A total of 282 children participated in the various studies around the world on folinic acid and autism:
• USA (2018): 48 children
• France (2020): 19 children
• Iran (2021): 55 children
• India (2024): 80 children
• China (2025): 80 children
All the studies found improvements with the children who received folinic acid.
📊 Important Comparison: According to Dr. Richard Frye, the number of children studied on folinic acid (over 250) "is similar to the number of children who participated in the registration studies for FDA approval of currently approved autism medications" (such as Risperdal):
- Risperdal (Risperidone) received FDA approval in 2006 based on two 8-week studies that included 156 children, of whom 76 received treatment.
- Aripiprazole received FDA approval in 2009 following two 8-week studies that included 316 children, with 204 of them receiving treatment at varying doses.
- Leucovorin was studied in five controlled and blinded clinical trials, including about 280 children with ASD, with one of the studies lasting up to 24 weeks.
Additionally, the FDA is currently examining approval for Leucovorin for children and adults with cerebral folate deficiency (CFD), based on an analysis of data from about 40 cases that showed improvements in behavior and language.
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