Cingulate Inc. held a Pre-NDA meeting with the FDA to discuss its new drug application for CTx-1301, a treatment for ADHD. CTx-1301 uses Cingulate’s Precision Timed Release™ (PTR™) platform to deliver dexmethylphenidate HCl throughout the day. The company anticipates submitting the NDA in mid-2025.
The potential approval of CTx-1301 could address a significant unmet need in the ADHD treatment landscape. Current stimulant medications, while effective, often struggle to maintain efficacy throughout the entire active day. This leaves many patients inadequately treated for a portion of the day, impacting their ability to function effectively. CTx-1301’s timed-release design aims to provide consistent symptom control, potentially improving treatment outcomes and quality of life for ADHD patients. This innovation could shift the treatment paradigm and address the current limitations of existing medications.
Phase 3 safety data released last month reaffirmed the consistent safety profile of CTx-1301 across nine clinical trials. A combined analysis of adult and pediatric safety and efficacy data will be included in the NDA submission. The company’s PTR™ technology uses an Erosion Barrier Layer for precise drug delivery, offering a potential advantage over other drug delivery methods.
The upcoming NDA submission represents a critical step for Cingulate. A successful FDA review and subsequent approval would mark the introduction of a potentially game-changing ADHD treatment. This would not only validate Cingulate’s PTR™ platform but also position the company for significant growth within the expanding adult and pediatric ADHD markets. Furthermore, this success could pave the way for the application of PTR™ technology to other therapeutic areas where timed drug release is beneficial.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
