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
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 | 2019-08-01 |
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
805 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 5 | 40 | 12 | 7 | 64 |
| Sepsis | D018805 | A41.9 | 2 | 14 | 10 | 3 | 6 | 32 | |
| Colonoscopy | D003113 | — | 2 | 8 | 8 | 14 | 32 | ||
| Covid-19 | D000086382 | U07.1 | 3 | 11 | 10 | 2 | 9 | 31 | |
| Constipation | D003248 | HP_0002019 | K59.0 | — | 4 | 3 | 18 | 1 | 25 |
| Septic shock | D012772 | A48.3 | 3 | 11 | 10 | 1 | 3 | 24 | |
| Colorectal neoplasms | D015179 | 3 | 5 | 5 | 2 | 3 | 16 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 2 | 1 | 2 | 8 | 15 |
| Dry eye syndromes | D015352 | H04.12 | — | 2 | — | 5 | 7 | 14 | |
| Colonic neoplasms | D003110 | C18 | 1 | 2 | 4 | 1 | 5 | 12 |
Show 57 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 9 | — | 2 | — | 8 | 19 | ||
| Oxidative stress | D018384 | EFO_1001905 | — | 1 | 4 | — | 6 | 11 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 1 | 2 | — | 3 | 7 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | 2 | — | 4 | 7 | |
| Iron deficiencies | D000090463 | E61.1 | — | — | 1 | — | 5 | 6 | |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 1 | 1 | 3 | — | 1 | 6 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 2 | 2 | — | 1 | 5 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 2 | 2 | — | — | 5 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 2 | 2 | — | 1 | 4 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | 1 | — | 2 | 4 |
Show 49 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 11 | 11 | — | — | — | 18 |
| Ascorbic acid deficiency | D001206 | EFO_1000822 | E54 | 3 | 3 | — | — | 6 | 11 |
| Multiple myeloma | D009101 | C90.0 | 4 | 7 | — | — | — | 9 | |
| Myelodysplastic syndromes | D009190 | D46 | — | 6 | — | — | 2 | 8 | |
| Plasma cell neoplasms | D054219 | 2 | 5 | — | — | — | 6 | ||
| Glioblastoma | D005909 | EFO_0000515 | 4 | 1 | — | — | 1 | 6 | |
| Sarcoma | D012509 | 4 | 3 | — | — | — | 6 | ||
| Myeloid leukemia acute | D015470 | C92.0 | — | 4 | — | — | 1 | 5 | |
| Prostatic neoplasms | D011471 | C61 | — | 3 | — | — | 1 | 4 | |
| Non-small-cell lung carcinoma | D002289 | 2 | 4 | — | — | — | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | — | 2 | 3 |
| Pharmacokinetics | D010599 | 2 | — | — | — | 1 | 3 | ||
| Burns | D002056 | T30.0 | 1 | — | — | — | 2 | 3 | |
| Heart disease risk factors | D000082742 | 1 | — | — | — | 2 | 3 | ||
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | 1 | — | — | — | 1 | 2 |
| Vascular stiffness | D059289 | 1 | — | — | — | 1 | 2 | ||
| Peripheral arterial disease | D058729 | EFO_0004265 | 2 | — | — | — | — | 2 | |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | 1 | — | — | — | 1 | 2 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | — | — | — | 1 | 2 |
| Hyperuricemia | D033461 | 1 | — | — | — | 1 | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | F51.01 | — | — | — | — | 2 | 2 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | — | — | — | 2 | 2 |
| Replacement arthroplasty knee | D019645 | — | — | — | — | 2 | 2 | ||
| Musculoskeletal diseases | D009140 | — | — | — | — | 2 | 2 | ||
| Wound infection | D014946 | — | — | — | — | 2 | 2 | ||
| Aplastic anemia | D000741 | HP_0001915 | D61.9 | — | — | — | — | 1 | 1 |
| Paroxysmal hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | — | — | — | 1 | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | — | — | 1 | 1 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
Show 83 more
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 | 165101-51-9 |
| RxCUI | 115238 |
| ChEMBL ID | CHEMBL1201556 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00102 |
| UNII ID | 1B56C968OA (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,420 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,810 adverse events reported
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