Overview
Guselkumab is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody that selectively blocks interleukin-23. IL-23 is an inflammatory cytokine that activates the CD4+ T-helper (Th17) cell pathway to mediate the inflammatory cascade that induces psoriatic plaque formation . In clinical trials, guselkumab demonstrated improved skin clearance and symptomatic improvements in dermatological manifestations of psoriasis. Developed by Janssen, the subcutenous injection form of guselkumab was approved in July 2017 under the market name Tremfya for the treatment of adult patients with moderate-to-severe plaque psoriasis.
Indication
Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Associated Conditions
- Severe Plaque psoriasis
- Moderate Plaque psoriasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/16 | Phase 4 | Recruiting | |||
2025/04/08 | Phase 4 | Not yet recruiting | |||
2024/10/29 | Phase 3 | Recruiting | |||
2024/10/21 | Phase 2 | Recruiting | |||
2024/09/19 | Not Applicable | Recruiting | |||
2024/08/20 | Phase 2 | Not yet recruiting | |||
2024/05/10 | Phase 3 | Recruiting | |||
2024/02/15 | Phase 3 | Recruiting | |||
2023/09/15 | Phase 3 | Completed | |||
2023/06/28 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Biotech, Inc. | 57894-640 | SUBCUTANEOUS | 100 mg in 1 mL | 11/9/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/10/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML | SIN15508P | INJECTION, SOLUTION | 100mg/mL | 6/21/2018 | |
| TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML | SIN15876P | INJECTION, SOLUTION | 100mg/ml | 1/17/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Guselkumab Injection | 国药准字SJ20190044 | 生物制品 | 注射剂 | 9/2/2024 | |
| Guselkumab Injection | 国药准字SJ20202004 | 生物制品 | 注射剂 | 9/2/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TREMFYA guselkumab 100 mg solution for injection, prefilled syringe | 286020 | Medicine | A | 3/15/2018 | |
| TREMFYA guselkumab (rch) 100 mg solution for injection pre-filled pen (One-Press (R) patient controlled injector) | 321410 | Medicine | A | 5/13/2020 |
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