Cingulate is developing its Precision Timed Release (PTR) technology to deliver ADHD drugs 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. A fed/fast study & additional stability data are needed before FDA submission and approval which is expected in 2025. Other candidates include CTx-1302 (dextroamphetamine) for ADHD and CTx-2103 (buspirone) 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. An agreement with Indegene has been signed which will support commercialization of CTx-1301. Cingulate maintains the option to partner with others or be bought out without further obligation to Indegene.

12 Nov 2024
CING: Third Quarter Results

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CING: Third Quarter Results
Cingulate is developing its Precision Timed Release (PTR) technology to deliver ADHD drugs 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. A fed/fast study & additional stability data are needed before FDA submission and approval which is expected in 2025. Other candidates include CTx-1302 (dextroamphetamine) for ADHD and CTx-2103 (buspirone) 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. An agreement with Indegene has been signed which will support commercialization of CTx-1301. Cingulate maintains the option to partner with others or be bought out without further obligation to Indegene.