CING | Nasdaq Listed
A group of people having a meeting

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, is being developed to serve the roughly $5 billion U.S. anxiety market.

Pipeline Overview

Cingulate® completed a proof-of-concept trial in human subjects to validate its Precision Timed Release™ (PTR™) drug delivery platform and in June 2019, announced positive results from a Phase 1/2 study of CTx-1301 (dexmethylphenidate) in ADHD patients establishing safety, tolerability, comparative bioavailability, and dose proportionality versus Focalin® XR.

Cingulate currently has three (3) product candidates, CTx-1301 (dexmethylphenidate), CTx-1302 (dextroamphetamine) and CTx-2103 (anxiety) in the pipeline. All three therapies utilize Cingulate’s innovative Precision Timed Release™ (PTR™) drug delivery platform technology. The two initial candidates are designed to fulfill long-standing unmet needs of patients with ADHD. No known competitive product currently in development is poised to overcome all unmet needs:

  • Entire active-day duration and fast onset of action
  • Elimination of need for a ‘booster/recovery’ dose of short-acting stimulant medication
  • Improved tolerability including minimization or elimination of rebound/crash symptoms associated with early medication 'wear-off'

Cingulate initiated a Phase 3 adult dose-optimization study to assess the onset and duration of efficacy and safety of CTx-1301 in adults with ADHD. The data was presented by Dr. Ann Childress at the October 2023 Psych Congress in Nashville, TN. Cingulate also initiated a CTx-1301 Phase 3 fixed-dose pediatric and adolescent safety and efficacy study in mid-2023 which based on FDA guidance has been completed. The data will be compiled and submitted as part of the clinical data package for the CTx-1301 NDA.

Cingulate® also intends to utilize its PTR™ technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas where two or more active pharmaceutical ingredients (API) need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies.

Cingulate® has completed a human formulation trial in human subjects for our third candidate, CTx-2103, to treat anxiety disorders. The data was presented by Dr Matthew Brams at the Psych Congress in October 2022 in Philadelphia PA. CTx-2103 contains one of the most widely prescribed anxiolytic agents which must be taken several times a day. In 2020, United States sales for this API accounted for over $2 billion in the $5.2 billion anxiety market. CTx-2103 will be designed as a once-daily, multi-release tablet with clear differentiation and compelling advantages over standard treatment options.

1
  • Allowing ADHD patients to pay for one medication versus two
  • Allowing payers to reimburse for one ADHD medication versus two
  • CTx-2103 (buspirone hydrochloride) is being developed for the treatment of anxiety. The once daily patient focused development product is currently under investigation.

Erosion Barrier Layer (EBL) formulation OralogiK ™ is licensed from BDD Pharma.