At Pentixapharm (PTP), we are committed to delivering breakthrough, diagnostic and therapeutic radiopharmaceuticals to improve and extend the lives of patients battling primary aldosteronism, hematologic malignancies and solid tumors. Our primary focus is to conduct the clinical trials necessary to obtain regulatory approvals and ensure timely, broad, and safe access to our investigational medicines.

FDA Expanded Access (also called Pre-approval access or Compassionate Use) is a potential pathway for patients with serious or life-threatening conditions to gain access to investigational products outside of a clinical trial, when no satisfactory alternative treatment options exist.

Our current position. PTP is a small clinical-stage company, and our investigational radiopharmaceuticals are still under study. At this stage of development, PTP does not provide Expanded Access programs in the United States outside of the clinical trials.

We believe that participation in a clinical trial is the most appropriate and reliable means of accessing our investigational radiopharmaceuticals. Information about PTP’s ongoing clinical trials can be found in the Pipeline section of PTP’s website or by visiting ClinicalTrials.gov.

If we reconsider in the future. PTP reviews this position regularly and may update it as our programs mature. Any future consideration of an expanded access request would be guided by whether:

• the patient has a serious or life-threatening condition, has no satisfactory alternative treatment, and is not eligible for an ongoing PTP trial;

• there is sufficient clinical safety and dosimetry data to support use outside a controlled trial setting;

• a qualified treating physician, at a facility equipped for the safe handling and administration of radiopharmaceuticals, is willing to assume the applicable regulatory responsibilities;

• adequate product supply is available without disrupting clinical trial enrollment or supply;

• the request can be met consistent with applicable US regulatory, import, and radiation-safety requirements; and

• providing access would not compromise the integrity or timely completion of our development programs.

Posting this policy does not guarantee access to any investigational product for any individual patient, and PTP may revise this policy at any time.

PTP focuses its resources on advancing its investigational products efficiently through clinical development.  To support academic research in the United States, PTP supports investigator initiated clinical studies (IIS). IIS requests are submitted via iis@pentixapharm.com. Proposed research must offer meaningful scientific objectives, be supported by a valid study design and fully safeguard the privacy, safety and welfare of patients and animals.

On July 6, 2026, the U.S. Food and Drug Administration granted Fast Track Designation to PentixaFor for the diagnostic subtyping of adults with confirmed diagnosis of primary aldosteronism (PA). While Fast Track Designation does not require the establishment of an Expanded Access program, PTP is publishing this policy in alignment with the transparency principles of the 21st Century Cures Act.

Contact. Questions about expanded access to PTP investigational products may be directed to expandedaccess@pentixapharm.com. We aim to acknowledge receipt within 10 business days. Acknowledgment of an inquiry is not a commitment to provide access.