FDA approves drug that Trump due to suggest as autism treatment

September 22, 2025 4:55 PM EDT

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

(In Sept 22 story, corrects paragraph one to folinic acid from folic acid)

(Reuters) -The U.S. Food and Drug Administration announced approval of leucovorin, or folinic acid, that U.S. President Donald Trump was slated to suggest as a treatment for autism symptoms at a White House event on Monday.

The FDA published a notice in the Federal Register.

GSK previously manufactured leucovorin and sold it under the name Wellcovorin. The company withdrew the drug from the market, but not for reasons of safety or effectiveness.

The Federal Register notice cited "patient-level data on over 40 patients, including both adults and pediatric patients" to support the finding that the drug can improve symptoms from cerebral folate deficiency (CFD).

According to the Federal Register entry, CFD has been reported in patients with neuropsychiatric symptoms, including autistic features.

(Reporting by Michael Erman in New Jersey and Ryan Patrick Jones in Toronto; Editing by Caitlin Webber and Cynthia Osterman)



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