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Fasoracetam () is an experimental drug of the racetam group which was never marketed. It is a putative nootropic that failed to show sufficient efficacy in for vascular dementia. The drug was also subsequently drug repurposing for treatment of a variety of other conditions, such as attention deficit hyperactivity disorder (ADHD), but effectiveness for ADHD was disappointing and development of fasoracetam for most other conditions has been discontinued as well. In any case, it remains under development for treatment of DiGeorge syndrome.
Scientists at Children's Hospital of Philadelphia led by Hakon Hakonarson have studied fasoracetam's potential use in attention deficit hyperactivity disorder. Hakonarson's company neuroFix tried to bring the drug to market for this use; neuroFix acquired Nippon Shinyaku's clinical data as part of its efforts. neuroFix was acquired by Medgenics in 2015. Medgenics changed its name to Aevi Genomic Medicine in 2016.
Clinical trials in adolescents with ADHD who also have mGluR mutations started in 2016. While fasoracetam may be effective in the treatment of ADHD in people with specific mGluR mutations, these represent around 10% of total ADHD cases, and fasoracetam is likely ineffective in all other cases. Studies showing improvements in cognitive function from fasoracetam have exclusively been done on rodents.
Fasoracetam (developmental code names AFEVI-001, LAM-105, MDGN-001, NFC-1, NS-105) was under development by Avalo Therapeutics (previously Cerecor) for the treatment of attention deficit hyperactivity disorder (ADHD), autistic disorder, cognition disorders, DiGeorge syndrome, and major depressive disorder. However, development for all indications was discontinued by 2018. The drug (developmental code name NB-001) is also under development by Nobias Therapeutics for the treatment of DiGeorge syndrome and is in phase 2 for this use as of October 2023. A cocrystal form of fasoracetam (developmental code name AEVI-004) is under development by Avalo Therapeutics for the treatment of ADHD, autistic disorder, and epilepsy as well. However, no recent development has been reported for these indications as of April 2023.
The results of clinical studies for ADHD with fasoracetam have not shown statistical significance in efficacy.
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