Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Charlie Blackie-Kelly | October 14, 2025 | News story | | Alto Neuroscience, FDA, schizophrenia
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) has received Fast Track designation from the US Food and Drug Administration (FDA).
There are currently no approved therapies for CIAS, which affects cognitive domains such as memory, attention, processing speed and executive function. The condition can substantially reduce patients’ quality of life, often impairing their ability to work or live independently.
“Receiving Fast Track designation from the FDA underscores the critical need for new, effective treatments for patients suffering from cognitive impairment associated with schizophrenia,” said Amit Etkin, founder and chief executive officer of Alto Neuroscience. “This designation is a significant milestone for the ALTO-101 programme and we believe it is a testament to its potential as a novel treatment approach.”
ALTO-101 is a novel, small-molecule phosphodiesterase-4 (PDE4) inhibitor designed to target enzymes involved in the breakdown of molecules associated with learning and memory. By modulating neural circuits, the therapy aims to enhance cognitive function.
Positive phase 1 results demonstrated that ALTO-101 produced a statistically significant and clinically meaningful improvement in CIAS patients. Enrolment is now underway in a phase 2 proof-of-concept trial to further evaluate its efficacy and safety.
Alto Neuroscience is a clinical-stage biopharmaceutical company working to redefine psychiatry by leveraging neurobiology to develop personalised and highly effective treatment options. 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.
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