CING News & Events

Cingulate announced the issuance of its first company-owned U.S. patent covering its lead asset, CTx-1301, for the treatment of Attention Deficit Hyperactivity Disorder, or ADHD. The patent, issued by the United States Patent and Trademark Office, or USPT, on June 16, as U.S. Patent No. 12,653,791, protects key aspects of CTx-1301's formulation and method of use through December 2042.

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Cingulate announced that the FDA has issued a complete response letter for its new drug application for CTx-1301 for the treatment of Attention Deficit/Hyperactivity Disorder, or ADHD. The response identified specific Chemistry, Manufacturing and Controls information requests and did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301. Cingulate expects a prompt submission to FDA of the requested information addressing issues raised. "We are encouraged that the FDA's response was limited to specific information requests related to CMC and did not currently identify any issues related to the clinical safety or efficacy of CTx-1301," said Cingulate CEO Shane Schaffer. "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."