Cingulate Inc. (NASDAQ: CING) announced on November 10, 2026, that Chairman and CEO Shane J. Schaffer provided an update on the regulatory status of its lead asset, CTx-1301, during an interview on the program Innovators with Jane King. The company disclosed that it is working to address a Complete Response Letter (CRL) issued by the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for CTx-1301.
The FDA issued the CRL on June 1, 2026. The agency identified specific requests for additional chemistry, manufacturing, and controls (CMC) information but stated that the letter did not raise concerns regarding the clinical safety or efficacy of the drug. Cingulate has substantially completed the manufacturing work required to address these CMC requests with its contract drug manufacturing organization. The company is currently finalizing the supporting data and documentation for a resubmission of the NDA.
Management anticipates submitting the resubmission between December 2026 and January 2027. Upon receipt of a resubmission, the FDA is expected to classify it as either a Class 1 or a Class 2 resubmission, which carries review goals of two months and six months, respectively. If approved, the company currently expects that the commercial launch of CTx-1301 could commence in the third quarter of 2027. However, the company notes there can be no assurance regarding the timing or occurrence of a commercial launch, the resubmission timeline, or the ultimate approval of the NDA.
CTx-1301 is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release (PTR) platform to deliver dexmethylphenidate HCl. The drug is being evaluated for the treatment of attention deficit/hyperactivity disorder (ADHD) under the FDA’s 505(b)(2) pathway.
