FDA-Approved Drugs for Treating ALS
Studies all over the world, many funded by The ALS Association, are ongoing to develop more treatments and a cure for ALS. There are currently seven drugs approved by the U.S. Food and Drug Administration (FDA) to treat ALS and its symptoms: Qalsody, RELYVRIO, Radicava, Rilutek, Tiglutik, Exservan and Nuedexta.
Please consult your doctor or health care professional about which ones may be right for you.
Qalsody, also known as tofersen or BIIB067, was developed to treat ALS associated with a mutation in the superoxide dismutase 1 (SOD1) gene. The FDA approved Qalsody for use to treat SOD1-ALS in 2023. Learn more.
RELYVRIO is a combination of two drugs, sodium phenylbutyrate and taurursodiol, which act to prevent nerve cell death by blocking stress signals in cells. The FDA approved RELYVRIO for use to treat ALS in 2022. Learn more.
The FDA approved Radicava™ in 2017, making it the first new treatment specifically for ALS in 22 years. An oral formulation was approved in 2022. Learn more.
Rilutek (riluzole, now generic)
This was the first FDA-approved drug available to treat ALS — in 1995. It inhibits glutamate release and prolongs life approximately three months. Riluzole is the generic name of Rilutek.
Tiglutik (thickened riluzole)
The first and only thickened liquid form of riluzole, Tiglutik was approved by the FDA in September 2018. This formulation contrasts with the oral pill form of riluzole that has been on the market for ALS for more than 20 years. It is designed to avoid potential problems of crushing tablets. Learn more.
Exservan™ (riluzole oral film)
An oral film formulation of riluzole, Exservan was approved by the FDA in November 2019. This formulation contrasts with the oral pill form of riluzole that has been on the market for ALS for more than 20 years and developed for patients with severe swallowing difficulties. The oral film is placed on top of the patient’s tongue and dissolves bypassing the need to swallow a pill or liquid.
Indicated for the treatment of pseudobulbar affect (PBA), which is characterized by frequent, involuntary, and often sudden episodes of crying and/or laughing that are exaggerated and/or don’t match how you feel. PBA occurs secondary to a variety of otherwise unrelated neurologic conditions. Nuedexta® (dextromethorphan HBr and quinidine sulfate) was FDA-approved in 2011.