Treatment

FDA-Approved ALS Treatments

Current FDA-approved ALS disease treatments, including the SOD1-specific indication for tofersen.

Treatment records

FDA-Approved ALS Treatments

3 sourced records.

FDA APPROVED

riluzole

Brand / formulation: Rilutek, Tiglutik, Exservan

A non-gene-specific oral ALS disease-targeting treatment available in tablet, suspension, and oral-film formulations.

Gene requirement
Not gene-specific / no known gene requirement
Category
ALS disease-targeting treatment
Regulatory status
FDA APPROVED · 12-12-1995
Country / availability
United States
Route
Oral tablet, Oral suspension, Oral film
Purpose
ALS disease progression
View treatment detailsU.S. Food and Drug Administration source ↗U.S. Food and Drug Administration source ↗U.S. Food and Drug Administration source ↗Mayo Clinic source ↗

FDA APPROVED

edaravone

Brand / formulation: Radicava, Radicava ORS

A non-gene-specific ALS disease-targeting treatment with intravenous and oral-suspension formulations.

Gene requirement
Not gene-specific / no known gene requirement
Category
ALS disease-targeting treatment
Regulatory status
FDA APPROVED · 05-05-2017 (Radicava); 05-12-2022 (Radicava ORS)
Country / availability
United States
Route
Intravenous infusion, Oral suspension
Purpose
ALS disease progression
View treatment detailsU.S. Food and Drug Administration source ↗U.S. Food and Drug Administration source ↗Mayo Clinic source ↗

FDA APPROVED — GENE-SPECIFIC

tofersen

Brand / formulation: Qalsody

A gene-specific antisense treatment for adults with SOD1-associated ALS. It is not approved as a general ALS treatment or for other ALS genes.

Gene requirement
SOD1
Category
ALS disease-targeting treatment
Regulatory status
FDA APPROVED — GENE-SPECIFIC · 04-25-2023
Country / availability
United States
Route
Intrathecal spinal injection / lumbar puncture
Purpose
ALS disease progression, Gene-specific ALS
View treatment detailsU.S. Food and Drug Administration source ↗U.S. Food and Drug Administration source ↗U.S. Food and Drug Administration source ↗Mayo Clinic source ↗

Sources & Further Reading

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Treatment information is provided for education and navigation and does not replace medical advice. Whether a treatment is appropriate depends on the individual’s diagnosis, genetic status, symptoms, health status, and other clinical factors. Treatment decisions should be made with the person’s ALS care team.

Treatment records last verified: 09-30-2026