Cingulate announced that the US Food and Drug Administration issued a Complete Response Letter for the New Drug Application for CTx-1301, an investigational dexmethylphenidate hydrochloride treatment for attention-deficit/hyperactivity disorder.

According to Cingulate, the agency’s feedback focused on specific Chemistry, Manufacturing and Controls requests and did not identify current concerns related to the clinical safety or efficacy of CTx-1301. The company did not release the FDA letter.

“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, CEO of Cingulate, said in the announcement.

Cingulate said it expects to submit the requested information to the FDA and that related CMC work is already underway with its manufacturing partner.

CTx-1301 is designed as a once-daily, multi-core tablet intended to provide three timed releases of dexmethylphenidate throughout the day using the company’s Precision Timed Release platform. The product is being evaluated under the FDA’s 505(b)(2) pathway.

The FDA accepted the NDA for review in October 2025 and assigned a Prescription Drug User Fee Act target action date of May 31, 2026. NDA acceptance indicates that an application is sufficiently complete to permit substantive review; it does not imply approval or guarantee a specific outcome.

CTx-1301 remains investigational and is not approved by the FDA for ADHD.

Source: Cingulate