pridopidine

Key facts

Generic name

pridopidine

Brand name(s)

Not stated in the official study record.

Gene requirement

Not gene-specific / no known gene requirement

Genetic confirmation

Not required by this record

ALS population

Adults with ALS enrolled under the PREVAiLS / PL101-ALS301 study protocol

Category

Investigational treatment

Regulatory status

INVESTIGATIONAL

FDA approval date

Not stated in the official study record.

Approval pathway

Not stated

Country / availability

State-level / commercial availability not verified

Route(s)

Oral

Administration

Administration details depend on formulation and individual care plan.

What is it?

An oral investigational treatment being evaluated in the PREVAiLS Phase 3 ALS study.

Indication: Investigational treatment for ALS; not FDA-approved for ALS.

Who is it for?

Adults with ALS enrolled under the PREVAiLS / PL101-ALS301 study protocol

How does it work?

Mechanism: Investigational mechanism; the linked study record defines the protocol and endpoints.

Target: Not stated in the official study record.

How is it administered?

Oral

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

Available formulations

Not stated in the official study record.

What evidence supported approval?

The linked ClinicalTrials.gov record is the official study record for the PREVAiLS program.

What is known about benefit?

Whether pridopidine slows ALS progression is being studied and is not established.

Important safety information

Investigational risks, placebo assignment, and eligibility are determined by the study protocol.

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.

• Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS (NCT07322003)

Official Sources