NDAINTRATHECALSOLUTIONPriority Review
Approved
Apr 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
Priority Review
QALSODY (tofersen) by Biogen. Approved for amyotrophic lateral sclerosis. First approved in 2023.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QALSODY (tofersen) is an antisense oligonucleotide designed to reduce production of superoxide dismutase 1 (SOD1) protein in patients with SOD1-ALS. It is administered intrathecally to target the central nervous system directly. The drug represents a novel mechanism for treating a subset of ALS patients carrying SOD1 mutations.
$0.454MPart D
GrowthStable
8.9 years to LOEEarly-stage commercial launch with significant growth potential as awareness and patient identification expand among a rare disease population.
Mechanism of Action
Pharmacologic Class:
Antisense Oligonucleotide
Indications (1)
Clinical Trials (8)
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD-1) Amyotrophic Lateral Sclerosis (ALS)
Started Jan 2026
125 enrolled
Amyotrophic Lateral Sclerosis
Tofersen in Non-SOD1 ALS
Started Dec 2025
30 enrolled
ALS (Amyotrophic Lateral Sclerosis)
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS)
Started Dec 2025
12 enrolled
Amyotrophic Lateral Sclerosis
A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation
Started May 2021
158 enrolled
Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation
A Study to Evaluate Safety, Tolerability, and Distribution of a Microdose of Radiolabeled BIIB067 (99mTc-MAG3-BIIB067) Co-administered With BIIB067 (Tofersen) to Healthy Adults
Started Dec 2018
8 enrolled
Healthy Volunteers
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.