Updates on CTx-1301, NDA Resubmission After FDA Complete Response Letter

Drug developers Cingulate Inc anticipate resubmitting the New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) for attention-deficit/hyperactivity disorder (ADHD), in December 2026 or January 2027.¹ Chairman and chief executive officer Shane J. Schaffer, PharmD, shared the timeline while discussing the company’s progress in addressing the FDA’s Complete Response Letter.

The FDA accepted the CTx-1301 NDA for review in October 2025 and set a Prescription Drug User Fee Act target action date of May 31, 2026. The agency subsequently issued a Complete Response Letter (CRL) for the drug on June 1, 2026.² The letter requested specific information on chemistry, manufacturing, and controls (CMC) and did not raise concerns about the clinical safety or efficacy of the medication. The company said it is completing the requested CMC work and addressing the items outlined in the CRL, and it plans to resubmit the NDA as promptly as practicable. Cingulate cautioned that it cannot guarantee the timing of a resubmission or that the drug will be approved.

CTx-1301 is a once-daily, multi-core tablet that uses the company’s Precision Timed Release (PTR) platform to deliver 3 precisely timed releases of dexmethylphenidate across the day. The design aims to provide rapid onset of effect and coverage for the entire active day. The PTR platform uses a proprietary Erosion Barrier Layer that surrounds a drug-containing core in a tablet-in-tablet form. The layer is designed to erode at a controlled rate until the drug is released from the core, with no release before the intended time. CTx-1301 is being developed under the FDA’s 505(b)(2) pathway; CTx-1301 currently remains under development and has not been approved by the FDA.

Schaffer also provided insight into Cingulate’s commercialization preparations. He and Chief Commercial Officer Bryan Downey recently delivered presentations at the Indegene Digital Summit on evolving strategies for pharmaceutical commercialization and product launches.

References

1. Shane Schaffer, Cingulate chairman and CEO, provides update on CTx-1301 in interview with Innovators with Jane King. Press release. November 10, 2026. Accessed November 10, 2026. https://www.cingulate.com/news-releases/news-release-details/shane-schaffer-cingulate-chairman-and-ceo-provides-update-ctx

2. Walters J. FDA issues CRL for CTx-1301 for treatment of ADHD. Psychiatric Times. June 2, 2026. https://www.psychiatrictimes.com/view/fda-issues-crl-for-ctx-1301-for-treatment-of-adhd