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항목
AntibodyCurated CoreFDAApproved
guselkumab (Tremfya, CNTO 1959)
Johnson & Johnson·IL-23 p19
87 trials·t½ ~15–18 days
Overview
Program
Tremfya (guselkumab)
Overview
Company
Johnson & Johnson
Overview
Modality
ANTIBODY
Overview
Target
IL-23 p19
Overview
Indication
Plaque psoriasis, psoriatic arthritis, ulcerative colitis, Crohn's disease
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
Leaving 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
Anti-drug antibodies are rare; non-IL-23-driven fibrostenotic disease does not respond.
Positioning
Development positioning
IL-23 class benchmark alongside Skyrizi, now with the broadest IBD label progression.
MoA
Mechanism
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
PASI/IGA in psoriasis, ACR20 in PsA, endoscopic improvement and fecal calprotectin in IBD.
PK/PD
Half-life
~15–18 days
PK/PD
Species
Cynomolgus monkey, PASI 90/100, ACR20/50, endoscopic remission, serum IL-17A/IL-22
PK/PD
Animal (cat.)
Human, NHP
PK/PD
Experiment
Pharmacokinetic
Toxicology
Species
Mouse, Pig
Toxicology
Major finding
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/A
Clinical
Safety signal
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
APPROVED
Clinical
Trial activity
No active/completed counts
Preclinical
Animal (cat.)
Mouse