Cingulate secures exclusive US manufacturing deal for ADHD treatment

Cingulate Inc. (NASDAQ: CING) announced it has entered into a commercial supply agreement with Bend Bio Sciences for manufacturing of CTx-1301, its lead ADHD treatment candidate.

Under the agreement, Bend Bio Sciences will serve as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, subject to FDA approval. Cingulate has committed to purchasing 100% of its overall U.S. commercial supply of CTx-1301 from Bend following any FDA approval.

CTx-1301 is an extended-release tablet formulation of dexmethylphenidate designed using Cingulate's Precision Timed Release drug delivery platform. The company submitted its New Drug Application to the FDA for CTx-1301 on July 31, 2025.

"Following our successful NDA submission last month, this exclusive manufacturing partnership with Bend Bio Sciences marks another pivotal step in our commercialization strategy," said Jay Roberts, Executive Chairman of Cingulate.

Bend Bio Sciences Chief Executive Officer Owen Murray stated, "We're proud to expand our years-long partnership with Cingulate as they advance this important next-generation therapy into commercial manufacturing."

According to the CDC, over 20 million patients in the U.S. have been diagnosed with ADHD, including 12 million adults and over 8 million under age 17. Just 53.6 percent of children and teens with ADHD reported actively treating their symptoms with medication in 2022.

CTx-1301 utilizes a multi-core formulation designed to deliver three releases of medication at predefined times to provide patient care in one tablet. The drug contains dexmethylphenidate, a stimulant already approved by the FDA for ADHD treatment.

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