Cingulate Inc (NASDAQ: CING) is a clinical-stage pharmaceutical company developing a prescription stimulant medication for attention deficit hyperactivity disorder (ADHD). The company has generated no revenue since inception and funds operations entirely through capital raises. Its lead and sole disclosed product candidate, CTx-1301, is a triple-pulse dextroamphetamine formulation designed for extended release over more than eight hours. Cingulate submitted a New Drug Application (NDA) to the FDA on July 31, 2025, which was accepted for review on September 29, 2025, with a PDUFA target action date of May 31, 2026. The company holds an exclusive worldwide patent and know-how license from BDD Pharma Limited, executed in August 2018, covering barrier-layer controlled-release technology for methylphenidate-based and amphetamine-based drugs. A final milestone payment of $250,000 to BDD Pharma is due upon FDA approval of CTx-1301, with royalties owed on future sales. Cingulate's auditors have issued a going-concern opinion as of the 10-K filed March 18, 2026, citing losses and negative cash flows from operations since inception. The company is headquartered in Kansas City, Kansas.

Revenue model

Cingulate has generated no revenue as of the 10-K filed March 18, 2026. The intended future revenue model is prescription drug sales of CTx-1301 upon FDA approval, subject to royalty obligations to BDD Pharma Limited under the 2018 license agreement.

Products and services

CTx-1301: a triple-pulse dextroamphetamine extended-release tablet targeting ADHD in adults, adolescents, and pediatric patients. Phase 3 adult dose-optimization study completed June 2023. NDA submitted July 31, 2025; PDUFA date May 31, 2026. Manufactured by Bend Bioscience (CDMO) under a process validation agreement with a total estimated cost of approximately $7.0 million.

Customers and end markets

Target end market is patients diagnosed with ADHD, including adults, adolescents, and pediatric populations. Prescribers are physicians. Third-party payors (insurers) are a material adoption factor. No commercial sales have occurred as of the filing date.

Value-chain role

Drug developer and NDA holder. Relies on contract research organizations (CROs) for clinical trials and Bend Bioscience as its contract development and manufacturing organization (CDMO). Holds an exclusive in-license from BDD Pharma Limited for the underlying controlled-release platform technology.

Geographic exposure

Headquartered in Kansas City, Kansas. The BDD Pharma license grants worldwide commercialization rights. All clinical and regulatory activity disclosed in the filing is U.S.-focused, with FDA as the relevant regulatory authority.

Source: SEC 10-K, filed 2026-03-18

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