Access to investigational medicines

Celcuity believes the best way for patients to access medicines prior to approval is through participation in clinical trials. To bring our new treatments to patients, we conduct clinical trials to assess the safety and efficacy of our investigational medicines. This information is submitted to regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada, to enable approval for patient use. We are currently conducting a clinical trial to assess the safety and efficacy of an investigational drug to be used as treatment for metastatic breast cancer.

Making our investigational therapy available through an Expanded Access Program is a complex matter that we have considered carefully. Providing early access to an investigational therapy can involve unknown risks, as well as an unfounded assumption of therapeutic benefit. Furthermore, an Expanded Access Program may make it harder to complete the studies necessary for the regulatory review and approval process that is ultimately the fastest path to making new therapies available to as many patients as possible.

Based on these considerations, Celcuity’s Expanded Access Program is only being offered to patients who initially received our investigational medicine as a participant in a clinical trial that is no longer open.  Participation in our Expanded Access Program will end once the investigational medicine is approved and becomes commercially available in the patient’s country.

We encourage patients to speak with their physicians about the possibility of enrolling in clinical trials to gain access to investigational therapies.

The PI3K – mTOR Pathway

How and why we target the PI3K and mTOR pathway in cancer


Internal development of a pan-PI3K/mTOR inhibitor