FDA Reapproves Leucovorin: A New Hope for Autism?

The FDA has reapproved leucovorin, a form of folate, which was previously withdrawn by GlaxoSmithKline. This drug is used in cancer treatment and specific anemias, and it shows potential for treating autism-related symptoms. However, evidence remains limited and more research is necessary.


Devdiscourse News Desk | Updated: 23-09-2025 02:21 IST | Created: 23-09-2025 02:21 IST
FDA Reapproves Leucovorin: A New Hope for Autism?
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The U.S. Food and Drug Administration has granted reapproval to a version of leucovorin produced by GlaxoSmithKline, following its previous withdrawal from consideration. This approval comes ahead of President Donald Trump's speech on Monday, marking a significant development for the drug used primarily to counter certain cancer drug effects.

Leucovorin, a form of folate, is crucial in treating various medical conditions, including specific anemias and neurological symptoms associated with autism. It assists in cell growth, division, and sustains a healthy immune system. Notably, adequate folate levels are vital for fetal development, as they prevent neural tube defects, according to health experts.

Though leucovorin is being used off-label to manage autism symptoms, the scientific community remains cautious. Existing studies, although suggestive, are based on small sample sizes and diverse doses, leaving experts like Dr. David Mandell skeptical of the drug's efficacy without further research.

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