Cingulate Inc. (NASDAQ:CING) has made significant progress in advancing its lead ADHD treatment candidate CTx-1301 toward FDA submission, completing critical studies and securing necessary funding to support its regulatory pathway.
The Kansas City-based biopharmaceutical company recently submitted safety results from its Phase III clinical trials to the FDA in preparation for a pre-New Drug Application (NDA) meeting scheduled for April 2nd, 2025. The submission included data from two Phase III pediatric and adolescent studies—a fixed dose study and a dose optimization study—as well as a food effect study with healthy adults using a single 50mg dose of CTx-1301.
Positive Safety Profile Demonstrated in Phase III Studies
Safety data from the Phase III trials revealed encouraging results for CTx-1301, Cingulate's novel formulation of dexmethylphenidate utilizing the company's proprietary Precision Timed Release technology. Key findings include:
- No subjects experienced serious treatment emergent adverse events (TEAEs) or TEAEs leading to death
- No clinically relevant trends in TEAEs were observed overall
- Medical findings for the 50mg dose aligned with previous studies of the 25mg dose, confirming CTx-1301 can be taken with or without food
"The safety profile demonstrated in our Phase III studies represents a significant milestone in our development program," said Shane Schaffer, CEO of Cingulate. "These results further support our confidence in CTx-1301 as a potential once-daily treatment option for ADHD patients."
Completion of Critical Fast-Fed Study
Cingulate has also completed a required fast-fed study measuring the effect of food on the absorption and bioavailability of CTx-1301 at its highest dose of 50mg. The study enrolled 26 healthy adults using a crossover design and was structured as an open-label, randomized, single-dose, two-sequence, two-period, in-clinic study.
Participants were randomized into two sequences: a fasted state and a fed state following a high-fat test meal. The primary pharmacokinetic endpoints included:
- Maximum concentration (CMAX) during the first 28 hours after dosing
- Total amount of dexmethylphenidate in the blood, expressed as the area under the plasma drug concentration-time curve
Partial data from this study has already been submitted to the FDA as part of the pre-NDA meeting package, with additional data expected in the second quarter of 2025.
Regulatory Pathway and Timeline
The company's regulatory strategy includes several parallel efforts:
- Updating stability data on 2024 batches of CTx-1301
- Completing analysis of the fast-fed study
- Attending the pre-NDA meeting with the FDA in early April 2025
Following the pre-NDA meeting, Cingulate expects to receive written notes from the FDA approximately one month later, which will provide final details required for completing the NDA submission by mid-2025. Based on typical review timelines, the company anticipates a 10-to-12-month turnaround from the FDA, potentially leading to approval by mid-2026.
Financial Position and Commercialization Strategy
In December 2024, Cingulate completed a financing round that raised net proceeds of $5 million. The funding came through a non-convertible, unsecured promissory note with a principal amount of $5,480,000, carrying a 9% annual interest rate and maturing in June 2026. These funds will support the company's clinical, manufacturing, and regulatory activities.
Looking toward commercialization, Cingulate has established a non-binding arrangement with Indegene to market the product in the United States on a fee-for-service basis. The company is also exploring co-promotion opportunities and seeking international partners to commercialize CTx-1301 outside the U.S.
"We're actively pursuing partnerships that not only expand our global reach but also provide upfront capital to support our U.S. launch," noted Schaffer. "The upcoming Drug, Chemical & Associated Technologies meeting in March presents an excellent opportunity to advance these business development discussions."
CTx-1301: Addressing Unmet Needs in ADHD Treatment
CTx-1301 is designed to address significant limitations in current ADHD treatments. The drug utilizes Cingulate's Precision Timed Release technology to deliver three releases of dexmethylphenidate throughout the day from a single morning dose, potentially providing consistent symptom control without the need for multiple daily doses.
ADHD affects approximately 6.1 million children and 10 million adults in the United States alone. While stimulant medications like methylphenidate are considered first-line treatments, many patients struggle with the need for multiple daily doses and inconsistent symptom control throughout the day.
Looking Ahead
As Cingulate approaches its pre-NDA meeting with the FDA, the company appears well-positioned to advance CTx-1301 through the final stages of development. The positive safety profile demonstrated in Phase III studies, combined with the completion of required pharmacokinetic assessments, supports the company's regulatory strategy.
With sufficient funding secured through mid-2026 and potential international partnerships on the horizon, Cingulate is preparing for the commercial launch of CTx-1301 while continuing to engage with the scientific community through upcoming conference presentations and data releases.
