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Onasemnogene Abeparvovec-xioi

Phase 3
NOVARTIS AG (NVSEF)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

2

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Spinal Muscular Atrophy Type I

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Drug Information

Target Indication

Spinal Muscular Atrophy Type I

Clinical Trial

NCT03837184

Last updated: 2/14/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA6/30/2026

Itvisma

Itvisma is indicated for the treatment of 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene in patients 2 years of age and older.

View on EMA
EMA5/18/2020

Zolgensma

Zolgensma is indicated for the treatment of: patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.

OrphanConditionalPRIME
View on EMA
Drug Science
Mechanism of action & safety profile
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