CTx-2103

Product Description

CTx-2103 utilizes a breakthrough multi-core formulation of buspirone, an FDA-approved treatment for anxiety.

Clinical Trials

CTx-2103 will be designed as a once-daily, modified-release tablet with clear differentiation and compelling advantages over standard treatment options which must be taken multiple times per day to maximize efficacy.

Cingulate completed a proof-of-concept study in which pharmacokinetics were evaluated for a trimodal tablet providing three precisely timed doses of buspirone. In addition, scintigraphic imaging visualized transit of the tablet through the gastrointestinal tract to confirm both the site and onset of release, which was then correlated with pharmacokinetic data to establish the full release profile of the CTx-2103 formulation. Based on the pharmacokinetic profile seen in the data, CTx-2103 achieved a triple release of buspirone. These results provided the critical information required to complete a Pre-IND meeting with FDA to discuss the design of the clinical and regulatory program. Cingulate plans to initiate clinical trials in 4Q 2026.