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 | — |
| skin ulcer | HP_0200042 | D012883 | L98.4 |
| wound healing | GO_0042060 | D014945 | — |
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
40 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gingival recession | D005889 | — | K06.0 | — | — | — | 1 | 2 | 3 |
| Peri-implantitis | D057873 | EFO_1001390 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic foot | D017719 | EFO_1001459 | — | 3 | 2 | 3 | — | 4 | 11 |
| Foot ulcer | D016523 | — | — | 3 | 2 | 3 | — | 3 | 10 |
| Ulcer | D014456 | MPATH_579 | — | 3 | 2 | 4 | — | 1 | 9 |
| Varicose ulcer | D014647 | — | — | 1 | — | 1 | — | — | 2 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | 1 | — | 1 | 2 |
| Leg ulcer | D007871 | — | — | — | — | 1 | — | — | 1 |
| Skin ulcer | D012883 | HP_0200042 | L98.4 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 2 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Leiomyosarcoma | D007890 | — | — | — | 1 | — | — | — | 1 |
| Periodontal guided tissue regeneration | D016557 | — | — | — | 1 | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 1 | — | — | — | 1 |
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | — | 1 | — | — | — | 1 |
| Burns | D002056 | — | T30.0 | — | 1 | — | — | — | 1 |
| Electric burns | D002058 | — | — | — | 1 | — | — | — | 1 |
| Periodontal diseases | D010510 | — | K05.6 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | — | — | — | 2 | 3 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | — | — | — | — | 1 |
| Foot injuries | D018409 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 3 | 3 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | — | — | — | 1 | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | — | — | 1 | 1 |
| Joint diseases | D007592 | HP_0003040 | M12.9 | — | — | — | — | 1 | 1 |
| Congenital hand deformities | D006228 | — | — | — | — | — | — | 1 | 1 |
| Cartilage diseases | D002357 | EFO_0005802 | M91-M94 | — | — | — | — | 1 | 1 |
| Rotator cuff injuries | D000070636 | — | M75.1 | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
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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) |
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Estimated US medical usage
Becaplermin
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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2,119 adverse events reported
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