Cingulate's ADHD Drug CTx-1301 Hit by FDA Complete Response Letter

Cingulate Inc. (CING) announced on June 2, 2026, that the U.S. Food and Drug Administration issued a complete response letter for its attention-deficit/hyperactivity disorder treatment candidate CTx-1301, rejecting the application in its current form. The company’s shares fell sharply in pre-market trading. The FDA letter outlines deficiencies that must be resolved before the drug can gain approval, though Cingulate did not immediately disclose specific details. The company stated it plans to request a meeting with the agency to discuss the required next steps. CTx-1301 is a once-daily, multi-core formulation of dexmethylphenidate designed to provide rapid onset and extended coverage of ADHD symptoms. The rebuff marks a significant setback for Cingulate, which has no approved products on the market. The company said it will evaluate the FDA’s feedback to determine the pathway forward.