Regranex(becaplermin)
Regranex (becaplermin) is a protein pharmaceutical. Becaplermin was first approved as Regranex on 1997-12-16. It is used to treat diabetic neuropathies in the USA. It has been approved in Europe to treat skin ulcer and wound healing.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Regranex
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)
Becaplermin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Regranex | becaplermin | Smith+Nephew | N-103691 RX | 1997-12-16 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| regranex | Biologic Licensing Application | 2023-12-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| diabetic neuropathies | EFO_1000783 | D003929 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AD: Other agents for local oral treatment in atc
— A01AD08: Becaplermin
D: Dermatologicals
— D03: Preparations for treatment of wounds and ulcers
— D03A: Cicatrizants
— D03AX: Other cicatrizants in atc
— D03AX06: Becaplermin
HCPCS
Code | Description |
|---|---|
| S0157 | Becaplermin gel 0.01%, 0.5 gm |
Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | 1 | — | 2 | 3 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | 1 | — | 1 | 2 |
| Foot ulcer | D016523 | — | — | — | — | 1 | — | 1 | 2 |
| Ulcer | D014456 | MPATH_579 | — | — | — | 1 | — | — | 1 |
| Skin ulcer | D012883 | — | L98.4 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Burns | D002056 | — | T30.0 | — | 1 | — | — | — | 1 |
| Electric burns | D002058 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 2 | 2 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Becaplermin |
| INN | becaplermin |
| Description | Platelet-derived growth factor, B chain precursor (PDGF B-chain) (Platelet-derived growth factor beta polypeptide) |
| Classification | Protein |
| Drug class | growth factors: platelet derived growth factors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201556 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00102 |
| UNII ID | 1B56C968OA (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Becaplermin
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,721 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,119 adverse events reported
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