Collagenase Clostridium Histolyticum
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 68 · started per year
Also used as a comparator or background therapy in 30 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 24 trials | ||||||
| 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 |
| Phase 2 | NCT02249052 Comparator | Aug 2014 → Apr 2016 | lipoma | Gerut, Zachary, M.D. | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT04874870 Comparator | Jul 2021 → Dec 2023 | palmar fibromatosis | Foundation for Orthopaedic Research and Education | Completed | No outcome recorded |
| Phase 3 | NCT03446781 Comparator | Feb → Sep 2018 | panniculitis and localized lipodystrophy | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT03428750 Comparator | Feb → Sep 2018 | panniculitis and localized lipodystrophy | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT02725528 Comparator | Jul 2017 → Dec 2021 | palmar fibromatosis | McMaster University | Completed | No outcome recorded |
| Phase 3 | NCT02004626 Comparator | Jan → Jun 2015 | decubitus ulcer | Cristália Produtos Químicos Farmacêuticos Ltda. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02267460 Comparator | Oct 2014 → Oct 2015 | Peyronie disease | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT05309525 Comparator | Apr → Sep 2022 | — | Luxurgery | Completed | No outcome recorded |
| Phase 4 | NCT04786106 Comparator | Dec 2020 → Feb 2027 expected | Peyronie disease | Charitable Union for the Research and Education of Peyronie's Disease | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04677712 Comparator | Dec 2020 → Jun 2021 | cellulitis, panniculitis and localized lipodystrophy | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 4 | NCT03000114 Comparator | Jan 2016 → Jan 2021 | palmar fibromatosis | University of Calgary | Unknown | No outcome recorded |
| Phase 4 | NCT02476461 Comparator | Apr 2015 → Apr 2016 | palmar fibromatosis | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02647619 Comparator | Oct 2013 → Apr 2022 | palmar fibromatosis | University Hospital, Akershus | Completed | No outcome recorded |
| Phase 4 | NCT02673229 Comparator | Sep 2013 → Dec 2018 | — | University of Kansas Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT01516463 Comparator | Mar 2012 → Jun 2013 | — | Healthpoint | Withdrawn | No outcome recorded |
| Phase 4 | NCT01408277 Comparator | Aug 2011 → Nov 2012 | ulcer of lower limbs | Healthpoint | Completed | No outcome recorded |
| Phase 4 | NCT01226121 Comparator | Dec 2010 → Dec 2012 | palmar fibromatosis | Indiana Hand to Shoulder Center | Terminated | No outcome recorded |
| Phase 4 | NCT01143727 Comparator | Jul 2010 → Oct 2011 | ulcer of lower limbs | Healthpoint | Completed | No outcome recorded |
| Phase 4 | NCT01143714 Comparator | Jun 2010 → Apr 2012 | ulcer of lower limbs | Healthpoint | Completed | No outcome recorded |
| Phase 4 | NCT01056198 Comparator | Feb 2010 → Aug 2011 | ulcer of lower limbs | Healthpoint | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06065436 Background | Jan 2024 → Dec 2026 expected | Peyronie disease, erectile dysfunction | Mayo Clinic | Recruiting | No outcome recorded |
| — | NCT05646602 Background | Mar 2023 → Dec 2024 | Peyronie disease, erectile dysfunction | Mayo Clinic | Withdrawn | No outcome recorded |
| — | NCT03722485 Comparator | Dec 2018 → Apr 2022 | — | KCI USA, Inc | Terminated | No outcome recorded |
| — | NCT02482948 Comparator | Jun 2015 → Mar 2017 | ulcer disease | Integra LifeSciences Corporation | Terminated | No outcome recorded |
| — | NCT01538017 Comparator | Feb 2012 → Oct 2016 | palmar fibromatosis | Jeppe Lange, MD | Completed | No outcome recorded |
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 102 sources stand behind the page.
| Field | Value | Cited 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 ↗37“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 ↗ “Collagenase Clostridium Histolyticum (CCH)” NCT04170296 ↗ |
| Known as | AA4500 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01430169 ↗ |
| Known as | AK160 | “AK160 (Collagenase Clostridium Histolyticum) 0.58 mg” NCT01588353 ↗ |
| Known as | CCH | “We tested the hypothesis that injection of a purified form of collagenase Clostridium histolyticum (CCH) that selectively digests type I and type III collagens would alter ECM...” PMID 34323413 ↗ Jul 20219“Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment...” PMID 25388099 ↗ Nov 2014 “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 “CCH (collagenase clostridium histolyticum)” NCT03675685 ↗ “Collagenase Clostridium Histolyticum (CCH)” NCT05777031 ↗ “Collagenase Clostridium Histolyticum (CCH)” NCT04170296 ↗ “Collagenase Clostridium Histolyticum (CCH)” NCT06169319 ↗ |
| Known as | CCH-aaes | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03526549 ↗ |
| 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 ↗ |
| Known as | Clostridial collagenase for injection (AA4500) | “Clostridial collagenase for injection (AA4500)” NCT00755222 ↗ |
| Known as | Clostridium Histolyticum Collagenase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02948842 ↗ |
| 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 ↗ |
| 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 ↗3“OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite.” PMID 33840781 ↗ May 2021 “OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite.” PMID 33840781 ↗ May 2021 |
| 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 ↗ |
| 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.” NCT07693569 ↗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.” NCT07693556 ↗ “Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]” NCT03192020 ↗ “Xiaflex (FDA approved collagenase)” NCT01237964 ↗ |
| Known as | Xiaflex( Collagenase Clostridium Histolytiucm) | “Xiaflex( Collagenase Clostridium Histolytiucm)” NCT01237964 ↗ |
| Known as | XIAFLEX, Collagenase Clostridium Histolyticum | “XIAFLEX, Collagenase Clostridium Histolyticum” NCT02249052 ↗ |
| Known as | Xiapex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01229436 ↗ |
| 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 ↗ |