Pursuing therapies targeting the PAM (PI3K/AKT/mTOR) pathway

The best way for eligible patients to access medicines prior to approval is through participation in clinical trials. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others.

In cases where a clinical trial isn’t an option, or following approval of a medicine in cases where commercial product is not yet available, health authorities may grant permission for Celcuity to provide a treating physician with access to an investigational drug. These programs are called “expanded access” or “compassionate use” but may go by other names. Celcuity refers to these requests as expanded access. Physician requests for participation in Celcuity’s expanded access program may be made by emailing: [email protected].

We encourage patients to speak first with their physician about their eligibility to enroll in a clinical trial or their need for an investigational medicine that has been approved but is supply constrained. If a treating physician believes expanded access may be the only option for a patient, the physician should contact Celcuity to make a formal request on behalf of the patient. This will enable the physician to work with Celcuity’s Medical team to determine the best course of action.

The request for access an investigational Celcuity product can only be considered if the patient’s treating physician is committed to, and supportive of, the requested treatment.