EA Policies for Single Patient

Cigarette smoking remains one of the most pressing public health challenges in the US. Flik Therapeutics is a healthcare company that is dedicated to developing new therapies to help people quit smoking. Our lead investigational product, FLK-001, is a novel therapy under evaluation by the U.S. Food and Drug Administration (FDA). Our focus is on completing the rigorous clinical trials required by the FDA and other global health authorities so that this therapy may become widely available to patients seeking to quit smoking.

At this time, FLK-001 is not available through an Expanded Access program. Participation in our clinical trials remains the only way for patients to access this investigational therapy. These studies are carefully designed to evaluate safety, tolerability, and effectiveness, and we remain committed to generating the evidence necessary to support regulatory approval. More information about ongoing and future trials with FLK-001, including enrollment criteria, can be found at https://clinicaltrials.gov.