Riluzole

Riluzole was developed by the French company Rhône-Poulenc Rorer, which ran the first trials; in the EU the Rilutek licence is held by Sanofi Winthrop Industrie. Generic riluzole tablets have been sold by many companies since 2003. The liquid (Tiglutik, Italfarmaco) and the mouth-dissolving film (Exservan, Aquestive Therapeutics) are newer brand-name versions of the same drug.

Glutamate is a chemical messenger that nerve cells use to signal each other. Too much of it is thought to over-stimulate and injure motor neurons in ALS. Riluzole reduces the release of glutamate and blocks some sodium channels on nerve cells. Exactly why this extends survival is not fully understood.

The FDA approved Rilutek tablets on December 12, 1995, and the European Commission authorised Rilutek on June 10, 1996. The FDA later approved a thickened liquid (Tiglutik, 2018) and an oral film (Exservan, 2019) for people who have trouble swallowing tablets. The EU label says riluzole extends life or time to mechanical ventilation, but has no proven effect on motor function, lung function or muscle strength.

In the first trial (155 people), 74% on riluzole were alive after 12 months versus 58% on placebo, with a bigger effect in people whose ALS began in the throat and mouth (bulbar onset). A larger dose-ranging trial (959 people) also showed better tracheostomy-free survival at 100 mg a day. A trial in older people with advanced ALS (168 people) and a Japanese trial (195 people) found no clear benefit. The Cochrane review pooling the trials found riluzole probably extends median survival by about two to three months; it found a small effect on function but none on muscle strength.

This is the most favourable result reported. See all key studies for the full picture.

Riluzole is approved for adults with ALS in general, whether sporadic or familial. The usual dose is 50 mg twice a day, taken at least one hour before or two hours after a meal. Doctors check liver blood tests before and during treatment, because riluzole can raise liver enzymes. The EU label notes it has not been shown to work in late-stage ALS.

Riluzole is an approved prescription medicine, so there is no trial needed to get it; ask your neurologist. Generic tablets are made by several companies, while the liquid and film versions are brand-name only. In September 2026 the ALS Association reported a temporary US shortage of riluzole 50 mg tablets; the manufacturer expected supply to recover through October 2026, and people were advised to ask pharmacists about other suppliers rather than stop on their own.