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Cingulate plans NDA resubmission for ADHD drug CTx-1301 between December 2026 and January 2027
CINGCingulate Inc.
Cingulate Inc. announced that it is finalizing data to address an FDA Complete Response Letter regarding the New Drug Application (NDA) for its lead asset, CTx-1301, a once-daily tablet for ADHD. The company expects to resubmit the NDA between December 2026 and January 2027 after completing requested chemistry, manufacturing, and controls work. Subject to FDA approval, commercial launch is anticipated in the third quarter of 2027. Cingulate Inc. is a biopharmaceutical company utilizing its proprietary Precision Timed Release platform to develop next-generation pharmaceutical products.