riluzole

Key facts

Generic name

riluzole

Brand name(s)

Rilutek, Tiglutik, Exservan

Gene requirement

Not gene-specific / no known gene requirement

Genetic confirmation

Not required by this record

ALS population

ALS generally; not restricted to a particular ALS gene

Category

ALS disease-targeting treatment

Regulatory status

FDA APPROVED

FDA approval date

12-12-1995

Approval pathway

Traditional approval

Country / availability

United States

Route(s)

Oral tablet, Oral suspension, Oral film

Administration

Administration details depend on formulation and individual care plan.

What is it?

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

Indication: FDA records identify riluzole formulations as indicated for the treatment of patients with ALS.

Who is it for?

ALS generally; not restricted to a particular ALS gene

How does it work?

Mechanism: Not stated in the official study record.

Target: Not stated in the official study record.

How is it administered?

Oral tablet, Oral suspension, Oral film

The route and formulation should be reviewed with the treating clinician.

Available formulations

What evidence supported approval?

The original riluzole approval record supports the ALS indication and the labeled survival/time-to-tracheostomy statement.

What is known about benefit?

The FDA Rilutek record states that riluzole extends survival and/or time to tracheostomy. This does not predict the benefit for a particular person.

Important safety information

Riluzole products have important warnings and monitoring considerations. Review product-specific prescribing information with the treating clinician.

This page does not provide dosing, prescribing, or individualized medical advice.

Related research

Research opportunities are separate from treatment availability. Eligibility, recruitment, and study status must be confirmed in the Research record.

• No linked research record in the Research database.

Official Sources