The FDA issued a complete response letter for Cingulate's NDA for CTx-1301, its once-daily modified-release ADHD tablet, citing outstanding CMC requirements.
The letter did not raise any concerns regarding the clinical safety or efficacy of CTx-1301. Cingulate says it plans a “prompt submission” to FDA of the requested information addressing the issues raised.
“Our immediate priority is to complete the CMC work already underway with our manufacturing partner; we believe the outstanding requests will be addressed quickly as we move efficiently toward resubmission. Importantly, we have nearly $30 million in cash reserves, which we believe provides sufficient capital to address the issues raised and execute on the resubmission process and continue pre-commercial activities into 2027,” said Cingulate CEO Shane J. Schaffer.
CTx-1301 uses Cingulate's Precision Timed Release (PTR) platform, which packs three distinct dexmethylphenidate HCl release phases into a single tablet. The design is meant to cover morning, afternoon, and evening hours without a midday booster — addressing a real limitation of current extended-release stimulants. The NDA was accepted under the 505(b)(2) pathway in October 2025, with a PDUFA date of May 31, 2026.