Cingulate Receives $4.3 Million PDUFA Fee Waiver for ADHD Treatment, CTx-1301

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Cingulate announced today that it has received a fiscal year 2025 Prescription Drug User Fee Act (PDUFA) fee waiver from the US Food and Drug Administration (FDA) for its new drug application (NDA) for dexmethylphenidate HCI (CTx-1301) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.¹

The waiver, granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act, will save Cingulate approximately $4.3 million as it prepares to submit its NDA at the end of this month.

“We are pleased to receive this significant waiver as we approach the submission of our NDA in the coming days and look forward to continuing to work with the FDA throughout the submission and review process,” said Shane J. Schaffer, chairman and CEO of Cingulate. “This waiver will save Cingulate more than $4 million and strengthen our financial position as we prepare to commercialize CTx-1301.”¹

CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate and Cingulate’s lead candidate. CTx-1301 utilizes Cingulate’s proprietary Precision Timed Release Platform Technology drug delivery to precisely deliver 3 releases of medication at the predefined time, ratio, and style in 1 tablet, optimizing patient care. Patients experience rapid onset and entire active-day efficacy, with the third dose of medication released around the time when other extended-release stimulant products begin to wear off.

In the phase 3 study evaluating the safety and efficacy of CTx-1301 in adults with ADHD in a laboratory classroom setting, 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

Ann Childress, MD, the lead investigator of Cingulate’s CTx-1301 onset and duration study and president of the Center for Psychiatry and Behavior Medicine Inc, shared that, “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.”²

While stimulants are considered first-line options for ADHD treatment, they come with the long-standing challenge of providing patients with an entire active-day duration of action.

“We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and that offers eight dose strengths so that medical professionals can effectively optimize a patient’s medication,” said Schaffer.³

References

1. Cingulate receives $4.3m waiver from FDA ahead of imminent filing for marketing approval of lead ADHD asset CTx-1301. News release. July 29, 2025. https://www.cingulate.com/news-releases/news-release-details/cingulate-receives-43m-waiver-fda-ahead-imminent-filing

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

3. Cingulate announces positive top-line results from high-dose (50mg) fed/fast study of lead asset CTx-1301 for ADHD. News release. April 29, 2025. Accessed July 29, 2025. https://www.cingulate.com/news-releases/news-release-details/cingulate-announces-positive-top-line-results-high-dose-50mg