Collagenase clostridium histolyticum
Qwo, Xiaflex, Xiapex (collagenase clostridium histolyticum) is an enzyme pharmaceutical. Collagenase clostridium histolyticum was first approved as Xiaflex on 2010-02-02. It is used to treat burns, dupuytren contracture, penile induration, and skin ulcer in the USA. It has been approved in Europe to treat dupuytren contracture.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Santyl
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Collagenase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Santyl | collagenase | Smith+Nephew | N-101995 RX | 1965-06-04 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| collagenase santyl | Biologic Licensing Application | 2019-05-17 |
| qwo | Biologic Licensing Application | 2022-07-22 |
| xiaflex | Biologic Licensing Application | 2024-04-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| burns | — | D002056 | T30.0 |
| skin ulcer | HP_0200042 | D012883 | L98.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
collagenase clostridium histolyticum, Xiaflex, Auxilium Pharmaceuticals, Inc. | |||
| 2120-12-06 | Orphan excl. | ||
Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
136 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dupuytren contracture | D004387 | EFO_0004229 | M72.0 | 1 | 2 | 13 | 9 | 12 | 37 |
| Contracture | D003286 | HP_0001371 | M62.4 | 1 | 2 | 8 | 8 | 9 | 28 |
| Penile induration | D010411 | — | N48.6 | — | 2 | 5 | 6 | 5 | 18 |
| Ulcer | D014456 | MPATH_579 | — | 2 | 2 | 2 | 8 | 3 | 16 |
| Cellulite | D000071697 | — | — | 1 | 7 | 3 | 2 | 1 | 14 |
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | — | — | 8 | 1 | 10 |
| Foot ulcer | D016523 | — | — | 1 | — | — | 8 | — | 9 |
| Burns | D002056 | — | T30.0 | — | 1 | — | 2 | 2 | 5 |
| Pressure ulcer | D003668 | — | — | — | — | 1 | 2 | 1 | 4 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | 1 | 3 | 4 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Edema | D004487 | HP_0000969 | R60.9 | 2 | 5 | 3 | — | 1 | 11 |
| Macular edema | D008269 | — | — | — | — | 1 | — | — | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | 1 | — | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | 1 | — | — | 1 |
| Skin ulcer | D012883 | HP_0200042 | L98.4 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bursitis | D002062 | EFO_1000941 | M71.9 | — | 4 | — | — | — | 4 |
| Keloid | D007627 | EFO_0004212 | L91.0 | — | 2 | — | — | — | 2 |
| Cutis laxa | D003483 | — | Q82.8 | — | 1 | — | — | 1 | 2 |
| Varicose ulcer | D014647 | — | — | — | 1 | — | — | 1 | 2 |
| Lipoma | D008067 | — | D17.9 | — | 2 | — | — | — | 2 |
| Abdominal aortic aneurysm | D017544 | EFO_0004214 | — | — | 1 | — | — | — | 1 |
| Aneurysm | D000783 | HP_0002617 | I72.9 | — | 1 | — | — | — | 1 |
| Aortic aneurysm | D001014 | EFO_0001666 | I71.9 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | 1 | — | — | — | 1 |
Show 11 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 1 | — | — | — | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | — | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | — | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | 1 | — | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | — | — | — | — | 1 |
| Pulmonary fibrosis | D011658 | — | — | 1 | — | — | — | — | 1 |
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | 1 | — | — | — | — | 1 |
| Pulmonary alveolar proteinosis | D011649 | HP_0006517 | J84.01 | 1 | — | — | — | — | 1 |
Show 15 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 2 | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | — | — | — | 1 | 1 |
| Wound healing | D014945 | GO_0042060 | — | — | — | — | — | 1 | 1 |
| Vitiligo | D014820 | EFO_0004208 | L80 | — | — | — | — | 1 | 1 |
| Facial injuries | D005151 | — | S09.93 | — | — | — | — | 1 | 1 |
| Necrosis | D009336 | — | — | — | — | — | — | 1 | 1 |
| Hereditary corneal dystrophies | D003317 | HP_0007802 | H18.5 | — | — | — | — | 1 | 1 |
| Hernia | D006547 | HP_0100790 | K40-K46 | — | — | — | — | 1 | 1 |
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | — | — | — | 1 | 1 |
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Collagenase clostridium histolyticum |
| INN | — |
| Description | 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.
|
| Classification | Enzyme |
| Drug class | enzymes; quaternary ammonium derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 9001-12-1 |
| RxCUI | 898492 |
| ChEMBL ID | CHEMBL2108709 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00048 |
| UNII ID | — |
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Xiaflex – Auxilium Pharmaceuticals
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Estimated US medical usage
Collagenase clostridium histolyticum
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Collagenase
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Safety
Black-box Warning
Black-box warning for: Xiaflex
Adverse Events
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6,797 adverse events reported
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