Alzamend Neuro Inc (NASDAQ: ALZN) has submitted an investigational new drug (IND) application to the FDA to initiate AL001-MDD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for adjunctive treatment of patients with major depressive disorder (MDD).
Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for treating Alzheimer’s, BD, MDD, and PTSD.
Lithium, although not FDA-approved for MDD augmentation, has been used off-label for years, the company said.
It’s the FDA’s first-approved mood stabilizer and remains ...