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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
delandistrogene moxeparvovec (Elevidys, SRP-9001, delandistrogene moxeparvovec-rokl)
Sarepta Therapeutics·Micro-dystrophin (AAVrh74)
12 trials
Overview
Program
Elevidys (delandistrogene moxeparvovec)
Overview
Company
Sarepta Therapeutics
Overview
Modality
CGT
Overview
Target
Micro-dystrophin (AAVrh74)
Overview
Indication
Duchenne muscular dystrophy (DMD) — ambulatory / label-expanded populations
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
Muscle-directed AAV micro-dystrophin vs exon-skipping ASOs
Positioning
Known limitation
Acute liver injury, myocarditis, immune myositis
Positioning
Development positioning
First approved AAV gene therapy for DMD in the US
Technology
Vector
AAVrh74
MoA
Mechanism
Delandistrogene moxeparvovec (AAVrh74) delivers micro-dystrophin transgene to skeletal/cardiac muscle in Duchenne muscular dystrophy ambulatory patients.
MoA
Biomarker
Micro-dystrophin expression, NSAA motor function.
PK/PD
Species
NHP, Micro-dystrophin Western blot, functional motor scores
PK/PD
Animal (cat.)
Human, NHP
PK/PD
Experiment
pd
Toxicology
Species
NHP
Toxicology
Major finding
Hepatotoxicity; immune-mediated myositis/myocarditis signals
Clinical
Safety signal
Hepatotoxicity; immune-mediated myositis/myocarditis signals
Clinical
Program phase
APPROVED
Clinical
Trial activity
4 recruiting · 6 completed