Xiaflex, Xiapex(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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| musculoskeletal diseases | D009140 |
| urogenital diseases | D000091642 |
| skin and connective tissue diseases | D017437 |
| wounds and injuries | D014947 |
Trade Name
FDA
EMA
Qwo, Xiaflex
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 clostridium histolyticum
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Xiaflex | collagenase clostridium histolyticum | Auxilium Pharmaceuticals | N-125338 RX | 2010-02-02 | 1 products |
Collagenase clostridium histolyticum-aaes
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Qwo | collagenase clostridium histolyticum-aaes | Endo | N-761146 RX | 2020-07-06 | 2 products |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| burns | — | D002056 | T30.0 |
| dupuytren contracture | EFO_0004229 | D004387 | M72.0 |
| penile induration | — | D010411 | N48.6 |
| 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
No data
HCPCS
No data
Clinical
Clinical Trials
61 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 2 | 8 | 1 | 1 | 10 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | 3 | 3 | 1 | 8 |
| Infections | D007239 | EFO_0000544 | — | — | 4 | 1 | 1 | 6 | |
| Acinetobacter infections | D000151 | EFO_1000792 | — | — | — | 1 | 3 | 4 | |
| Bacterial infections | D001424 | A49 | — | — | 2 | 1 | 1 | 4 | |
| Gram-negative bacterial infections | D016905 | — | — | — | 3 | — | 3 | ||
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | 1 | 1 | — | 2 | |
| Critical illness | D016638 | 1 | — | — | 1 | — | 2 | ||
| Communicable diseases | D003141 | — | — | 1 | 1 | — | 2 | ||
| Cross infection | D003428 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | 2 | — | 1 | 4 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | 1 | 2 | — | 1 | 3 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | 3 | ||
| Sepsis | D018805 | A41.9 | — | — | 1 | — | 1 | 2 | |
| Healthcare-associated pneumonia | D000077299 | — | 1 | 1 | — | — | 2 | ||
| Iatrogenic disease | D007049 | — | — | 1 | — | — | 1 | ||
| Bronchitis | D001991 | J40 | — | — | 1 | — | — | 1 | |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | 1 | — | — | 1 |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | — | 1 | — | — | 1 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pseudomonas aeruginosa | D011550 | NCBITaxon_287 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumococcal infections | D011008 | EFO_0000772 | J13 | 1 | — | — | — | — | 1 |
| Pseudomonas infections | D011552 | EFO_0001076 | 1 | — | — | — | — | 1 | |
| Gram-negative bacteria | D006090 | 1 | — | — | — | — | 1 | ||
| Hepatic encephalopathy | D006501 | K72.91 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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 | — |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
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Financial
Xiaflex - Auxilium Pharmaceuticals
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Trends
PubMed Central
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Additional graphs summarizing 688 documents
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Safety
Black-box Warning
Black-box warning for: Xiaflex
Adverse Events
Top Adverse Reactions
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675 adverse events reported
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