Clexio Biosciences Ltd. (“Clexio”) is a clinical-stage pharmaceutical company, developing a rich portfolio of novel treatments, mostly focused on CNS and some additional indications, to improve patients’ lives. Clexio is committed to bringing innovative, safe and effective therapies to patients by conducting rigorous clinical trials and obtaining marketing approval by the FDA and other regulatory authorities.
Expanded access programs, also known as “pre-approval access” or “compassionate use”, are potential pathways for patients to receive investigational drugs that are not yet approved by the FDA or other regulatory authorities but may be beneficial for patients with serious or life-threatening conditions. Under these programs, patients who are unable to participate in a clinical trial may potentially receive the investigational drug outside of clinical trials.Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. The following is Clexio’s policy for evaluating and responding to requests for individual patient access to investigational drugs that are intended to treat serious diseases.
Clexio believes that investigational drugs should be studied in patients as part of clinical trials designated to obtain data on safety and efficacy, that may be used to support approval of the product and subsequent wider accessibility to patients. Therefore, participating in clinical trials is the first and most preferable route to receive investigational drugs. As such, at the present time, Clexio does not provide access to its investigational drugs outside of clinical trials.
Request Procedure
Clexio will only provide access to investigational drugs through participation in clinical trials. Thus, patients are encouraged to speak with their physicians and to participate in Clexio’s clinical trials registered on www.clinicaltrials.gov. A treating physician may submit questions or requests regarding Clexio’s expanded access policy or clinical trials to the following: clinicalops@clexio.com
Additional information may be obtained from the U.S. Food and Drug Administration at
https://www.fda.gov/downloads/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm504494.pdf
Anticipated Timing
Clexio will endeavor to acknowledge receipt of any expanded access question or request within 10 business days of receipt.
As authorized by the 21st Century Cures Act, Clexio may revise this expanded access policy at any time.
Last updated: March 2024