Cingulate is developing its Precision Timed Release (PTR) technology to deliver ADHD medicines to improve onset & efficacy of previously approved products. It licensed rights to manufacturing a 3-layer tablet that releases dexmethylphenidate (CTx-1301) over the active day. CTx-1301 provides immediate onset, eliminates the need for a booster dose, reduces diversion & simplifies dosing among other benefits. This addresses a large market encompassing ~93 million US ADHD scripts in 2023. Phase III clinical work has shown an impressive size effect, safe use of CTx-1301 & evidence of all day coverage. Cingulate's candidates will pursue the 505(b)(2) regulatory path used for a new release mechanism & approved underlying API. In July 2025, the NDA was submitted. Other candidates include CTx-1302 (dextroamphetamine) for ADHD and CTx-2103 (buspirone), both of which also use the PTR technology.. We may see CTx-2103 emerge as the follow-on product to -1301 due to a clear regulatory path forward. Cingulate signed an agreement with Indegene to support commercialization of CTx-1301, but maintains the option to partner with others or be bought out without further obligation to Indegene.
