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nusinersen

Generic: NUSINERSEN SODIUM·Brand: SPINRAZA, Spinraza

nusinersen: sourced relationships with 1 company · 4 clinical trials tracked · 1 FDA decision.

nusinersen evidence translation

What we can confirm

1 FDA record · 4 tracked trials

What it means

Source-backed records connect nusinersen to BIIB; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could nusinersen → BIIB affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Related indications

spinal muscular atrophyMuscular Atrophy, Spinal

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
BIOGEN INC. (BIIB)
Reported 2016-12-23 · Current development: unknownSource
spinal muscular atrophy
Approved
Clinical Trial Registry Records (4)

A Phase 2, Double-Blind Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Apitegromab in Subjects <2 Years Old With Spinal Muscular Atrophy (SMA)

NCT07047144Registry updated 2026-05-01·Phase 2
Recruiting

Primary endpoint: Evaluate the PK of apitegromab in subjects <2 years old with SMA

InterventionalRandomizedquadruple52 targetStarted 2025-09Completion 2029-0325 sites · Belgium, France, Italy, Netherlands…Scholar Rock, Inc.

An Open Label Study to Assess the Pharmacokinetic Profile of Nusinersen (BIIB058) Administered Via the ThecaFlex DRx™ System (PIERRE-PK)

NCT06555419Registry updated 2026-09-03·Phase 1·BIIB
Recruiting

Primary endpoint: Maximum Observed Concentration (Cmax) of Nusinersen Delivered via Standard LP and via ThecaFlex DRx System

Interventionalopen78 targetStarted 2025-01Completion 2027-0921 sites · France, Germany, Italy, Poland…Biogen

A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients With Spinal Muscular Atrophy Previously Treated With Risdiplam

NCT05067790Registry updated 2026-05-22·Phase 3·BIIB
Active, not recruiting

Primary endpoint: Change in Total Revised Upper Limb Module (RULM) Score

Interventionalopen45 targetStarted 2022-01Completion 2027-0922 sites · Germany, Hungary, Italy, Japan…Biogen

A Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen

NCT04729907Registry updated 2026-08-11·Phase 3·BIIB
Completed

Primary endpoint: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Interventionalquadruple115 enrolledStarted 2021-04Completion 2026-0739 sites · Brazil, Canada, Chile, China…Biogen
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients ( 1 )(BIIB)FDA ↗
NDA209531Type 1 - New Molecular EntityOrphan DrugPriorityOtherSolution

Frequently asked questions

Which companies have sourced relationships with nusinersen?

nusinersen has dated SEC/FDA relationship records for BIOGEN INC..

How many clinical trials involve nusinersen?

BioSniper tracks 4 clinical trials involving nusinersen.

What is nusinersen's latest FDA decision?

The most recent tracked FDA decision for nusinersen is Approval for 1 INDICATIONS AND USAGE SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients ( 1 ), dated December 23, 2016.