Molecular Insight Initiates Phase 2 Clinical Trial For Azedra

Molecular Insight has initiated a pivotal phase 2 clinical trial of Azedra for the treatment of malignant pheochromocytoma, a type of neuroendocrine cancer.

The single-arm trial will evaluate the efficacy and safety of Azedra in adult patients with malignant relapsed/refractory pheochromocytoma, and position Molecular Insight to file a New Drug Application (NDA).

The primary endpoint of the study will be Azedra’s ability to reduce the need for anti-hypertensive medications required to treat the elevated blood pressure, often seen as a key sign of the cancer. This trial has begun at centers in the US and ultimately will include sites in Western Europe.

Daniel Peters, president and CEO of Molecular Insight, said: The launch of this trial marks a significant milestone for our Azedra program, which addresses the clear need for new treatment options for pheochromocytoma. This targeted radiotherapeutic demonstrated high tumor uptake in preclinical studies and favorable pharmacokinetics in completed trials. Azedra’s development underscores Molecular Insight’s commitment to apply innovative approaches to address unmet patient needs.