CING | Nasdaq Listed
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Pipeline

Cingulate currently has two (2) product candidates, CTX-1301 and CTX-1302, that are being developed to serve the approximate $22.1 billion annual U.S. ADHD market. A third product candidate, CTx-2103 (buspirone), is being developed for the anxiety market. In 2025, U.S. buspirone sales exceeded $1 billion within the broader $15.2 billion anxiety and depression market.

Pipeline Overview

Cingulate has two proprietary, first line stimulant medications: CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), that are being developed for the treatment of ADHD across all three patient segments: children (ages 6-12), adolescents (ages 13-17), and adults (ages 18+). Both CTx-1301 and CTx-1302 are designed to address the key shortcomings of currently approved stimulant therapies by:

  • Providing near-immediate onset (within 30 minutes)
  • Delivering all-day efficacy
  • Eliminating the need for “booster” doses
  • Reducing rebound/crash effects
  • Offering favorable tolerability with controlled drug level decline


Futhermore, by eliminating the ‘booster’ dose, we believe our product candidates will provide important societal and economic benefits by:

  • Reduce abuse and diversion risks
  • Simplify prescribing (one medication instead of two)
  • Lower patient costs
  • Streamline payer reimbursement

Cingulate submitted an NDA to the FDA for its lead candidate, CTx-1301, on July 31, 2025.

The Company is also developing CTx-2103 (buspirone) for anxiety, a highly prevalent mental health condition in the U.S. According to OptumRx data, patients take an average of 2.3 doses of buspirone daily.

Cingulate has also embarked on a program to develop CTx-2103 (buspirone), for the treatment of anxiety, which is one of the most common mental health concerns in the United States. According to OptumRx Commercial data, the average patient takes 2.3 doses of buspirone per day. CTx-2103 is being designed as a true, once-daily administration of buspirone that incorporates our proprietary Precision Timed Release (PTRtm )drug delivery platform technology. Buspirone, an azapirone derivative and a 5-HT1A partial agonist, was the first non-benzodiazepine anxiolytic introduced for the treatment of generalized anxiety disorder. Buspirone by exhibit a decreased side-effect profile compared to other anxiolytic treatments. Unlike benzodiazepines and barbiturates, there is no associated risk of physical dependence or withdrawal with buspirone use due to lack of effects on gamma-aminobutyric acid receptors. Furthermore, buspirone is not regulated as a controlled substance by DEA or under the Controlled Substances Act of 1970 (the “CSA”).

Cingulate plans to initiate clinical trials for CTx-2103 in Q4 2026.