QALSODY (tofersen)
QALSODY is indicated for the treatment of Amyotrophic Lateral Sclerosis.
How QALSODY Works
Tofersen is an antisense oligonucleotide that targets the biological production of the SOD1 protein. The drug works by binding to SOD1 messenger RNA (mRNA), which facilitates the degradation of the mRNA molecule. This process results in a reduction of SOD1 protein synthesis. By lowering the levels of this protein, the drug addresses the underlying genetic driver of the disease in patients with the SOD1 mutation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-04-25
- Patent Cliff
- 2035
- Routes
- INTRATHECAL
- Dosage Forms
- SOLUTION
QALSODY Approval History
What QALSODY Treats
1 indicationsQALSODY is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Amyotrophic Lateral Sclerosis
QALSODY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to QALSODY
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04856982 ATLAS | 233AS303 2020-004590-51 | Ph 3 | active not recruiting | A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation |
| NCT07294144 | US-TOF-12361 | Ph 2 | recruiting | Tofersen in Non-SOD1 ALS |
| NCT07223723 | 233AS402 | Ph 4 | recruiting | A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS) |
| NCT03070119 results posted | 233AS102 2016-003225-41 | Ph 3 | completed | Long-Term Evaluation of BIIB067 (Tofersen) |
| NCT02623699 VALOR (Part C) results posted | 233AS101 2015-004098-33 | Ph 3 | completed | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) |
| NCT03764488 | 233HV101 | Ph 1 | completed | 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
QALSODY FDA Label Details
Indications & Usage
FDA Label (PDF)QALSODY is indicated for the treatment of Amyotrophic Lateral Sclerosis.
QALSODY Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for QALSODY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 3 active patents
Trial Analysis
- • 6 total trials
- • Stage: Expansion
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment