Actuate Therapeutics Receives FDA Approval for Oral Elraglusib Clinical Trial
Actuate Therapeutics announced the FDA has cleared its investigational new drug application to conduct a Phase 1/2 study of oral elraglusib in advanced cancer patients. The study is designed to demonstrate that a higher overall exposure to elraglusib can be achieved with the oral formulation compared to the IV formulation and will evaluate the safety and potential efficacy of the oral formulation as a monotherapy in solid tumor patients, including those with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers. "Advancing the elraglusib oral tablet is an important element to the success of our overall development strategy," said Daniel Schmitt, president and CEO of Actuate. Initiation of the clinical development is planned for the second half of 2026.
