Drugs / Collagenase Clostridium Histolyticum
last change Sep 2026 re-read 9 days ago

Collagenase Clostridium Histolyticum

Protein / enzyme biologic

Developed for
palmar fibromatosis · Peyronie disease · cellulitis · panniculitis and localized lipodystrophy · decubitus ulcer · frozen shoulder · ulcer of lower limbs · arterial occlusion
+5 more · chronic ulcer of skin · extensor tendons of finger anomalies · lipoma · plantar fasciitis · ulcer disease
Investigated by
Endo USA Inc., a Keenova Therapeutics Company · Healthpoint · Stony Brook University · Smith & Nephew, Inc. · Charitable Union for the Research and Education of Peyronie's Disease · State University of New York
+30 more · The University of Texas Health Science Center, Houston · Advance Biofactures Corporation · Asahi Kasei Therapeutics Corporation · Auxilium Pharmaceuticals, Inc. · Azidus Brasil · Biospecifics Technologies Corp. · Central Finland Hospital District · DMR Research, PLLC · Finnish Institute for Health and Welfare · Helsinki University Central Hospital · Hospital for Special Surgery, New York · Indiana Hand to Shoulder Center · Kuopio University Hospital · Louisiana State University Health Sciences Center Shreveport · Manhattan Medical Research Practice, PLLC · Matrizyme Pharma Corporation · Medcare Oy · Men's Health Boston · Orton Orthopaedic Hospital · Oulu University Hospital · Region Skane · Sheba Medical Center · Sunnybrook Health Sciences Centre · Tampere University · Tampere University Hospital · Turku University Hospital · University of Alberta · University of Louisville · University of Miami · Zachary Gerut

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed familial Dupuytren contracture 1 milestone
Filed Other XIAFLEX familial Dupuytren contracture 2013-07-16

“A XIAFLEX submission has been filed for approval in Australia for the treatment of Dupuytren's contracture.” sobi.com ↗

Filed Peyronie disease 1 milestone
Filed EU (EMA) Xiapex Peyronie disease 2014-06-25

“Sobi has filed for an extension of the label for Xiapex® (collagenase clostridium histolyticum) with the European Medicines Agency (EMA)” sobi.com ↗

Approved Indication not stated 3 milestones
Label expansions (3) US (FDA) XIAFLEX — 2013-12-06 – 2015-05-15 fda.gov ↗
Approved EU (EMA) Xiapex — 2011-02-28 europa.eu ↗
Approved US (FDA) SANTYL — 1965-06-04 fda.gov ↗

Trials 57

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT07693569 Sep 2026 → May 2031 expected — The University of Texas Health Science Center, Houston Not yet recruiting No outcome recorded
Phase 0 NCT07693556 Sep 2026 → May 2031 expected — The University of Texas Health Science Center, Houston Not yet recruiting No outcome recorded
Phase 14 trials
Phase 1 NCT03675685 Sep → Nov 2018 panniculitis and localized lipodystrophy Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 1 NCT01518907 Jan → Dec 2012 cellulitis, panniculitis and localized lipodystrophy Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 1 NCT01271335 Nov 2009 → Sep 2011 arterial occlusion Sunnybrook Health Sciences Centre Completed No outcome recorded
Phase 1 NCT00528931 Sep → Dec 2007 palmar fibromatosis Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00261209 Jan 2005 → Jan 2008 extensor tendons of finger anomalies Stony Brook University Completed No outcome recorded
Phase 217 trials
Phase 2 NCT06169319 Jan → Sep 2024 plantar fasciitis Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT04236635 Dec 2019 → Sep 2020 — Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT03329989 Nov 2017 → Sep 2018 cellulitis, panniculitis and localized lipodystrophy Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT02942160 Oct 2016 → Jun 2018 cellulitis, panniculitis and localized lipodystrophy Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT02724644 Feb → Sep 2016 cellulitis, panniculitis and localized lipodystrophy Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT02193828 Jul → Dec 2014 palmar fibromatosis Endo USA Inc., a Keenova Therapeutics Company Completed Mixed
Phase 2 NCT01753180 Apr 2014 → Dec 2015 arterial occlusion Matrizyme Pharma Corporation Completed No outcome recorded
Phase 2 NCT02006719 Nov 2013 → Dec 2014 frozen shoulder Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT01987986 Oct 2013 → Aug 2014 panniculitis and localized lipodystrophy Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT00261144 Feb 2013 → Feb 2014 cellulitis Stony Brook University Unknown No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00701974 Feb 2008 ulcer disease Azidus Brasil Suspended No outcome recorded Stop: Business
Phase 314 trials · 5 met primary
Phase 3 NCT01776892 May 2013 → Mar 2014 palmar fibromatosis University of Alberta Withdrawn No outcome recorded
Phase 3 NCT01685437 Sep 2012 → Dec 2013 Peyronie disease Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 3 NCT01674634 Sep 2012 → Jul 2013 palmar fibromatosis Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 3 NCT01588353 May 2012 → Jan 2014 palmar fibromatosis Asahi Kasei Therapeutics Corporation Completed No outcome recorded
Phase 3 NCT01407068 Sep 2011 → Feb 2012 palmar fibromatosis Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 3 NCT01243411 Nov 2010 → Aug 2012 Peyronie disease Endo USA Inc., a Keenova Therapeutics Company Completed Met primary
Phase 3 NCT01221623 Oct 2010 → Mar 2012 Peyronie disease Endo USA Inc., a Keenova Therapeutics Company Completed Met primary
Phase 3 NCT01221597 Sep 2010 → Apr 2012 Peyronie disease Endo USA Inc., a Keenova Therapeutics Company Completed Met primary
Phase 3 NCT00528424 Dec 2007 → Nov 2008 palmar fibromatosis Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 3 NCT00528840 Oct 2007 → Oct 2008 palmar fibromatosis Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 417 trials · 1 met primary · 1 missed
Phase 4 NCT06649539 Oct 2024 → Oct 2029 expected Peyronie disease Charitable Union for the Research and Education of Peyronie's Disease Recruiting No outcome recorded
Phase 4 NCT05777031 Oct 2023 → Jan 2027 expected Peyronie disease, psychosexual disorder University of Miami Active not recruiting No outcome recorded
Phase 4 NCT05108558 Sep 2021 → Dec 2025 overdue Peyronie disease Charitable Union for the Research and Education of Peyronie's Disease Active not recruiting No outcome recorded
Phase 4 NCT05026216 Mar → Aug 2021 cellulitis DMR Research, PLLC Completed No outcome recorded
Phase 4 NCT03815331 Jan 2019 → Dec 2020 Peyronie disease Men's Health Boston Completed No outcome recorded
Phase 4 NCT03767452 Oct 2018 → Dec 2019 Peyronie disease Manhattan Medical Research Practice, PLLC Unknown No outcome recorded
Phase 4 NCT03406338 Mar 2018 → Sep 2024 overdue palmar fibromatosis Region Skane Active not recruiting No outcome recorded
Phase 4 NCT03192020 Sep 2017 → May 2026 overdue palmar fibromatosis Tampere University Active not recruiting Met primary
Phase 4 NCT02716519 Aug 2016 → Dec 2018 decubitus ulcer, ulcer of lower limbs Smith & Nephew, Inc. Withdrawn No outcome recorded Stop: Business
Phase 4 NCT02718625 Aug 2016 → Mar 2017 decubitus ulcer Smith & Nephew, Inc. Terminated No outcome recorded Stop: Business
Phase not applicable1 trial
— NCT01208220 Jun 2010 → Dec 2011 decubitus ulcer Louisiana State University Health Sciences Center Shreveport Terminated No outcome recorded Stop: Enrollment
Comparator or background therapy25 trials
Phase 1 NCT04963829 Comparator Feb → Nov 2018 chronic ulcer of skin, ulcer disease Universidade do Vale do Sapucai Completed No outcome recorded
Phase 1 NCT02131961 Background Oct 2014 → Jun 2015 ulcer of lower limbs University of Miami Completed No outcome recorded
Phase 2 NCT04580303 Comparator Oct 2020 → Aug 2021 cellulitis, cutis laxa, panniculitis and localized lipodystrophy Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded
Phase 2 NCT03588130 Comparator Dec 2019 → Dec 2021 ulcer of lower limbs MediWound Ltd Completed No outcome recorded
Phase 2 NCT03632993 Comparator Sep 2018 → Jan 2019 — Endo USA Inc., a Keenova Therapeutics Company Completed No outcome recorded

News releases announcing trial results or a regulatory action · 17

DateIssuerRelease
2026-08-03 Mallinckrodt Results Keenova Announces Publication of XIAFLEX® (collagenase clostridium histolyticum) Manuscript in Translational Andrology and Urology gcs-web.com ↗
2026-08-03 Endo USA Inc., a Keenova Therapeutics Company Results Keenova Announces Publication of XIAFLEX® (collagenase clostridium histolyticum) Manuscript in Translational Andrology and Urology mediaroom.com ↗
This reinforces that pain and disease duration, while important factors, should not be the sole determinants of treatment timing, but treatment decisions should be grounded in a comprehensive clinical assessment and the evolving understanding of Peyronie's disease.
2026-07-08 Mallinckrodt Results Keenova Announces Positive Phase 3 Results in Clinical Trial of XIAFLEX® (collagenase clostridium histolyticum) for Treating Plantar Fibromatosis gcs-web.com ↗
The pivotal trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in pain versus placebo, as measured by the Average Daily Pain Intensity on the Numeric Rating Scale (NRS).
2026-07-08 Endo USA Inc., a Keenova Therapeutics Company Results Keenova Announces Positive Phase 3 Results in Clinical Trial of XIAFLEX® (collagenase clostridium histolyticum) for Treating Plantar Fibromatosis mediaroom.com ↗
Keenova Therapeutics plc announced today positive results from its Phase 3 clinical trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of plantar fibromatosis, a chronic medical condition that causes nodules composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot.
2026-05-15 Mallinckrodt Results Keenova Announces Newly Updated Peyronie's Disease Study Results at American Urology Association Meeting gcs-web.com ↗
The data to be presented will highlight that the clinical effectiveness and safety of XIAFLEX (collagenase clostridium histolyticum) in patients with ventral curvature are consistent with outcomes observed in patients with other clinical presentations of Peyronie's disease.
2026-05-15 Endo USA Inc., a Keenova Therapeutics Company Results Keenova Announces Newly Updated Peyronie's Disease Study Results at American Urology Association Meeting mediaroom.com ↗
2026-03-31 Endo USA Inc., a Keenova Therapeutics Company Results Keenova Announces Unaudited Fourth Quarter 2025 Financial Results mediaroom.com ↗
Hammer Toe Trial Meets Primary Safety Endpoint and Secondary, Exploratory Efficacy Endpoints
2026-03-03 Mallinckrodt Results Keenova Publishes XIAFLEX® (collagenase clostridium histolyticum) Analysis in Journal of Hand Surgery Global Online gcs-web.com ↗
Findings suggest XIAFLEX may offer an alternative to repeat surgery and add to existing insights on recurrence management.
2026-03-03 Endo USA Inc., a Keenova Therapeutics Company Results Keenova Publishes XIAFLEX® (collagenase clostridium histolyticum) Analysis in Journal of Hand Surgery Global Online mediaroom.com ↗
Findings suggest XIAFLEX may offer an alternative to repeat surgery and add to existing insights on recurrence management.
2026-02-24 Mallinckrodt Results Keenova Unveils Clinical Data from Phase 2 Plantar Fibromatosis Study at the ACFAS Annual Meeting gcs-web.com ↗
Patients receiving initial treatment or re‑treatment with CCH demonstrated a safety profile consistent with the earlier phase 2 study.
2026-02-24 Endo USA Inc., a Keenova Therapeutics Company Results Keenova Unveils Clinical Data from Phase 2 Plantar Fibromatosis Study at the ACFAS Annual Meeting mediaroom.com ↗
Patients receiving initial treatment or re‐treatment with CCH demonstrated a safety profile consistent with the earlier phase 2 study.
2025-05-13 MediWound Ltd Results MediWound Announces Publication of Phase II EscharEx® Data Demonstrating Superiority Over Collagenase in Venous Leg Ulcers mediwound.com ↗
Compared to SANTYL, EscharEx achieved faster and more effective debridement and promoted healthier granulation tissue, both key to optimal wound bed preparation.

All press releases naming this drug 20 releases

DateIssuerRelease

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 85 sources stand behind the page.

FieldValueCited text
Known as collagenase clostridium histolyticum “The primary objective of this pilot study is to determine whether testosterone therapy offers increased efficacy of Xiaflex® (collagenase clostridium histolyticum) in subjects...” NCT03815331 ↗
36

“Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment...” PMID 25388099 ↗ Nov 2014

“Combined data from the collagenase Clostridium histolyticum phase 3 study program, IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and...” PMID 26199168 ↗ Jul 2015

“Injection of collagenase clostridium histolyticum, an office-based, nonsurgical option, may reduce joint contractures caused by Dupuytren's disease.” PMID 19726771 ↗ Sep 2009

“Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders” NCT05108558 ↗

“Collagenase clostridium histolyticum will be used to treat participants in this arm of the study.” NCT01776892 ↗

“enzyme, collagenase clostridium histolyticum, xiaflex” NCT02725528 ↗

“EN3835 0.84mg (Collagenase Clostridium Histolyticum)” NCT03428750 ↗

“AA4500 collagenase clostridium histolyticum” NCT01407068 ↗

NCT04786106 ↗

NCT05777031 ↗

Show 26 more sources

Known as AA4500 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00755222 ↗
8

NCT01430169 ↗

NCT00528424 ↗

NCT02249052 ↗

NCT01221623 ↗

NCT02267460 ↗

NCT01407068 ↗

NCT01483963 ↗

NCT01685437 ↗

Known as AK160 “AK160 (Collagenase Clostridium Histolyticum) 0.58 mg” NCT01588353 ↗
Known as CCH “Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment...” PMID 25388099 ↗ Nov 2014
7

“Endo Pharmaceuticals Inc. (Endo) is developing collagenase clostridium histolyticum (CCH) for the treatment of EFP.” NCT03632993 ↗

“OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite.” PMID 33840781 ↗ May 2021

“Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)” NCT04786106 ↗

“collagenase clostridium histolyticum (CCH) injection” PMID 28854973 ↗ Aug 2017

“Collagenase Clostridium Histolyticum (CCH)” NCT05777031 ↗

“Collagenase Clostridium Histolyticum (CCH)” NCT06169319 ↗

“CCH (collagenase clostridium histolyticum)” NCT03675685 ↗

Known as CCO “Enzymatic debridement with clostridial collagenase ointment (CCO) can be used to remove necrotic tissue from wounds.” PMID 25767565 ↗ Feb 2015
Known as Clostridial Collagenase “Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver” NCT02581488 ↗
4

“Enzymatic debridement with clostridial collagenase ointment (CCO) can be used to remove necrotic tissue from wounds.” PMID 25767565 ↗ Feb 2015

“Clostridial Collagenase (Santyl®) Ointment” NCT02111291 ↗

NCT01226121 ↗

NCT01265420 ↗

Known as Clostridial collagenase for injection (AA4500) “Clostridial collagenase for injection (AA4500)” NCT00755222 ↗
Known as Collagenase “A Vehicle-Controlled Study to Determine the Effect of Four Weeks of Debridement With Collagenase Santyl Ointment (Santyl) on the Healing of Diabetic Foot Ulcers” NCT01143714 ↗
21

“Unfortunately, to date there has been no research examining the potential benefits of using collagenase in patients with facial burn injuries.” NCT01668030 ↗

“Collagenase” NCT00261144 ↗

NCT01753180 ↗

NCT02482948 ↗

NCT07693556 ↗

NCT04963829 ↗

NCT07693569 ↗

NCT01208220 ↗

NCT02131961 ↗

NCT01197898 ↗

Show 11 more sources

Known as Collagenase clostridium histolyticum-aaes “Collagenase clostridium histolyticum-aaes is a combination of bacterial collagenases AUX-I and AUX-II, in an approximate 1:1 mass ratio, which are isolated and purified from...” NCT05026216 ↗
2

“OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite.” PMID 33840781 ↗ May 2021

NCT05309525 ↗

Known as EN3835 “EN3835 0.84mg (Collagenase Clostridium Histolyticum)” NCT03329989 ↗
Known as IRUXOL “collagenase (IRUXOL)” NCT00701974 ↗
Known as Kollagenase “collagenase (Kollagenase)” NCT00701974 ↗
Known as Qwo “To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Clostridium Histolyticum-aases, Qwo, for the Treatment of Mild to Moderate Cellulite in Adult Females...” NCT05026216 ↗
Known as Santyl “A Vehicle-Controlled Study to Determine the Effect of Four Weeks of Debridement With Collagenase Santyl Ointment (Santyl) on the Healing of Diabetic Foot Ulcers” NCT01143714 ↗
10

“This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility.” NCT02718625 ↗

“Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver” NCT02581488 ↗

“Evaluate the effectiveness of Collagenase Santyl ointment when used in conjunction with NPWT for the treatment of chronic pressure ulcers” NCT01208220 ↗

“Santyl (Enzymatic debridement) or commercially approved Hydrogel” NCT03588130 ↗

“Biological: Collagenase Santyl Ointment” NCT01197898 ↗

“Collagenase SANTYL® Ointment” NCT02111291 ↗

NCT02718625 ↗

NCT01143727 ↗

NCT01056198 ↗

NCT02716519 ↗

Known as Xiaflex “XIAFLEX is an FDA-Approved collagenase for treatment of Dupuytren's contracture with a palpable cord in the fingers, and Peyronie's disease in the penile tissue.” NCT07693556 ↗
8

“XIAFLEX is an FDA-Approved collagenase for treatment of Dupuytren's contracture with a palpable cord in the fingers, and Peyronie's disease in the penile tissue.” NCT07693569 ↗

“Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]” NCT03192020 ↗

“Xiaflex (FDA approved collagenase)” NCT01237964 ↗

NCT01450397 ↗

NCT03767452 ↗

NCT03815331 ↗

NCT03000114 ↗

NCT01674634 ↗

Known as Xiaflex( Collagenase Clostridium Histolytiucm) “Xiaflex( Collagenase Clostridium Histolytiucm)” NCT01237964 ↗
Known as XIAFLEX, Collagenase Clostridium Histolyticum “XIAFLEX, Collagenase Clostridium Histolyticum” NCT02249052 ↗
Modality Protein / enzyme biologic “Biological: collagenase clostridium histolyticum” NCT00528840 ↗
Route Other “Patients receive a single collagenase injection into the target finger cord on day 0.” NCT00014742 ↗