FDA Clears Cingulate to File NDA for CTx-1301 in the Treatment of ADHD


The company has announced plans to submit the NDA in the first half of 2025.

paul craft_AdobeStock

paul craft_AdobeStock

Cingulate Inc has announced alignment with the US Food and Drug Administration (FDA) on the requirements for filing a New Drug Application (NDA) for its lead candidate, CTx-1301 (dexmethylphenidate). This medication is intended for the treatment of attention-deficit /hyperactivity disorder (ADHD) in patients aged 6 years and older.1

“We are pleased with the FDA’s guidance and perspective regarding our pathway to a timely NDA filing, and we will proceed to complete all remaining requirements accordingly,” said Shane J. Schaffer, Cingulate chairman and CEO, in a press release. “We also believe this communication provides additional go-to-market momentum as we continue to meet with potential partners for the outlicensing of CTx-1301 in the United States and abroad. Now that we have a clear path to submission, we look forward to engaging with key payer stakeholders to achieve maximum access and market penetration to benefit ADHD patients and their families.”

According to the FDA’s communication, the NDA for CTx-1301 can be submitted via the 505(b)(2) pathway, which simplifies the process by not requiring the continuation of a fixed dose study and an onset and duration study. Data already gathered from 2 phase 3 studies will be included in the NDA. Cingulate will also conduct a phase 1 fed/fast study, expected to last 2 to 3 weeks, and include its results in the filing.1

Cingulate shared additional insights into the results of its phase 3 study of CTx-1301 in a poster2 at the American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting in January 2024. The phase 3 study evaluated the safety and efficacy of CTx-1301 in adults with ADHD in a laboratory classroom setting, focusing on onset and duration of effect.2

Results showed that, among 26 enrolled patients, those on CTx-1301 showed an average improvement in Permanent Product Measure of Performance (PERMP) scores with an effect size ranging from 0.88 to 2.6, averaging 1.79, compared with placebo. CTx-1301 demonstrated an effect size of 1.41 at 30 minutes and 0.98 at 16 hours. CTx-1301 also had a lower incidence of treatment-emergent adverse events (9%) compared with placebo (30%), indicating a favorable safety profile.2

The investigators concluded that, “Although this study was not powered for statistical significance, there was clinically meaningful improvement of PERMP scores in [participants] who were randomized toCTx-1301, an improvement in the severity of illness, and a favorable safety profile compared to placebo.”2

According to Ann Childress, MD, lead investigator of Cingulate’s CTx-1301 onset and duration study and president of the Center for Psychiatry and Behavior Medicine Inc, “The treatment effect size of CTx-1301 was remarkable given the current effect sizes observed in the marketplace. Many patients require longer duration of efficacy and must add a second, or booster, dose to ensure treatment effect over their entire active day. The patients I observed, once notified they were taking CTx-1301, have expressed a desire to remain on the medication after the trial concluded. If approved, I believe CTx-1301 could potentially benefit the more than 60% of patients currently using immediate-release booster doses to extend the efficacy of their medications.”

Cingulate has announced that it has initiated the preparation of the NDA for CTx-1301 and plans to submit it in the first half of 2025.1

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of attention-deficit/hyperactivity disorder, and a wide variety of other psychiatric disorders at psychiatrictimes.com.

Note: This article was prepared with the assistance of ChatGPT.


1. FDA clears Cingulate to file for marketing approval of CTx-1301 in the treatment of ADHD. Cingulate Inc. News release. May 21, 2024. Accessed May 21, 2024. https://www.cingulate.com/news-releases/news-release-details/fda-clears-cingulate-file-marketing-approval-ctx-1301-treatment

2. Childress A, Brams M, Koehn K, et al. A phase 3, dose-optimized, double-blind, randomized, placebo controlled, single-center, parallel efficacy and safety laboratory classroom study in adults with attention-deficit/hyperactivity disorder (ADHD) using CTx-1301 (dexmethylphenidate): effect size assessment. American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting. Poster presentation. Accessed May 21, 2024. https://www.cingulate.com/static-files/b3c901ad-8d47-4ebc-b0a8-41c7330bc1b6

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