Biopharmaceutical company Cingulate has received a Complete Response Letter from the FDA for its New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl), a once-daily treatment for Attention Deficit/Hyperactivity Disorder. While the FDA identified specific Chemistry, Manufacturing and Controls (CMC) information requests, the agency raised no current concerns regarding the clinical safety or efficacy of the drug.
The response represents a narrowed set of requirements compared to what could have been a broader rejection. Cingulate CEO Shane J. Schaffer stated: “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.” The company expects to submit the requested information promptly and plans efficient resubmission to the FDA.
Financial Position and Timeline
Cingulate reported nearly $30 million in cash reserves, which it believes “provides sufficient capital to address the issues raised and execute on the resubmission process and continue pre-commercial activities into 2027.” The company submitted its NDA under the FDA’s 505(b)(2) pathway in October 2025, with an initial PDUFA target action date of May 31, 2026.
CTx-1301 Platform
CTx-1301 utilizes Cingulate’s proprietary Precision Timed Release (PTR) technology, a multi-core tablet that delivers three precisely timed releases of active medication across the day. The design aims to provide rapid onset of effect and all-day duration, addressing a key challenge in ADHD treatment.
ADHD Market Context
ADHD affects millions globally. The estimated U.S. ADHD market size is approximately 100 million annual prescriptions. In the United States, over 20 million patients have been diagnosed, including 12 million adults and over 8 million under age 17. According to the CDC, just 53.6% of all children and teens with ADHD reported active medication treatment in 2022, with 65–90% demonstrating clinical symptoms that persist into adulthood. Current market trends show adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/cingulate-receives-complete-response-letter-from-fda-for-ctx-1301