Cingulate Announces Final Phase 3 Safety Results for ADHD Drug CTx-1301

KANSAS CITY, Kan., March 04, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company based in Kansas City, has released Phase 3 safety data for its experimental drug CTx-1301, which is aimed at treating Attention Deficit Hyperactivity Disorder (ADHD). This information highlights the drug's safety profile as determined from two pediatric and adolescent studies and a food effect study with adults. Cingulate plans to present this data to the FDA in a scheduled Pre-NDA meeting on April 2, 2025.

CTx-1301 is a version of dexmethylphenidate, a stimulant already used to treat ADHD, designed using Cingulate's proprietary Precision Timed Release™ (PTR™) technology. The studies involved a fixed dose study, a dose optimization study, and a food effect study with a single 50mg dose, which is the highest dosage being tested by Cingulate. The results of these studies have been encouraging, and the company intends to compile a comprehensive analysis that includes both adult and pediatric data for the NDA submission.

Cingulate Chairman and CEO Shane J. Schaffer expressed satisfaction with the safety profile of CTx-1301, stating it has shown consistent results across nine clinical trials. The company is working towards introducing the first true once-daily stimulant medication that provides coverage for the entire active day, which could significantly improve treatment outcomes for patients with ADHD.

Dr. Ann C. Childress, an expert in ADHD and a lead investigator in Cingulate's Phase 3 trials, underscored the potential benefits of CTx-1301. According to Dr. Childress, while there are numerous stimulant medications available, many require additional doses throughout the day, which can lead to compliance issues, side effects, and even abuse. With firsthand experience in evaluating CTx-1301, she is hopeful that once approved, it will offer a new, effective treatment option for ADHD patients and help address existing gaps in therapy.

ADHD is a prevalent neurodevelopmental disorder that affects millions of children and often continues into adulthood. It is characterized by symptoms such as inattention, hyperactivity, and impulsivity, which can interfere with daily functioning. In the United States alone, around 6.4 million children and teenagers under the age of 18 have been diagnosed with ADHD, and about 80 percent of them receive treatment. Despite this, many continue to show symptoms into adulthood, where the prevalence is estimated at 11 million individuals, although only a small percentage receive treatment.

CTx-1301 is designed to provide a solution to the ongoing challenge of ensuring that ADHD medications cover the entire active day. The drug employs Cingulate's PTR technology to deliver medication in three timed releases throughout the day, ensuring rapid onset and sustained efficacy without the need for booster doses. This approach aims to enhance patient adherence and minimize the side effects associated with short-acting stimulant medications.

Cingulate's PTR platform technology represents an innovative approach to drug delivery, using an Erosion Barrier Layer (EBL) to control the timing of drug release. This technology is poised to transform treatment regimens by providing truly once-daily dosing, not only for ADHD but potentially for other conditions like anxiety disorders.

Cingulate Inc. is a biopharmaceutical company dedicated to developing next-generation pharmaceutical products with its PTR platform, focusing initially on ADHD but also exploring other therapeutic areas. By leveraging this technology, Cingulate aims to improve patient outcomes and reduce the burden of frequent dosing in commonly diagnosed conditions.