Product Description
Guselkumab is a human monoclonal immunoglobulin G1 lambda (IgG1lambda) antibody that selectively binds to the p19 subunit of IL-23 (a protein involved in the inflammatory response) and inhibits its interaction with the IL-23 receptor. Guselkumab is used for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy (ultraviolet radiation treatment). (Sourced from: https://dermnetnz.org/topics/guselkumab)
Mechanisms of Action: IL23 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Vietnam
Approved Indications: Psoriasis
Known Adverse Events: Headache | Enteritis | Gastroenteritis | Anaphylaxis | Drug Hypersensitivity | Tuberculosis | Tinea | Arthralgia | Diarrhea | Signs and Symptoms, Respiratory | Herpes Simplex
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Norway, Philippines, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 73
Highest Development Phases
Phase 3: Arthritis, Juvenile|Arthritis, Psoriatic|Colitis, Ulcerative|Crohn Disease|Palmoplantar Psoriasis|Palmoplantar Pustulosis|Psoriasis|Pustular Psoriasis
Phase 2: Giant Cell Arteritis|Lichen Planus, Oral|Lupus Nephritis|Oral Ulcer|Pemphigus, Benign Familial|Pyoderma Gangrenosum|Scleroderma, Diffuse|Scleroderma, General|Scleroderma, Systemic|Skin Ulcer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2031220308 | P2 |
Recruiting |
Colitis, Ulcerative |
2033-10-12 |
|
| TRILOGY | P3 |
Recruiting |
Arthritis, Juvenile|Arthritis, Psoriatic|Crohn Disease|Colitis, Ulcerative |
2031-12-12 |
|
| CNTO1959ISD3001 | P3 |
Unknown Status |
Crohn Disease|Arthritis, Juvenile|Colitis, Ulcerative|Arthritis, Psoriatic |
2031-12-12 |
|
| jRCT2031220309 | P2 |
Recruiting |
Crohn Disease |
2030-07-18 |