Pentixapharm, a clinical-stage biotech developing novel radiopharmaceuticals, has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a CXCR4-targeted diagnostic programme in treatment resistant hypertension with underlying primary Aldosteronism.
With the IND now in effect, Pentixapharm is authorised to initiate its US-focused, multi-centre 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.
The phase 3 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 programme 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.
