Explainer-Why is leucovorin being considered as an autism treatment?


  • World
  • Tuesday, 23 Sep 2025

FILE PHOTO: Signage is pictured in the main lobby of GSK offices in London, Britain, February 20, 2025. REUTERS/Chris J. Ratcliffe/ File Photo

(Reuters) -On Monday, the U.S. Food and Drug Administration published a notice to the Federal Register ahead of a speech by President Donald Trump, approving a version of leucovorin made by GlaxoSmithKline that the company had previously withdrawn from the FDA's consideration when it stopped manufacturing the drug.

The FDA cited a review of the use of leucovorin in 40 patients with a rare metabolic disorder called cerebral folate deficiency that can lead to a range of neurological symptoms, some of which are seen in people with autism.

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