FDA issues complete response letter for Cingulate's ADHD drug CTx-1301

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Go back to FDA issues complete response letter for Cingulate's ADHD drug CTx-1301

Cingulate Receives Complete Response Letter from FDA for CTx-1301

June 2, 2026 8:00 AM EDT

No Clinical Safety or Efficacy Concerns Currently Identified 
Agency Feedback Primarily Focused on CMC-Related Requests
Company Plans Prompt Response and Submission of Requested Information
Company is Well Capitalized with Nearly $30 Million Cash on Hand

KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release (PTR) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for its New Drug Application (NDA) for... More