003
HealthpointFor profit11822008
AuxilliumFor profit6032010
Biospecifics Technologies Corp.For profit5132003
Stony Brook UniversityAcademic/Hospital5432003
Smith & NephewFor profit4312014
Charitable Union for the Research and Education of Peyronie's DiseaseAcademic/Hospital3312020
University of MiamiAcademic/Hospital3322014
Gerut, Zachary, M.D.Academic/Hospital2112012
Indiana Hand to Shoulder CenterAcademic/Hospital2212010
Mayo ClinicAcademic/Hospital2212023
State University of New YorkAcademic/Hospital2221995
University of KansasAcademic/Hospital2112012
University of TorontoAcademic/Hospital2122009
Asahi Kasei PharmaFor profit1112012
Associated Foot & Ankle SpecialistsAcademic/Hospital1012010
AzidusFor profit1112008
Cristália Produtos Químicos Farmacêuticos Ltda.For profit1112015
CURE PDAcademic/Hospital1012021
DeNova ResearchFor profit1012020
61 organizations
Page 1 / 4

Marketing (8)

OrganizationOrg typeRelationshipDate
AuxilliumFor profitMKTGFeb 2, 2010
AuxilliumFor profitNDAFeb 2, 2010
Biospecifics Technologies Corp.For profitMKTGJun 4, 1965
Biospecifics Technologies Corp.For profitINDMay 23, 1996
Bristol-Myers SquibbFor profitNDA2Jul 6, 2020
Endo PharmaceuticalsFor profitMKTGJul 6, 2020
Smith & NephewFor profitMKTGJun 4, 1965
Smith & NephewFor profitNDA2Jun 4, 1965