Cingulate Inc. Advances Toward ADHD Franchise with FDA Milestones

Cingulate Inc. (NASDAQ: CING) is making significant strides in its development of CTx-1301, a treatment aimed at addressing Attention Deficit Hyperactivity Disorder (ADHD). According to an update from Stonegate Capital Partners on November 18, 2025, the company’s third-quarter results reflect important progress toward establishing CTx-1301 as a commercial franchise in the ADHD market.

The most notable achievement for Cingulate is the FDA’s acceptance of the New Drug Application (NDA) for CTx-1301, which has a Prescription Drug User Fee Act (PDUFA) date set for May 31, 2026. This date is crucial as it indicates when the FDA is expected to make a decision regarding the drug’s approval, potentially allowing for a launch in 2026, contingent upon regulatory clearance.

Cingulate’s recent achievements include the presentation of promising Phase 3 clinical trial data. This data highlights the rapid onset of CTx-1301’s effects and its ability to provide comprehensive symptom control throughout an entire day for pediatric patients. These findings are likely to enhance the drug’s appeal in a market that seeks effective ADHD treatments.

Strategic Partnerships and Financial Position

To bolster its commercial strategy, Cingulate has executed an exclusive supply agreement with Bend Bio Sciences. This partnership aims to secure U.S. manufacturing capacity ahead of the anticipated product launch. Furthermore, the company has appointed Bryan Downey as Chief Commercial Officer, underlining its commitment to building a robust commercial infrastructure.

Financially, Cingulate reported approximately $6.1 million in cash at the end of the third quarter. A subsequent financing round raised an additional $6 million, extending the company’s operational runway into the second quarter of 2026. This financial backing is critical as Cingulate prepares for the potential launch of CTx-1301 and continues to expand its commercial capabilities.

Cingulate is also leveraging its proprietary PTR platform to address unmet needs within the expansive U.S. ADHD market. With a well-defined strategy and a focus on effective treatment solutions, the company is positioning itself to make a significant impact once CTx-1301 gains regulatory approval.

As Cingulate Inc. moves closer to its 2026 launch goal, the company remains focused on fulfilling the needs of patients and healthcare providers in the ADHD space. With the combined efforts of strategic partnerships, innovative research, and a strong financial foundation, Cingulate is set to navigate the complexities of bringing CTx-1301 to market successfully.