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항목
AntibodyCurated CoreFDAApproved
ustekinumab (Stelara, Wezlana)
Johnson & Johnson·IL-12 / IL-23 (p40)
195 trials·t½ 19 h
Overview
Program
Stelara (ustekinumab)
Overview
Company
Johnson & Johnson
Overview
Modality
ANTIBODY
Overview
Target
IL-12 / IL-23 (p40)
Overview
Indication
Psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Novel therapeutic avenues, including TYK2 and HDAC inhibitors, as well as nanotechnology-based delivery systems, show encoura
Positioning
Known limitation
IL-23 axis escape, anti-drug antibodies, and non-IL-12/23 inflammation.
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.
MoA
Biomarker
biomarkers but require external validation in independent cohorts
PK/PD
Half-life
19 h
PK/PD
Species
Mouse, Skin clearance (PASI75/90), endoscopic response in IBD
PK/PD
Animal (cat.)
Mouse
PK/PD
Experiment
Pharmacokinetic
Toxicology
Species
Cynomolgus monkey, Mouse
Toxicology
Major finding
Infections, reversible posterior leukoencephalopathy syndrome (rare), hypersensitivity.
Toxicology
CRS
N/A
Clinical
Safety signal
Infections, reversible posterior leukoencephalopathy syndrome (rare), hypersensitivity.
Clinical
Selected reported efficacy
PASI75 67%
Clinical
PASI75
67%
Clinical
Result source
PHOENIX
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
PHOENIX