Pentixapharm Advances Phase 3 PANDA Study Preparations in the U.S.
Pentixapharm has received institutional review board approval for its pivotal Phase 3 PANDA study protocol. The company plans to begin patient enrollment in early 2027.
Berlin-based biotechnology company Pentixapharm Holding AG is moving forward with its Phase 3 PANDA study, aimed at evaluating [68Ga]Ga-PentixaFor for the non-invasive subtyping of primary aldosteronism. The company confirmed that the U.S. FDA raised no concerns regarding the study protocol submitted in August 2026, and a central institutional review board has since granted approval for the study documentation.
The trial is designed to enroll approximately 325 patients across more than ten selected U.S. academic medical centers and specialized adrenal clinics. Pentixapharm is currently finalizing agreements with these sites to facilitate the initiation of patient recruitment, which remains on schedule for the first quarter of 2027.
Primary aldosteronism is a common hormonal cause of hypertension that currently requires invasive catheter procedures for subtyping. Pentixapharm aims to replace these methods with its investigational radiopharmaceutical candidate. The company is set to discuss the study's progress and its financial results for the first nine months of 2026 during a webcast scheduled for November 12, 2026.