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Nusinersen · Spinraza, BIIB-058

Oligonucleotide (Antisense oligonucleotide) · Gene silencing: SMN2 · developed by Biogen

Approved FDA, Dec 2016

BIIB Developer

2 Registered trials

What is Nusinersen?

Nusinersen is an antisense oligonucleotide that increases exon 7 inclusion in SMN2 mRNA transcripts, promoting production of full-length SMN protein.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Spinraza, BIIB-058, ISIS 396443
Drug type: Oligonucleotide (Antisense oligonucleotide)
Targets: SMN2
Mechanism: Gene silencing: SMN2
Pathways: exon 7 inclusion in SMN2 mRNA, SMN protein production
Therapy area: Neurology
Developer: Biogen (BIIB)
FDA status: Approved as Spinraza (December 23, 2016), NDA209531 · FDA label
UNII: 5Z9SP3X666

✅ FDA-approved uses

Spinal muscular atrophy

From the indications section of the FDA label (version of Mar 31, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05067790	Phase 3	Spinal Muscular Atrophy	Active not recruiting	BIIB
NCT04317794	N/A	Muscular Atrophy, Spinal	Active not recruiting	BIIB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Muscular Atrophy, SpinalSpinal Muscular Atrophy

Other drugs acting on SMN2

Risdiplam FDA approved

More from Biogen

Dimethyl Fumarate FDA approved Diroximel Fumarate FDA approved Interferon Beta-1A FDA approved Natalizumab FDA approved Omaveloxolone FDA approved Tofersen FDA approved Zuranolone FDA approved BIIB115 Phase 1 BIIB122 Phase 3 BIIB144 Phase 1 BIIB147 Phase 1/2 Diranersen Phase 2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BIIB page.

Follow BIIB, the company behind Nusinersen

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z