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Nusinersen

Alternative Names: nusinersen, spinraza, isis-396443, isis396443, isis 396443
Latest Update: 2025-01-23
Latest Update Note: News Article

Product Description

recently approved antisense oligonucleotide for spinal muscular atrophy (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5858681/)

Mechanisms of Action: mRNA Agonist

Novel Mechanism: No

Modality: Nucleic Acid

Route of Administration: Injection

FDA Designation: None *

Approval Status: Approved

Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay

Approved Indications: Muscular Atrophy, Spinal | Muscular Atrophy

Known Adverse Events: Constipation

Company: Biogen
Company Location: CAMBRIDGE MA 02142
Company CEO: Michel Vounatsos
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Nusinersen

Countries in Clinic: Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Mexico, Netherlands, Poland, Qatar, Russia, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States

Active Clinical Trial Count: 13

Highest Development Phases

Phase 3: Muscular Atrophy, Spinal

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

jRCT2051230096

P3

Not yet recruiting

Muscular Atrophy, Spinal

2030-07-31

232SM303

P3

Unknown Status

Muscular Atrophy, Spinal

2027-07-22

ASCEND

P3

Recruiting

Muscular Atrophy, Spinal

2027-06-14

95%

jRCT2031220035

P3

Recruiting

Muscular Atrophy, Spinal

2026-11-30

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