US FDA declines to approve Cingulate's ADHD drug

Cingulate said on Tuesday that the U.S. Food and Drug Administration declined to approve its drug to treat attention deficit hyperactivity disorder.

The FDA issued a complete response letter seeking additional information related to manufacturing and controls, but did not flag any concerns about the drug's safety or effectiveness, Cingulate said.

The drug, CTx-1301, is designed to target ADHD, which can cause persistent inattention, hyperactivity and impulsive behavior, often affecting children and continuing into adulthood.

The once-daily tablet form of dexmethylphenidate, an ingredient used in several approved ADHD drugs, aims to improve attention and reduce impulsive and restless behavior in patients with ADHD.

(Reporting by Kunal Das and Siddhi Mahatole in Bengaluru; Editing by Vijay Kishore and Diti Pujara)

Copyright Reuters or USA Today Network via Reuters Connect

This story was originally published June 2, 2026 at 5:10 AM.