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타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 다음 갱신 D-6 · 마지막 9월 2일

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항목
CGTCurated CoreFDAApproved
valoctocogene roxaparvovec (Roctavian, BMN 270, valoctocogene roxaparvovec-rvox)
BioMarin·Factor VIII (AAV5)
8 trials
Overview
Program
Roctavian (valoctocogene roxaparvovec)
Overview
Company
BioMarin
Overview
Modality
CGT
Overview
Target
Factor VIII (AAV5)
Overview
Indication
Severe hemophilia A in adults
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
First FDA-approved gene therapy for hemophilia A
Positioning
Known limitation
bypassing agents (BPAs), recombinant factor VIII (rFVIII), recombinant factor VIII Fc fusion protein (rFVIIIFc), and gene ther
Positioning
Development positioning
Gene therapy alternative to Emicizumab / FVIII prophylaxis
Technology
Vector
AAV5
MoA
Mechanism
Valoctocogene roxaparvovec (AAV5-hFVIII) provides liver-directed Factor VIII expression for severe hemophilia A.
MoA
Biomarker
FVIII activity, ABR.
PK/PD
Species
Cynomolgus monkey
PK/PD
Animal (cat.)
NHP
PK/PD
Experiment
biodistribution
Toxicology
Species
Cynomolgus monkey
Toxicology
Major finding
Hepatocellular enzyme elevations; steroid protocols
Clinical
Safety signal
Hepatocellular enzyme elevations; steroid protocols
Clinical
Program phase
APPROVED
Clinical
Trial activity
1 recruiting · 6 completed
Preclinical
Animal (cat.)
NHP