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항목
AntibodyCurated CoreFDAApproved
tezepelumab (Tezspire, AMG 157, MEDI9929, tezepelumab-ekko)
AstraZeneca / Amgen·TSLP (thymic stromal lymphopoietin…
47 trials·t½ ~26 days
Overview
Program
Tezspire (tezepelumab)
Overview
Company
AstraZeneca / Amgen
Overview
Modality
ANTIBODY
Overview
Target
TSLP (thymic stromal lymphopoietin)
Overview
Indication
Severe asthma add-on maintenance, chronic rhinosinusitis with nasal polyps
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
Acting upstream of IL-4/IL-5/IL-13 covers both eosinophilic and low-eosinophil asthma, unlike downstream type-2 blockers.
Positioning
Known limitation
Non-inflammatory structural airway disease does not respond to cytokine blockade.
Positioning
Development positioning
The phenotype-agnostic option versus Dupixent, Nucala, and Fasenra.
MoA
Mechanism
Neutralizes epithelial-derived TSLP, blocking the alarmin signal that initiates dendritic-cell and ILC2 activation and downstream type-2 and non-type-2 airway inflammation.
MoA
Biomarker
Blood eosinophils, FeNO, total IgE fall on treatment but none is required for eligibility.
PK/PD
Half-life
~26 days
PK/PD
Species
Cynomolgus monkey, Annualized exacerbation rate, pre-bronchodilator FEV1, FeNO, blood eosinophils
PK/PD
Animal (cat.)
Human, NHP
PK/PD
Experiment
Pharmacokinetic
Toxicology
Species
Cynomolgus monkey
Toxicology
Major finding
Generally well tolerated — pharyngitis, arthralgia, back pain, and injection-site reactions. Hypersensitivity occurs rarely; live vaccines should be considered before starting.
Toxicology
CRS
N/A
Clinical
Safety signal
Generally well tolerated — pharyngitis, arthralgia, back pain, and injection-site reactions. Hypersensitivity occurs rarely; live vaccines should be considered before starting.
Clinical
Selected reported efficacy
56%
Clinical
Result source
NAVIGATOR (NCT03347279)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT03347279
Preclinical
Animal (cat.)
NHP