Cingulate reports phase 3 safety data for CTx-1301 to treat ADHD in children, adolescentsLatest revision | Image Credit: © Stepan Popov - © Stepan Popov - stock.adobe.com.

Cingulate Inc. (NASDAQ: CING) has released Phase 3 safety data for CTx-1301 (dexmethylphenidate), a once-daily stimulant medication designed to provide full-day efficacy for individuals with Attention Deficit Hyperactivity Disorder (ADHD).^1,2

The data, which includes results from 2 pediatric and adolescent studies, will support the company’s New Drug Application (NDA) submission to the FDA, expected to be filed with the federal agency in the first half of 2025, according to news releases from Cingulate.

Key findings from the phase 3 safety analysis

According to study findings, no participants experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death, and there were no clinically relevant trends in TEAEs overall, stated Cingulate.¹

"While we have many approved stimulant medications at our disposal as clinicians, booster doses in the morning and/or afternoon are still needed, and these may lead to issues with adherence, efficacy, side effects such as crash and rebound, as well as the potential for abuse and diversion of these short-acting stimulant medications," stated Ann C. Childress, MD, in the news release.

Childress is a practicing psychiatrist and recent president of the American Professional Society of ADHD and Related Disorders.

"Having first-hand experience with Cingulate’s CTx-1301 product, I am excited for both patients and providers to have this treatment option [if] approved by the FDA to overcome the longstanding unmet needs facing our patients with ADHD," said Childress.

Overview of phase 3 pediatric trials

The CTx-1301 study, a dose-optimized, randomized, double-blind, placebo-controlled study, assessed the efficacy and safety of CTx-1301 in children ages 6-12 with ADHD.

Participants underwent an 8-week dose-optimization phase before being randomized to their optimal dose or placebo. The study lasted approximately 15 hours in a controlled laboratory setting, with a safety follow-up visit within 7 days.

In the CTx-1301-005 study, a double-blind, randomized, placebo-controlled, multi-center study, efficacy and safety of CTx-1301 in pediatric patients aged 6-17 years was evaluated.

The primary endpoint was the mean change in ADHD Rating Scale 5 (ADHD-RS-5) scores from baseline to Visit 8, with secondary endpoints assessing Clinical Global Impression - Severity (CGI-S) scores and multiple safety and pharmacokinetic analyses.

Addressing unmet needs in ADHD treatment

ADHD, a chronic neurobiological disorder, impacts approximately 6.4 million children and adolescents in the United States, according to Cingulate.

Symptoms often continue into adulthood. Current stimulant medications require multiple doses throughout the day, potentially causing issues with adherence and increased potential for side effects.

CTx-1301 aims to address challenges by delivering 3 precisely timed doses in a single tablet, ensuring consistent efficacy throughout the entire active day.

Cingulate plans to meet with the FDA on April 2, 2025, for a pre-NDA meeting, with a full NDA submission expected in the summer. If approved, CTx-1301 would become the first once-daily stimulant designed to provide full-day ADHD symptom control without the need for booster doses.

"The safety data from these three studies has been reviewed thoroughly, and we are pleased that the safety profile of CTx-1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials," said Shane J. Schaffer, CEO, Cingulate, in the company's announcement.

"As we look to bring to the market the first, true, once-daily stimulant medication that treats ADHD over the entire active day, we look forward to our in-person meeting with the FDA next month in preparation for the submission of our new drug application this summer," said Schaffer.

References:

1. Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025. Cingulate Inc. Press release. March 4, 2025. Accessed March 4, 2025. https://www.cingulate.com/news-releases/news-release-details/cingulate-reports-safety-results-final-phase-3-trials-lead-adhd

2. FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD. Cingulate Inc. Press release. May 21, 2024. Accessed March 4, 2025. https://www.cingulate.com/news-releases/news-release-details/fda-clears-cingulate-file-marketing-approval-ctx-1301-treatment