Overview
Collagenase clostridium histolyticum is an enzyme produced by the bacterium Clostridium histolyticum. It is beneficial in the breakdown of collagen plaques for the treatment of Dupuytren's contracture and Peyronie's disease. The topical formulation is used for the debridement of necrotic tissue due to burns or chronic ulcers. On July 6, 2020 a combination of injectable bacterial collagenases was approved by the FDA for the treatment of cellulite in adult women. Also known as Qwo, this injection is the first approved injectable treatment for cellulite and was developed by Endo International.
Indication
Collagenase clostridium histolyticum is indicated for the treatment of adults with Dupuytren's contracture with a palpable cord. Additionally, it is used to treat men with Peyronie's disease diagnosed with a penile curvature deformity of at least a 30-degree angle at the beginning of therapy in addition to palpable plaques. Collagenase ointment is used for the tissue debridement of chronic dermal ulcers and severely burned tissues. The combination collagenase product, also known as Qwo, is used for the treatment of moderate to severe cellulite in the buttocks of adult women.
Associated Conditions
- Dupuytren's Contracture of the Hand (Viking's Disease)
- Peyronie's Disease
- Necrotic tissue
Research Report
Collagenase clostridium histolyticum (DB00048): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Therapeutic Applications
1.0 Executive Summary
Collagenase clostridium histolyticum (CCH) represents a landmark therapeutic innovation, establishing a new class of injectable enzymatic agents for the treatment of localized fibroproliferative disorders. Derived from the bacterium Clostridium histolyticum, CCH is a highly purified biologic drug designed to enzymatically lyse pathological collagen deposits that are the hallmark of specific debilitating conditions.[1] Its primary mechanism of action involves the targeted disruption of the collagen triple helix, a process that effectively performs a non-surgical, biochemical fasciotomy at the site of injection.[3]
Under the brand name Xiaflex, CCH has secured U.S. Food and Drug Administration (FDA) approval for two distinct indications: the treatment of Dupuytren's contracture in adults with a palpable cord and the treatment of Peyronie's disease in adult men with a palpable plaque and significant penile curvature.[5] A third formulation, formerly marketed as Qwo, was approved for the aesthetic treatment of cellulite in adult women but has since been discontinued.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/18 | Phase 4 | Recruiting | Charitable Union for the Research and Education of Peyronie's Disease | ||
2023/12/13 | Phase 2 | Completed | Endo Pharmaceuticals | ||
2023/11/30 | Phase 3 | Recruiting | Endo Pharmaceuticals | ||
2023/10/04 | Not Applicable | Recruiting | |||
2023/03/20 | Phase 4 | Recruiting | |||
2022/12/12 | Not Applicable | Withdrawn | |||
2022/04/04 | Phase 4 | Completed | Luxurgery | ||
2022/02/24 | Phase 3 | Completed | Endo Pharmaceuticals | ||
2021/08/30 | Phase 4 | Completed | DMR Research, PLLC | ||
2021/05/06 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| SMITH & NEPHEW, INC | 50484-010 | TOPICAL | 250 [arb'U] in 1 g | 3/24/2017 | |
| Endo Aesthetics LLC | 73611-300 | INTRALESIONAL | 0.23 mg in 1 mL | 3/13/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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