Multiple clinical studies have been conducted providing important understanding about pridopidine’s safety, mechanism of action, and efficacy.
Activation of the S1R by pridopidine enhances the clearance of toxic proteins, enhances energy production, and reduces cellular stress and inflammation.
These mechanisms are crucial for a neuron’s function and survival.
Studies in animal models and human cells show that pridopidine prevents neuronal cell death, and strengthens and enhances the connections between neurons.
Pridopidine has an extensive safety and tolerability profile and was already evaluated in >1300 people including long term evaluation for >5 years.
Prilenia holds Orphan Drug Designation for pridopidine in both Huntington’s Disease (HD) and ALS in the U.S. and Europe. In addition, pridopidine recently received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of HD. Drugs that receive Fast Track designation may be eligible for more frequent communications with the FDA and may also qualify for accelerated approval and priority review of new drug applications.