Clinical Expanded
Access Program
Xentria, Inc. (Xentria) is committed to developing therapies for patients with serious or life-threatening diseases, particularly where there are limited or no available treatment options. While participation in clinical trials is the preferred way for patients to access investigational products before regulatory approval, Xentria may, at its discretion, provide expanded access as continued access to investigational therapy for certain patients who have participated in qualifying XTMAB-16 clinical studies.
Who is Eligible
Xentria's Expanded Access Program is intended for patients who have completed a qualifying XTMAB-16 clinical study, and in the opinion of the treating physician, may benefit from continued access to investigational products outside of a clinical trial.
XTMAB-16 is being investigated as a treatment for pulmonary sarcoidosis. Information about Xentria's clinical program can be found at clinicaltrials.gov.
Expanded access under this program is limited to patients who meet the following criteria:
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy available.
- The patient does not qualify to participate in any ongoing clinical trials.
- The potential benefit of ongoing use of XTMAB-16 may outweigh the risks based on available safety data and the treating physician's clinical judgment.
- There is an appropriate regulatory pathway in the country or region to support expanded access in accordance with applicable local regulations.
How to Request Expanded Access
Treating physicians should submit requests in accordance with the applicable study or program procedures. If additional questions arise, treating physicians can reach out to [email protected]. Xentria cannot accept requests directly from patients or caregivers.
Evaluation Process
Requests are evaluated on a case-by-case basis through applicable, internal Xentria standard operating procedures.
Xentria will acknowledge receipt of expanded access inquiries within a reasonable period after receipt by the designated contact, subject to the completeness of the request and availability of necessary medical and regulatory information.
Additional Information
This program is not intended for patients who have not participated in a Xentria-sponsored clinical study of XTMAB-16.
Investigational products have not yet received regulatory approval; therefore, their potential risks and benefits are not fully established. Physicians and patients should consider all possible potential benefits and risks when seeking expanded access to an investigational product.
Expanded access is not intended to replace participation in clinical trials and is not guaranteed. Availability may change based on scientific, regulatory, supply, manufacturing, or business considerations.
Xentria, Inc. may revise this information at any time.
Last updated: June 2026