Phase I Clinical Trial

Illuminare-1, a small molecule, myelin binding agent, is being developed as a surgical adjunct to improve the visualization and delineation of critical nerve structures intra-operatively in real time with the aim of avoiding serious, and potentially permanent, unintended nerve injury. The first-in human clinical trial was completed at Memorial Sloan Kettering Cancer Center, along with collaborators from Illuminare Biotechnologies.

The Phase 1 trial of Illuminare-1 was a dose-escalation study including 38 patients undergoing robot-assisted radical prostatectomy. The Phase 1 trial met the primary objective of demonstrating safety and also met secondary objectives including determination of the human pharmacokinetics of Illuminare-1 and selection of optimal dose based on observed nerve fluorescence to advance to Phase 2 in the clinic. Results of the Phase 1 trial were published on July 2025 in JAMA Surgery. The article was accompanied by an invited editorial commentary.

Expanded Access Policy

Illuminare Biotechnologies Expanded Access Policy can be found here (Click Here)