October 3, 2025 — Leads & Copy — Alto Neuroscience, Inc. (NYSE: ANRO) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS). There are currently no approved treatments for CIAS, a core feature of schizophrenia that severely impacts daily functioning and quality of life for millions of patients.
Fast Track designation is an FDA process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation may be eligible for more frequent meetings with the FDA to discuss the drug’s development plan, as well as eligibility for accelerated approval and priority review, if relevant criteria are met.
According to Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience, receiving Fast Track designation from the FDA underscores the critical need for new, effective treatments for patients suffering from cognitive impairment associated with schizophrenia. Etkin also said that this designation is a significant milestone for the ALTO-101 program and that the company believes it is a testament to its potential as a novel treatment approach. Alto’s Phase 1 data demonstrated significant and clinically relevant effects of ALTO-101 on both EEG measures and cognitive performance in healthy subjects, providing strong validation for its mechanism. The company is committed to advancing this program expeditiously for the millions of patients who currently have no approved treatment options to address these debilitating cognitive deficits.
ALTO-101 is a novel small molecule phosphodiesterase-4 (PDE4) inhibitor. The PDE4 enzyme plays a key role in the brain by breaking down cyclic adenosine monophosphate (cAMP), a molecule crucial for neuronal signaling and synaptic plasticity, which are fundamental to learning and memory. By inhibiting PDE4, ALTO-101 increases cAMP levels, which is believed to enhance neural circuits and improve cognitive function. The cognitive deficits in schizophrenia, which include impaired attention, memory, and executive function, represent a substantial and underserved aspect of the illness.
Cognitive impairment is a core and disabling feature of schizophrenia, affecting areas such as memory, attention, processing speed, and executive function. These deficits are a primary determinant of poor functional outcomes for patients, impacting their ability to work, maintain social relationships, and live independently. Currently, there are no approved treatments for CIAS, representing a significant unmet medical need for the millions of people living with schizophrenia worldwide.
Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, treatment resistant depression (TRD), and schizophrenia, and other mental health conditions.
Contact:
Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience.
Source: Alto Neuroscience
