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항목
AntibodyCurated CoreFDAstaleApproved
ustekinumab (Stelara, Wezlana)
Johnson & Johnson·IL-12 / IL-23 (p40)
195 trials
AntibodyCurated CoreFDAstaleApproved
guselkumab (Tremfya, CNTO 1959)
Johnson & Johnson·IL-23 p19
87 trials
Overview
Program
Stelara (ustekinumab)Tremfya (guselkumab)
Overview
Company
Johnson & JohnsonJohnson & Johnson
Overview
Modality
ANTIBODYANTIBODY
Overview
Target
IL-12 / IL-23 (p40)IL-23 p19
Overview
Indication
Psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitisPlaque psoriasis, psoriatic arthritis, ulcerative colitis, Crohn's disease
Overview
Phase
APPROVEDAPPROVED
Overview
Status
APPROVEDAPPROVED
Overview
Content status
Curated CoreCurated Core
Overview
Data Confidence
Editorial scope · Curated CoreEditorial scope · Curated Core
Overview
Development Signal
Development Signal · EstablishedDevelopment Signal · Established
Overview
Approval status
FDA approvedFDA approved
Positioning
Key differentiator
Novel therapeutic avenues, including TYK2 and HDAC inhibitors, as well as nanotechnology-based delivery systems, show encouraLeaving IL-12 intact preserves Th1 antimicrobial immunity while shutting down the Th17 axis, which is why durability is high and infection signals are low.
Positioning
Known limitation
IL-23 axis escape, anti-drug antibodies, and non-IL-12/23 inflammation.Anti-drug antibodies are rare; non-IL-23-driven fibrostenotic disease does not respond.
Positioning
Development positioning
—1L–2L biologic across dermatology, rheumatology, and gastroenterology
MoA
Mechanism
Ustekinumab binds the p40 subunit shared by IL-12 and IL-23, preventing their interaction with IL-12Rβ1 receptor and downstream Th1/Th17 differentiation and cytokine production.Neutralizes IL-23 by binding p19, blocking IL-23R signaling and downstream Th17/Th22 differentiation, IL-17 production, and tissue inflammation in skin, joints, and gut mucosa.
MoA
Biomarker
biomarkers but require external validation in independent cohortsPASI/IGA in psoriasis, ACR20 in PsA, endoscopic improvement and fecal calprotectin in IBD.
Toxicology
Species
Cynomolgus monkey, MousePig
Toxicology
Major finding
Infections, reversible posterior leukoencephalopathy syndrome (rare), hypersensitivity.Upper respiratory infection, headache, and injection-site reactions dominate. Serious infection and malignancy signals have stayed low across long-term psoriasis follow-up.
Toxicology
CRS
N/AN/A
Clinical
Safety signal
Infections, reversible posterior leukoencephalopathy syndrome (rare), hypersensitivity.Upper respiratory infection, headache, and injection-site reactions dominate. Serious infection and malignancy signals have stayed low across long-term psoriasis follow-up.
Clinical
Program phase
APPROVEDAPPROVED
Clinical
Trial activity
No active/completed countsNo active/completed counts