Business Wire·Oct 3, 2025, 7:34 AM ET

Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for the Treatment of Cognitive Impairment Associated with Schizophrenia

The U.S. FDA granted Fast Track designation to Alto Neuroscience's ALTO-101 for treating cognitive impairment associated with schizophrenia (CIAS).
ALTO-101 is a novel small molecule phosphodiesterase-4 (PDE4) inhibitor that increases cAMP levels to enhance neural circuits & cognitive function.
Phase 1 data demonstrated significant pro-cognitive effects & clinically relevant changes in EEG measures in healthy volunteers.
Enrollment remains ongoing in a Phase 2 proof-of-concept study of ALTO-101 in patients with CIAS.
There are currently no approved treatments for CIAS, a core feature of schizophrenia that severely impacts daily functioning & quality of life.
Fast Track designation may enable more frequent FDA meetings, accelerated approval, & priority review if relevant criteria are met.
Alto's Precision Psychiatry Platform utilizes EEG activity, neurocognitive assessments, & wearable data to identify patients likely to respond to its candidates.