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Guselkumab

Generic Name
Guselkumab
Brand Names
Tremfya
Drug Type
Biotech
CAS Number
1350289-85-8
Unique Ingredient Identifier
089658A12D

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.

Background

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

FDA Approved Products

Tremfya
Manufacturer:Janssen Biotech, Inc.
Route:SUBCUTANEOUS
Strength:100 mg in 1 mL
Approved: 2023/11/09
NDC:57894-640

Singapore Approved Products

TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML
Manufacturer:Cilag AG
Form:INJECTION, SOLUTION
Strength:100mg/mL
Online:Yes
Approved: 2018/06/21
Approval:SIN15508P
TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
Manufacturer:Cilag AG
Form:INJECTION, SOLUTION
Strength:100mg/ml
Online:Yes
Approved: 2020/01/17
Approval:SIN15876P

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