FDA-Approved Drugs for Treating ALS

There are currently six drugs approved by the U.S. Food and Drug Administration (FDA) to treat ALS and its symptoms: Qalsody, Radicava, Rilutek, Tiglutik, Exservan and Nuedexta. Please consult your doctor or health care professional about which ones may be right for you. 

In addition, research is being conducted all over the world to develop more treatments and a cure for ALS. Learn more about clinical trials

Qalsody (tofersen)

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.

Radicava™ (edaravone) 

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 by 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 of riluzole, which has been on the market for ALS for more than 20 years, was developed for people with severe swallowing difficulties. The oral film is placed on top of the person’s tongue and dissolves, bypassing the need to swallow a pill or liquid.  


Approved by the FDA in 2011, Nuedexta® (dextromethorphan HBr and quinidine sulfate) is prescribed to help treat 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 the person truly feels. PBA occurs secondary to a variety of otherwise unrelated neurologic conditions.

RELYVRIO (AMX0035), which is a combination of sodium phenylbutyrate and taurursodiol, was approved by the FDA to treat ALS in 2022. However, this medication was voluntarily removed from the U.S. and Canadian markets based on topline results from the phase 3 PHOENIX trial. As of April 4, 2024, RELYVRIO is no longer available to new patients. People living with ALS who were already receiving the therapy in the U.S. and Canada, where it was called Albrioza, were given the option to continue taking this medication after consulting with a health care professional. 

UPDATE – APRIL 2024: Relyvrio was voluntarily withdrawn from the market by Amylyx following a phase 3 trial that failed to show it was effective. The ALS Association stands by its decision to push for early approval of Relyvrio given the promising phase 2 trial data and the safety of the treatment. At the time, we said that if it turns out to be ineffective, at worst, people living with ALS would have taken an ineffective therapy without risk of harm. If it was indeed effective, delaying access would have meant that people living with ALS would have lost two years of being able to take a life-extending therapy. In the interests of transparency and education, we are leaving this information up for future reference. People living with ALS need life-saving treatments and we are working as urgently as possible to advance the many more potential treatments in clinical trials.

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