GSK Reportedly Pulls Application For Drug Touted By Trump As Potential Treatment For Autism

• FDA approved leucovorin in the treatment of cerebral folate transport deficiency last month but not in autism.
• Leucovorin garnered attention in the latter half of 2025 after Donald Trump and his administration promoted it as an "exciting" and “promising” therapeutic for autism.
• According to research published in The Lancet, outpatient leucovorin prescriptions for children aged 5–17 years increased by 71% following the press briefing in September.

UK drugmaker GSK Plc (GSK) has withdrawn its application for the drug leucovorin calcium touted by President Trump as a potential treatment for autism.

GSK asked the U.S. Food and Drug Administration to pull its application for leucovorin calcium because it no longer markets the medicine, a filing on the FDA website shows.

The news was first reported by The Wall Street Journal.  

Leucovorin Approval And Claims

According to WSJ, GSK said in September that it would submit an application for the drug in the treatment of cerebral folate transport deficiency following a request from the FDA. The agency approved the drug for the condition last month, but not for autism. The company, however, hasn’t sold the drug since 1999, the report noted.  

A GSK spokesperson reportedly told the newspaper that the company never intended to sell the drug again. Meanwhile, a spokesperson for the U.S. Department of Health and Human Services told the paper that GSK’s decision has no bearing on generic versions of the drug for patients with cerebral folate deficiency.

Leucovorin garnered attention in the latter half of 2025 after Donald Trump and his administration promoted it as an "exciting" and “promising” therapeutic for autism. According to research published in The Lancet, outpatient leucovorin prescriptions for children aged 5–17 years increased by 71% following the press briefing in September where Trump made his claims with Robert F Kennedy Jr.

How Did Retail Traders React?

On Stocktwits, retail sentiment around GSK stock stayed within the ‘bearish’ territory, while message volume remained at ‘low’ levels.

GSK stock has gained 69% over the past 12 months. 

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