Expanded Access Policy
Last updated: September 22, 2026BioAge Labs, Inc. (“BioAge”) is a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging. For information regarding BioAge clinical trials, please visit https://clinicaltrials.gov (search: BioAge Labs).
Consistent with BioAge’s mission to bring innovative medicines to patients, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. However, we recognize that there are patients that may not be eligible for clinical trials or have access to alternative therapies.
Expanded access, also referred to as compassionate use, is a potential pathway that allows patients with serious or immediately life-threatening diseases or conditions to gain access to an investigational product outside of a clinical trial, when no comparable or satisfactory alternative therapy is available.
BioAge will evaluate requests for expanded access on a case-by-case basis and in a fair and equitable manner. Every request will receive careful consideration; however, BioAge cannot guarantee that any individual request will be granted or that access to investigational product will be provided through this policy.
Requests for expanded access will generally be considered based on the following criteria:
- The patient has a serious or immediately life-threatening disease or condition.
- The patient is not eligible for, or is otherwise unable to participate in, any clinical trial of the investigational product.
- There is no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the patient’s disease or condition, or the patient has exhausted all comparable and alternative therapies.
- There is sufficient evidence to suggest that the patient may benefit from the investigational product and that the potential benefit outweighs the known or anticipated risks of the investigational product in the judgment of the patient’s treating physician.
- Providing the investigational product will not interfere with ongoing or planned clinical trials that could support development of the investigational product or otherwise compromise its potential development for the disease or condition.
- BioAge has adequate supply of the investigational product to fulfill the request without jeopardizing supply for ongoing and planned clinical trials.
Expanded access requests must be initiated by a licensed physician on behalf of a specific, identified patient. BioAge does not accept expanded access requests directly from patients or caregivers. BioAge may require additional information in order to fully assess each request.
If expanded access is granted, the treating physician who is properly licensed and qualified must:
- Agree in writing to comply with all applicable country-specific legal and regulatory requirements related to the provision of investigational products under expanded access.
- Obtain the necessary approvals from relevant regulatory authorities and ethics committees or institutional review boards.
- Ensure the informed consent of the patient is obtained in accordance with applicable laws and regulations.
- Monitor the patient appropriately and fulfill all safety reporting obligations.
Physicians interested in submitting a request should contact:
BioAge Expanded Access Program Email: expandedaccess@bioagelabs.com
BioAge will acknowledge receipt of a physician’s inquiry within 5 business days and aims to provide a substantive response — whether the request can be supported and, if so, next steps — within 30 business days of receiving a complete request. Response times may vary depending on the complexity of the request and the information provided.
BioAge reserves the right to modify this policy at any time and will post updates on this page.
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© Copyright 2020-2026. All Rights Reserved
