March 2023 – Cantex Pharmaceuticals and Baptist Health Miami Cancer Institute announced that the FDA has issued a “Study May Proceed” letter for the Miami Cancer Institute’s investigator initiated clinical trial to assess the safety and effectiveness of azeliragon combined with stereotactic radiosurgery in patients with brain metastases.
February 2023 – Cantex Pharmaceuticals announced the FDA issued a “Study May Proceed” letter for the Phase 2 clinical trial to assess the safety and therapeutic effect of azeliragon in patients with newly diagnosed unmethylated glioblastoma treated with standard of care radiation therapy.
January 2023 – Cantex Pharmaceuticals announced that the FDA has granted Orphan Drug Designation to Cantex’ azeliragon, a well-tolerated once-a-day pill, for the treatment of glioblastoma.