FDA issued a Complete Response Letter for Cingulate’s ADHD candidate CTx-1301, requesting additional manufacturing data but raising no new safety or efficacy concerns.
Regulatory Desk
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Cingulate’s New Drug Application (NDA) seeking approval of CTx-1301 (dexmethylphenidate HCl) for attention-deficit/hyperactivity disorder (ADHD).
A CRL indicates that the FDA cannot approve the NDA in its current form but outlines deficiencies that must be resolved before reconsideration. The agency requested additional Chemistry, Manufacturing and Controls (CMC) information but did not raise concerns regarding clinical safety or efficacy, signaling that review hurdles are limited to manufacturing and product quality.
FDA Review Highlights
CTx-1301 was accepted for FDA review in October 2025 under the 505(b)(2) pathway, with a Prescription Drug User Fee Act (PDUFA) target date of May 31, 2026. While the FDA did not disclose specific deficiencies, CMC requests typically involve process validation, product specifications, quality controls, or facility documentation. Cingulate said it is working with its manufacturing partner to address the requests and expects to submit the information promptly.
Precision Timed Release Platform
CTx-1301 uses Cingulate’s proprietary Precision Timed Release (PTR) technology, designed to deliver three programmed releases of dexmethylphenidate from a single daily dose. The system employs an Erosion Barrier Layer to control release intervals, replicating multiple doses within one tablet. The approach aims to provide rapid onset and sustained coverage across school, work, and evening hours. Unlike many extended-release stimulants that taper by late afternoon, PTR is intended to maintain therapeutic effect into evening activities. Cingulate is also evaluating PTR in other therapeutic areas where timed release could offer clinical advantages.
ADHD Market Context
ADHD is among the most prevalent neurodevelopmental disorders, affecting more than 20 million Americans, including 12 million adults and over 8 million children. The U.S. market generates about 100 million prescriptions annually, with adult diagnoses rising faster than pediatric cases. According to CDC data, only 53.6% of children and adolescents with ADHD were actively using medication in 2022, underscoring unmet need for therapies that provide consistent coverage with simplified dosing.
Company Response and Next Steps
Chief Executive Officer Shane J. Schaffer emphasized that the FDA’s feedback was limited to manufacturing requirements, reinforcing confidence in the clinical package. He said the company’s nearly $30 million cash reserves should support completion of the requested CMC work, NDA resubmission, and pre-commercial preparations through 2027.
The timing of FDA review will depend on the scope of resubmission: limited updates may trigger a Class 1 (two-month) cycle, while broader updates require a Class 2 (six-month) review. Although the CRL delays potential approval, successful resolution could return CTx-1301 to consideration as a once-daily treatment option for patients living with ADHD.
Reference
Cingulate Receives Complete Response Letter from FDA for CTx-1301 – Cingulate Inc