Background
The tablet form of Riluzole, Rilutek, was approved by the Food and Drug Administration (FDA) in USA in 1995 and by the European Medicine Agency (EMA) in Europe in 1996. Tiglutik or Teglutik is an oral suspension formulation of Riluzole for people living with Amyotrophic Lateral Sclerosis (ALS) or Motor Neuron Disease (MND) that have difficulty swallowing tablets. Riluzole is currently approved in many countries including USA, Canada, Europe, Israel, Australia, Brazil, Japan and China. Furthermore, a thin film version of riluzole is available in the US (with the commercial name of Exservan), in UK and in the EU.
| Approved in: | Commercial Name: |
| USA | Riluzole / Rilutek® tablet |
| Tiglutik® oral suspension | |
| Exservan® orodispersible film | |
| Europe/EU | Riluzole / Rilutek® tablet |
| Teglutik® oral suspension | |
| Emylif® orodispersible film | |
| Canada | Riluzole / Rilutek® tablet |
| Tiglutik® oral suspension | |
| Israel | Riluzole / Rilutek® tablet |
| Teglutik® oral suspension | |
| Australia | Riluzole / Rilutek® tablet |
| Teglutik® oral suspension | |
| Brazil | Riluzole tablet |
| Japan | Riluzole / Rilutek® tablet |
| China | Riluzole tablet |
| UK | Riluzole / Rilutek® tablet |
| Teglutik® oral suspension | |
| Emylif® orodispersible film |
Proposed Mechanism of Action
Riluzole’s mechanism of action is not fully understood, however, it is thought to interfere with the excessive neurotransmitter (glutamate) release that leads to excitotoxicity in ALS/MND causing a dysregulated neuronal activation. This may lead to neuronal damage and eventually death (Van den Bosch, 2006). Of note, other clinical trials in people living with ALS/MND with compounds that have a similar mechanism of action have failed. Therefore, Riluzole’s action has been hypothesized to expand to other aspects of neurotransmission or even other molecular mechanisms linked to ALS. These hypotheses are currently under investigation.
Clinical Trials
Riluzole was approved based on two international clinical trials that included a total of 1114 people living with ALS/MND (PALS).
In the first study, published in 1994, 155 PALS were treated with 100mg of Riluzole or placebo daily for 12 months. By the end of the study, the treatment extended survival or time until tracheostomy (where a breathing tube is inserted directly into the throat) by roughly three months compared to placebo.
In the second study, published in 1996, 959 PALS were treated with three different concentrations of Riluzole (50, 100, 200mg) or placebo daily for 18 months. Both the 100 and 200mg treated groups showed significant delay in the need for tracheostomy or extended survival when compared to placebo. However, the 200mg dose resulted in more side effects.
Dose and Administration
Riluzole has several brand names, and it comes in three forms:
- Rilutek tablets contain 50mg of active compound (Riluzole). The recommended dose is 50mg twice daily (every 12 hours) taken orally.
- Tiglutik or Teglutik is recommended for patients who have difficulty in swallowing or receive nutrition via feeding tube. The dosage recommendation is the same as Rilutek. The FDA approved Tiglutik, in 2018 whereas Teglutik, has been available in the UK since 2015.
- Exservan comes in a thin film that dissolves on the tongue. Exservan is applied one to two hours prior to a meal.
Riluzole is recommended for all patients diagnosed with ALS, however due to lack of studies, it is unclear whether it is equally effective after five years from symptom onset.
Reported Side Effects
Riluzole is safe and generally well tolerated at a dose of 100mg daily for up to seven years. The most common side effects are numbness around the mouth, nausea, dizziness, diarrhea, lack of energy, high blood pressure, decreased lung function and abdominal pain. Additionally, rare cases have reported liver injury. Riluzole should be administered and monitored under the care of a physician.
Current Status
In 2020, a study showed that out 15 peer-reviewed studies in PALS treated with riluzole in real-world settings, eight found that survival was a median of 6 to 19 months longer on riluzole than on placebo. Another real world study undertaken in 2025 on the European-based PRECISION-ALS database showed a 7-month median survival benefit with the greatest benefit seen in fast-progressing patients
Riluzole’s effects and safety continue to be investigated in people living with ALS/MND.
International Alliance of ALS/MND Associations
April 2026
Disclaimer: Consult with your doctor to determine if riluzole/Tiglutik is an option for you. Always disclose your medical history, including any drugs, natural supplements, or herbal medicines you are currently using. Your doctor will determine the right plan for your needs.
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