FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301
Pre-NDA Meeting Outcome: Cingulate Inc. has received formal pre-New Drug Application (NDA) meeting minutes from the FDA, indicating alignment with their plans to submit an NDA for their ADHD treatment, CTx-1301, this summer.
CTx-1301 Overview: CTx-1301 utilizes Cingulate's Precision Timed Release™ technology to provide a once-daily stimulant medication for ADHD, designed to deliver multiple doses throughout the day for optimal efficacy.
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Cingulate's Top ADHD Candidate CTx-1301 Chosen for Podium Presentation at AACAP Annual Meeting
CTx-1301 Presentation: Cingulate Inc. announced that data from its ADHD candidate CTx-1301 will be presented at the AACAP Annual Meeting, highlighting its once-daily, extended-release formulation aimed at improving treatment for ADHD patients.
Expert Presentation: Dr. Ann Childress, a leading ADHD specialist, will present the Phase 3 trial results, emphasizing CTx-1301's efficacy and safety in pediatric subjects with ADHD.
Innovative Drug Delivery: CTx-1301 utilizes Cingulate's Precision Timed Release™ platform to provide three timed releases of medication throughout the day, addressing limitations of current stimulant therapies.
Company Overview: Cingulate Inc. is focused on developing next-generation pharmaceutical products to enhance patient outcomes, with CTx-1301 in late-stage development for ADHD and other candidates targeting anxiety and neuropsychiatric conditions.
Cingulate Forms Exclusive Manufacturing Alliance with Bend Bio Sciences for Upcoming ADHD Treatment Commercialization
Commercial Supply Agreement: Cingulate Inc. has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301, its lead ADHD treatment, ensuring exclusive manufacturing capabilities in the U.S. through 2028, pending FDA approval.
Innovative Drug Delivery: CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology to provide a novel, extended-release formulation of dexmethylphenidate, designed to improve ADHD treatment by delivering medication in a controlled manner throughout the day.