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
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2022/12/12 | Not Applicable | Withdrawn | |||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 |
|---|---|---|---|---|---|
| Collagenase Ointment | 国药准字H20090366 | 化学药品 | 软膏 | 12/18/2019 | |
| Collagenase for Injection | 国药准字H31022658 | 化学药品 | 注射剂(注射用无菌粉末) | 3/2/2020 | |
| Collagenase for Injection | 国药准字H10960178 | 化学药品 | 注射剂(冻干) | 6/15/2020 | |
| Collagenase for Injection | 国药准字H31022659 | 化学药品 | 注射剂(注射用无菌粉末) | 3/2/2020 | |
| Collagenase for Injection | 国药准字H10960177 | 化学药品 | 注射剂(冻干) | 6/15/2020 |
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. | |||||
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