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June 9, 2026.— Pentixapharm Holding AG has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its lead CXCR4-targeted diagnostic program in treatment resistant hypertension with underlying Primary Aldosteronism.
With the IND now in effect, Pentixapharm is authorized to initiate its U.S.-focused, multi-center Phase 3 PANDA clinical study evaluating its novel imaging approach for patient stratification in hypertension, addressing a significant and underdiagnosed segment within endocrine/cardiovascular disease and representing a key near-term value driver for the company.
Phase 3 PANDA Study
The Phase 3 PANDA study has been designed based on prior interactions with the FDA, including formal feedback received in a Type B pre-IND meeting, which provided guidance on key statistical and methodological aspects as well as evidence requirements toward a potential approval pathway. The IND clearance confirms alignment with the FDA on the proposed study design and supports a registrational development strategy.
Pentixapharm's CXCR4-targeted imaging platform represents a first-in-class approach in cardiovascular diagnostics, enabling non-invasive assessment of disease biology and supporting more precise treatment decisions in hypertensive patients. The program addresses a major unmet need in a large and rapidly evolving cardiovascular market, with the potential to improve diagnostic pathways and enable more targeted therapeutic intervention.
"This IND clearance represents a key execution milestone and confirms our ability to deliver on our regulatory strategy," said Dirk Pleimes, Chief Executive Officer of Pentixapharm. "With our flagship PANDA program now advancing into Phase 3 in the United States, we are entering the next phase of value creation. Primary aldosteronism affects up to 10% of patients with hypertension, yet remains significantly underdiagnosed. We believe our first-in-class PET/CT imaging approach has the potential to transform how these patients are identified and, importantly, to guide treatment decisions by enabling precise subtype differentiation. We are focused on rapid study initiation and disciplined execution, while actively engaging with potential strategic partners across imaging and cardiovascular therapeutics. In parallel, we are advancing financing initiatives to support Phase 3 execution and our continued expansion in the U.S. market."
"The Phase 3 IND clearance is a critical milestone confirming that [⁶⁸Ga]Ga-PentixaFor has reached the technological maturity required for pivotal clinical execution," said Erik Merten, Chief Technology Officer of Pentixapharm. "We have established a robust and scalable manufacturing and supply infrastructure and are well positioned to ensure reliable supply as we initiate the Phase 3 program and progress toward potential commercialization."
May 28, 2026 
