Pentixapharm can begin a U.S. multicenter phase 3 study of Ga-68 pentixafor PET/CT after FDA clearance of its investigational new drug application.
The PANDA study will evaluate the CXCR4-targeted radiodiagnostic in patients with treatment-resistant hypertension and underlying primary aldosteronism. Pentixapharm said the trial is designed to assess patient stratification and disease subtyping.
Ga-68 pentixafor is intended to visualize chemokine receptor CXCR4 expression with PET/CT. The company said CXCR4 is overexpressed in aldosterone-producing adrenal tumors, a feature associated with unilateral primary aldosteronism.
Subtype classification is the central clinical question. Unilateral disease is typically treated with surgical removal of the affected adrenal gland, while bilateral disease is usually managed with long-term medical therapy, according to Pentixapharm.
The company said the PANDA design follows prior FDA interactions, including Type B pre-IND feedback on statistical, methodological, and evidence requirements for a potential approval pathway.
Pentixapharm submitted the IND in May 2026. The company said clearance means the IND is now in effect and the U.S.-focused phase 3 program may proceed.
Earlier clinical work supports the development path. In January, the Journal of Nuclear Medicine published an Australian prospective cohort study evaluating Ga-68 pentixafor PET/CT as a noninvasive imaging alternative to adrenal vein sampling in adults with primary aldosteronism and adrenal adenoma visible on CT.
Pentixapharm said published and ongoing clinical experience with Ga-68 pentixafor PET/CT includes more than 2,600 patients across multiple indications, including more than 1,600 patients with primary aldosteronism.
The agent remains investigational in this indication. IND clearance permits clinical study activity but is not FDA approval for commercial use.
Company:Pentixapharm
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