Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.

The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.

"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," said CEO Shane J. Schaffer.

Cingulate expects to promptly submit the requested information to address the issues raised by the FDA. The company reported having nearly $30 million in cash reserves, which it believes provides sufficient capital to address the FDA requests and execute the resubmission process.

The FDA had previously accepted Cingulate's New Drug Application for CTx-1301 in October 2025 and assigned a target action date of May 31, 2026, under the Prescription Drug User Fee Act. The drug is being evaluated under the FDA's 505(b)(2) pathway for ADHD treatment.

CTx-1301 utilizes Cingulate's proprietary drug delivery platform that incorporates an Erosion Barrier Layer technology licensed from BDD Pharma. The technology is designed to control drug release at precise, pre-defined times.