UPDATE 1-US FDA declines to approve Cingulate's ADHD drug

Cingulate, Inc.

Cingulate, Inc.

CING

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Adds details from paragraph 2

- Cingulate CING.O 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.