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API CSV25행 · 1개 프로그램

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항목
AntibodyLimited DatastaleApproved
Omalizumab (Omalizumab)
Roche / Novartis·Persistent Allergic Asthma
89 trials·t½ 26 h
Overview
Program
Omalizumab
Overview
Company
Roche / Novartis
Overview
Modality
ANTIBODY
Overview
Target
Persistent Allergic Asthma
Overview
Indication
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP); Chronic Rhinosinusitis (CRS)
Overview
Phase
APPROVED
Overview
Status
ACTIVE
Overview
Content status
Limited Data
Overview
Data Confidence
Data Confidence · Low
Overview
Development Signal
Development Signal · Established
Overview
Approval status
Approved (flag incomplete)
MoA
Mechanism
targeting specific inflammatory pathway
MoA
Biomarker
biomarkers and clinical characteristics and highlight the need for standardized, methodologically rigorous fu
PK/PD
Half-life
26 h
PK/PD
Species
Hamster
PK/PD
Animal (cat.)
Unknown
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Hamster
Toxicology
Animal (cat.)
Unknown
Toxicology
Major finding
Safety and effectiveness of omalizumab for chronic spontaneous urticaria inadequately controlled with H1 antihistamines in Chinese adolescents: a real-world, prospective, multicenter study.. Chronic spontaneous urticaria (CSU) is a burdensome skin disorder that may remain inadequately controlled with standard H1 antihistamines (H1 AHs). Evidence on adolescents with CSU is limited. This 16-week stu…
Clinical
Safety signal
Safety and effectiveness of omalizumab for chronic spontaneous urticaria inadequately controlled with H1 antihistamines in Chinese adolescents: a real-world, prospective, multicenter study.. Chronic spontaneous urticaria (CSU) is a burdensome skin disorder that may remain inadequately controlled with standard H1 antihistamines (H1 AHs). Evidence on adolescents with CSU is limited. This 16-week stu…
Clinical
Selected reported efficacy
0.13%
Clinical
Result source
ClinicalTrials.gov NCT03478930
Clinical
Program phase
APPROVED
Clinical
Trial ref
NCT03478930