Expanded Access

IRulya will consider requests from licensed treating physicians for access to investigational products in development for patient treatment purposes on a case-by-case basis. To advance investigational therapies, clinical studies are conducted to assess a product candidate’s safety and efficacy. After this data is collected and evaluated, the company may plan to apply to the U.S. Food and Drug Administration (FDA) and/or other relevant regulatory agencies to obtain approval to commercially market the product. A company cannot provide patients with broad access to products until the FDA and other regulatory agencies grant approval.

IRulya is focused on enrolling and conducting the clinical trials necessary to gain regulatory approval to make our medicines available broadly to patients as quickly and safely as possible.  We are privileged to collaborate with clinical investigators and with patients who participate in studies to develop potentially new, safe, and effective therapies.  We believe this approach will serve patients who could be helped by the therapies we are developing.  Because the safety and efficacy of our investigational drugs have not been fully established, IRulya does not normally offer access to our investigational drugs outside of our clinical trials but rather encourages patients to discuss other disease management options with their physicians.

Treating physicians interested in potential access to investigational products may request more information by contacting IRulya via email at clinical@IRulya.com.  Please note that only requests submitted by treating physicians will be considered.  Receipt of a request will be acknowledged within 10 business days.

The following criteria will be considered, including but not necessarily limited to:
Whether the patient is ineligible or unable to participate in an ongoing clinical trial;
Whether the patient has a serious or life-threatening disease or condition;
Whether there are comparable or alternative therapies available that would be satisfactory;
Whether the investigational therapy is currently being studied in humans;
Whether providing the investigational therapy on an expanded access basis will interfere with the conduct of clinical trials or any regulatory submissions;
Whether there are sufficient data to show that the potential benefits of the therapy outweigh the possible risks, based on available safety and efficacy data;
Whether IRulya plans to pursue regulatory approval for the therapy in the patient’s country; and/or
Whether there is an adequate supply of the investigational therapy.

The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting.

Because the circumstances of each request are different, there is no guarantee that expanded access will be granted for any of our investigational therapies. Additionally, IRulya reserves the right to deny any request at its discretion. IRulya’s decision on whether or not to grant expanded access to the investigational product under an Expanded Access Program should be communicated to the requestor within 15 business days of receipt.

You will find information about IRulya’s investigational therapies at www.irulya.com under Clinical Trials. If you have questions, please contact us at clinical@IRulya.com.

Please note: This policy is subject to change at the discretion of IRulya Therapeutics Inc. and subsequently, this web page will be updated to reflect any revisions to the policy.