SPINRAZA

PeakRNA

nusinersen

NDAINTRATHECALSOLUTIONPriority Review
Approved
Dec 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Pharmacologic Class:

Survival Motor Neuron-2-directed RNA Interaction

Clinical Trials (5)

NCT06955897N/ARecruiting

Characterizing Perceived Physical Fatigability in Nusinersen-treated SMA

Started Apr 2025
45 enrolled
Spinal Muscular Atrophy
NCT06555419Phase 1Recruiting

A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)

Started Jan 2025
58 enrolled
Muscular Atrophy, Spinal
NCT05789758N/ARecruiting

A Study to Learn How Nusinersen (Spinraza) Affects Participants With Spinal Muscular Atrophy (SMA) Who Took it Before or During Pregnancy And About The Health of Their Babies

Started Dec 2023
20 enrolled
Muscular Atrophy, Spinal
NCT05386680Phase 3Completed

Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam

Started Jan 2023
27 enrolled
Spinal Muscular Atrophy
NCT05522361Phase 4Active Not Recruiting

Risdiplam in Patients With Spinal Muscular Atrophy Previously Treated With Nusinersen

Started Nov 2022
10 enrolled
Spinal Muscular Atrophy

Loss of Exclusivity

LOE Date
Mar 4, 2036
121 months away
Patent Expiry
Mar 4, 2036

Patent Records (5)

Patent #ExpiryTypeUse Code
7838657
Jul 11, 2027
Substance
9717750
Jun 17, 2030
U-1943
8980853
Nov 24, 2030
U-1941
8361977
Dec 23, 2030
SubstanceProduct
9926559
Jan 9, 2034
U-1943