Expanded Access Policy
Last updated: 7/16/2025
Calixis Inc. ("Calixis," "we," "us," or "our") is a clinical-stage company developing investigational medicines that have not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. This policy describes our approach to expanded access — sometimes called "compassionate use" or "pre-approval access" — through which a patient may seek treatment with an investigational medicine outside of a clinical trial.
Our current position
The best way for patients to access our investigational medicines is by participating in a clinical trial, where treatment is delivered under careful oversight and generates the data needed to bring a medicine to all patients who might benefit. At our current stage of development, we are not yet able to offer expanded access outside of our clinical trials / evaluate expanded access requests on a case-by-case basis. This position may change as our programs advance, and we will update this policy accordingly.
How we evaluate requests
When we consider a request for expanded access, we generally take into account factors such as:
- The patient has a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy.
- The patient is unable to participate in one of our clinical trials.
- The potential benefit to the patient justifies the potential risks, based on available data.
- Providing the investigational medicine will not interfere with, or compromise the timely completion of, our clinical trials or the development that could make the medicine available to all patients.
- We have adequate supply of the investigational medicine and the request can be met in accordance with applicable law and regulatory requirements.
Meeting one or more of these factors does not guarantee that a request will be granted. Each request is considered individually, and a licensed physician must be willing to oversee the patient's treatment and to comply with applicable regulatory requirements.
How a physician can submit a request
Requests for expanded access should be initiated by the patient's treating, licensed physician. Physicians may contact us at info@calixisbio.com [or provide phone/mailing details] to request information about whether expanded access may be available for a particular investigational medicine.
Clinical trial information
Information about our ongoing and planned clinical trials, which are the primary route to access our investigational medicines, is available at ClinicalTrials.gov. Our Phase 2 study of THB335 in chronic spontaneous urticaria is registered under NCT07766499.
Revisions to this policy
Calixis may revise this Expanded Access Policy at any time. As required by law, posting this policy does not obligate Calixis to provide any particular investigational medicine to any particular patient, and Calixis may amend this policy at any time. The "Last updated" date above reflects the most recent revision.
Questions
For questions about this policy, contact us at info@calixisbio.com or by mail at Calixis, Inc., Attn: Medical Information, 300 Technology Square, 8th Floor, Cambridge, MA 02139, United States.