The U.S. pharmaceutical company Cingulate announced on the 2nd that the U.S. Food and Drug Administration (FDA) has declined to approve its investigational new drug CTx-1301 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Cingulate stated that the FDA has issued a Complete Response Letter (CRL). In the letter, the U.S. regulatory body requested the company to provide additional supplementary information regarding the drug's manufacturing and quality control. However, the letter did not raise any questions or concerns about the drug's safety or clinical efficacy.

It is understood that Attention Deficit Hyperactivity Disorder (ADHD) often begins in childhood and can persist into adulthood. Its primary clinical manifestations include persistent inattention, hyperactivity, and impulsive behavior. The unapproved CTx-1301 is a once-daily dexmethylphenidate tablet. This active ingredient is already widely used in several approved ADHD medications and is intended to improve patient focus while reducing impulsivity and restless behavior.