FDA Declines Approval of Cingulate's ADHD Treatment Over Manufacturing Concerns

The FDA declined approval of Cingulate's CTx-1301, a once-daily dexmethylphenidate tablet for ADHD, on June 2, 2026, citing manufacturing-related concerns while flagging no safety or effectiveness issues. Cingulate plans to address the chemistry, manufacturing and controls requirements and resubmit promptly. The company has nearly $30 million in cash to support resubmission and operations into 2027. Novartis' Focalin XR uses the same active ingredient but with only two-stage release.

FDA rejection decision

• ▪The FDA cited manufacturing-related concerns as the reason for declining approval of Cingulate's CTx-1301
• ▪The FDA did not flag any concerns about CTx-1301's safety or effectiveness in its complete response letter to Cingulate
• ▪The U.S. Food and Drug Administration declined to approve Cingulate's CTx-1301 drug to treat attention deficit hyperactivity disorder on June 2, 2026

CTx-1301 drug profile

• ▪CTx-1301 aims to improve attention and curb impulsivity in patients with attention deficit hyperactivity disorder
• ▪Cingulate is aiming for CTx-1301 to address the midday wear-off seen with existing ADHD treatments and potentially improve adherence
• ▪Dexmethylphenidate belongs to a class of stimulant drugs that work by increasing the activity of dopamine and norepinephrine
• ▪CTx-1301 is a once-daily tablet form of dexmethylphenidate designed to treat attention deficit hyperactivity disorder

Manufacturing concerns

• ▪Cingulate CEO Shane Schaffer believes the outstanding FDA requests will be addressed quickly as Cingulate moves toward resubmission
• ▪Cingulate plans to promptly submit the requested information to the FDA following the complete response letter
• ▪Cingulate's immediate priority is to complete the chemistry, manufacturing and controls (CMC) requirements requested by the FDA

Financial runway through 2027

• ▪Cingulate has nearly $30 million in cash as of June 2, 2026
• ▪Cingulate expects its nearly $30 million in cash will support the resubmission process and operations into 2027

ADHD treatment market

• ▪Novartis' Focalin XR uses the same active ingredient as CTx-1301, dexmethylphenidate, but with only a two-stage release
• ▪Attention deficit hyperactivity disorder is a neurodevelopmental disorder that can cause persistent inattention, hyperactivity and impulsive behavior, often affecting children and continuing into adulthood
• ▪The ADHD treatment market includes Takeda Pharmaceutical's Vyvanse and Johnson & Johnson's Concerta