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 | 5 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tremfya | Biologic Licensing Application | 2025-07-23 |
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
97 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 | 1 | — | 9 | 4 | 3 | 17 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | 3 | 8 | 1 | 4 | 17 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 1 | 2 | 8 | 1 | 4 | 16 |
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 | 5 | — | 1 | 7 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 3 | 4 | — | — | 6 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 3 | 4 | — | — | 6 |
| Ulcer | D014456 | MPATH_579 | — | — | 3 | 4 | — | — | 6 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 2 | — | — | 2 |
| Necrosis | D009336 | — | — | — | — | 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 | 1 | — | — | — | 2 |
| Hidradenitis | D016575 | — | — | 1 | 1 | — | — | — | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | — | 1 | — | — | — | 1 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | 1 | — | — | — | 1 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | 1 | — | — | — | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 1 | — | — | — | 1 |
| Nephritis | D009393 | — | N05 | — | 1 | — | — | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | — | — | — | 1 |
| Skin ulcer | D012883 | — | L98.4 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | — | 6 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | 1 | 2 |
| Adenomatous polyposis coli | D011125 | — | D13.91 | 1 | — | — | — | 1 | 2 |
| Nasopharyngeal neoplasms | D009303 | — | — | 1 | — | — | — | 1 | 2 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
| 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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2364648 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB11834 |
| UNII ID | 089658A12D (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Tremfya – Johnson & Johnson
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,107 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,884 adverse events reported
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