Nusinersen Sodium

Treats spinal muscular atrophy (SMA). Sold as Spinraza. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Nusinersen Sodium (sold as Spinraza), first approved Dec 23, 2016, with 3 new uses approved and 0 published complete response letters.

First approved: Dec 23, 2016
Applications: 1
New uses approved: 3
Complete response letters: 0
First approved in the EU: May 30, 2017
First approved in Japan: Jul 3, 2017

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of spinal muscular atrophyBiogen, Inc · designated Apr 18, 2011 · approved Dec 23, 2016

Approvals in the EU (EMA)

First approved in the EU 5 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Spinraza, new substanceBiogen Netherlands B.V. · May 30, 2017

Approvals in Japan (PMDA)

First approved in Japan 6 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Spinraza Intrathecal, new approvalDrugs with a new dosage in an additional dosage form indicated for the treatment of spinal muscular atrophy. · Biogen Japan Ltd. · Sep 19, 2025
Spinraza IntrathecalA drug with a new indication for the treatment of spinal muscular atrophy without any clinical manifestations that is predicted to develop with genetic test. · Biogen Japan Ltd. · Mar 28, 2022
Spinraza Intrathecal injectionA drug with a revised indication and a new dosage for the treatment of spinal muscular atrophy. · Biogen Japan Ltd. · Sep 22, 2017 · Review report
Spinraza Intrathecal injection, new ingredientA drug with a new active ingredient indicated for the treatment of infantile spinal muscular atrophy. · Biogen Japan Ltd. · Jul 3, 2017 · Review report

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
A Study of the Safety of Nusinersen (Spinraza®) and Its Effects on Motor Function in Koreans Living With SMA Treated During Their Usual Medical CareMuscular Atrophy, Spinal · Biogen	—	Active, not recruiting	Mar 23, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 23, 2016	SpinrazaNDA 209531 · New molecular entity	Biogen	11	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA