Tremfya(guselkumab)
Tremfya (guselkumab) is an antibody pharmaceutical. Guselkumab was first approved as Tremfya on 2017-07-13. It is used to treat psoriasis in the USA. It has been approved in Europe to treat psoriasis.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Tremfya
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)
Guselkumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Tremfya | guselkumab | Johnson & Johnson | N-761061 RX | 2017-07-13 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tremfya | Biologic Licensing Application | 2020-07-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psoriasis | EFO_0000676 | D011565 | L40 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1628 | Injection, guselkumab, 1 mg |
Clinical
Clinical Trials
71 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 3 | 2 | 13 | 7 | 4 | 29 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 1 | 2 | 6 | 1 | 2 | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 2 | 3 | — | 1 | 5 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 3 | 2 | — | — | 4 |
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | — | — | 1 | — | — | 1 |
| Allergic contact dermatitis | D017449 | L23 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hidradenitis suppurativa | D017497 | L73.2 | 1 | 2 | — | — | — | 3 | |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | — | 1 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | 1 | — | — | — | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | 1 | — | — | — | 1 | |
| Pityriasis rubra pilaris | D010916 | L44.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 7 | — | — | — | — | 7 | ||
| Adenomatous polyposis coli | D011125 | 1 | — | — | — | 1 | 2 | ||
| Alcoholic liver diseases | D008108 | EFO_0008573 | K70 | 1 | — | — | — | — | 1 |
| Celiac disease | D002446 | EFO_0001060 | K90.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GUSELKUMAB |
| INN | guselkumab |
| Description | Guselkumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1350289-85-8 |
| RxCUI | 1928588 |
| ChEMBL ID | CHEMBL2364648 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB11834 |
| UNII ID | 089658A12D (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tremfya - Johnson & Johnson
$
€
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,758 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,742 adverse events reported
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