Cingulate Inc.'s CTx-1301 Poised to Transform ADHD Treatment Landscape

The recent initiation of coverage by Stonegate Capital Partners on Cingulate Inc. (NASDAQ: CING) highlights a pivotal moment in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Cingulate's lead asset, CTx-1301, developed using the company's proprietary Precision Timed Release™ (PTR™) platform, promises to deliver a once-daily stimulant therapy with rapid onset and sustained efficacy. This innovation addresses a critical gap in current ADHD treatments, which often necessitate booster doses, thereby complicating patient adherence.

In May 2025, Cingulate reported encouraging efficacy results from its FDA-required Phase 3 fixed-dose pediatric trial for CTx-1301. The trial showcased statistically significant improvements on the ADHD-RS-5 scale across all dose levels within five weeks, with effect sizes ranging from 0.737 to 1.185. These findings, complemented by positive outcomes from a high-dose food effect study in April, underscore CTx-1301's potential to revolutionize ADHD management by enhancing treatment adherence and offering greater flexibility to patients.

Cingulate is on track to submit a New Drug Application (NDA) for CTx-1301 in mid-2025, backed by data from nine clinical trials. The company's recent pre-NDA consultation with the FDA and the submission of final Phase 3 safety results in March 2025 are significant milestones toward achieving regulatory approval. With a robust safety profile and no serious treatment-emergent adverse events reported, CTx-1301 stands out as a promising candidate that could redefine standards in ADHD treatment.

Financially, Cingulate reported $9.5M in cash and cash equivalents as of the first quarter of 2025, alongside a net loss of $3.8M for the same period. The company is actively exploring strategic financing avenues to bolster its NDA submission and pre-launch initiatives, including a $5M unsecured promissory note secured in December 2024. Stonegate Capital Partners has valued Cingulate between $13.96 and $26.96, with a midpoint of $19.09, reflecting the transformative potential of CTx-1301 in the lucrative $22B U.S. ADHD market.

The development of CTx-1301 represents a significant advancement in ADHD treatment, offering hope for improved patient outcomes and adherence. As Cingulate progresses toward commercialization, the implications for patients, healthcare providers, and the broader ADHD market are profound, signaling a new era in the management of this pervasive condition.