FDA Accepts NDA for CTx-1301 for Treatment of ADHD

The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dexmethylphenidate (CTx-1301), Cingulate’s lead candidate for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.¹

CTx-1301 is a once-daily, multi-core tablet that utilizes Cingulate’s proprietary Precision Timed Release platform to deliver 3 precisely timed releases of active medication across the day, a design that aims to provide rapid onset of effect and entire active-day duration. This NDA acceptance marks a major regulatory achievement for Cingulate and the CTx-1301 program. CTx-1301 is currently being reviewed via the FDA 505(b)(2) regulatory pathway, a path that allows sponsors to reference existing data on previously approved active ingredients while demonstrating novel clinical benefit through a differentiated delivery mechanism. Additionally, Cingulate received a fiscal year 2025 PDUFA fee waiver from the FDA—granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act—for this NDA, saving the company approximately $4.3 million.² 

“The acceptance of our NDA reflects the FDA’s recognition of the completeness of our submission and the strong body of evidence supporting CTx-1301’s efficacy, safety, and patient-centric design,” said Matt Brams, MD, Chief Medical Officer of Cingulate. “Our adult and pediatric studies consistently demonstrated rapid symptom relief, sustained performance and the flexibility of dosing with or without food—attributes that we believe will resonate strongly with both physicians and patients.”

The NDA submission follows completion of adult and pediatric phase 3 trials, completion of all FDA-requested studies, and a positive pre-NDA meeting in April 2025 confirming adequacy of the clinical and Chemistry, Manufacturing, and Controls data packages for review. In phase 3 clinical trials, CTx-1301 improved ADHD symptoms across multiple metrics in adult and pediatric patients aged 6 years and older. Effect size measurements were large throughout the day, demonstrating that CTx-1301 provides a rapid onset of effect and sustained efficacy into the afternoon and evening; this could address long-standing gaps in ADHD management. CTx-1301 also had a lower incidence of treatment-emergent adverse events (9%) compared with placebo (30%), indicating a favorable safety profile.³

“If approved, I believe CTx-1301 could potentially benefit the more than 60% of patients currently using immediate-release booster doses to extend the efficacy of their medications,” said Ann Childress, MD, the lead investigator of Cingulate’s CTx-1301 onset and duration study and president of the Center for Psychiatry and Behavior Medicine Inc.³

The FDA’s acceptance validates that Cingulate’s application meets the FDA’s standards for completeness and marks the beginning of the formal review period.

“FDA acceptance of our NDA marks a defining milestone for Cingulate,” said Jay Roberts, Cingulate’s executive chairman. “CTx-1301 was engineered to address the practical shortcomings of today’s stimulant therapies—multiple daily dosing, midday rebound, and adherence challenges—through a single, once-daily tablet. This milestone affirms the robustness of our clinical and regulatory strategy, and positions Cingulate to transition from a development-stage to a commercial-stage company in 2026, pending FDA approval of CTx-1301.”

References

1. FDA accepts Cingulate’s new drug application for CTx-1301 in attention-deficit/hyperactivity disorder (ADHD) and sets a May 31, 2026 PDUFA date. News release. October 14, 2025. Accessed October 14, 2025. https://finance.yahoo.com/news/fda-accepts-cingulate-drug-application-120000570.html

2. Kuntz L. Cingulate receives $4.3 million PDUFA fee waiver for ADHD treatment, CTx-1301. Psychiatric Times. July 29, 2025. https://www.psychiatrictimes.com/view/cingulate-receives-4-3-million-pdufa-fee-waiver-for-adhd-treatment-ctx-1301

3. Childress A, Brams M, Koehn K, et al. A phase 3, dose-optimized, double-blind, randomized, placebo controlled, single-center, parallel efficacy and safety laboratory classroom study in adults with attention-deficit/hyperactivity disorder (ADHD) using CTx-1301 (dexmethylphenidate): effect size assessment. American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting. Poster presentation. Accessed October 14, 2025. https://www.cingulate.com/static-files/b3c901ad-8d47-4ebc-b0a8-41c7330bc1b6