FDA Issues Complete Response Letter for Cingulate ADHD Drug CTx-1301

The US Food and Drug Administration has issued a Complete Response Letter to Cingulate for its New Drug Application for CTx-1301, an investigational once-daily dexmethylphenidate HCl tablet for the treatment of attention-deficit/hyperactivity disorder.

According to Cingulate, the FDA’s response identified specific chemistry, manufacturing, and controls information requests and did not identify any current concerns related to the clinical safety or efficacy of CTx-1301. The company stated that it expects to submit the requested information promptly.

“We are encouraged that the FDA’s response was limited to specific information requests related to CMC and did not currently identify any issues related to the clinical safety or efficacy of CTx-1301,” Shane J. Schaffer, chairman and CEO of Cingulate, said in the company announcement. “Our immediate priority is to complete the CMC work already underway with our manufacturing partner; we believe the outstanding requests will be addressed quickly as we move efficiently toward resubmission.”

CTx-1301 is being evaluated under the FDA’s 505(b)(2) pathway for the treatment of ADHD. The investigational therapy uses Cingulate’s proprietary Precision Timed Release drug delivery platform, which is designed to provide 3 timed releases of active medication throughout the day. According to the company, the goal is to provide rapid onset and active-day symptom coverage with once-daily dosing.

The FDA accepted the New Drug Application for CTx-1301 in October 2025 and assigned a Prescription Drug User Fee Act target action date of May 31, 2026. Acceptance of an application indicates that the FDA considered the submission complete enough for substantive review but does not indicate approval or guarantee a specific regulatory outcome.

ADHD is a chronic neurobiological and developmental disorder characterized by persistent symptoms of inattention and/or hyperactivity-impulsivity that interfere with functioning or development. Cingulate cited estimates that more than 20 million patients in the United States have been diagnosed with ADHD, including 12 million adults and more than 8 million children and adolescents younger than 17 years.

Cingulate stated that it had nearly $30 million in cash reserves, which the company believes is sufficient to address the FDA’s requests, pursue resubmission, and continue precommercial activities into 2027.

Reference

1. Cingulate Inc. Cingulate receives Complete Response Letter from FDA for CTx-1301. Published June 2, 2026. Accessed June 2, 2026. https://www.cingulate.com/news-releases/news-release-details/cingulate-receives-complete-response-letter-fda-ctx-1301