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  1. Home - Cingulate Inc

    Cingulate is a clinical stage biopharmaceutical company focused on the development of innovative new product candidates for the treatments of Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety …

  2. Cingulate Inc. Reports Third Quarter 2025 Financial Results and ...

    Nov 13, 2025 · “Cingulate has made meaningful progress this quarter toward key value-creating milestones,” said Jay Roberts, Executive Chairman of Cingulate.

  3. About Cingulate®

    Cingulate is a clinical stage biopharmaceutical company focused on the development of innovative new product candidates for the treatments of Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety …

  4. Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing …

    Jul 29, 2025 · With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product …

  5. Cingulate Inc. Reports Second Quarter 2025 Financial Results and ...

    Aug 19, 2025 · About CTx-1301 Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active …

  6. Efficacy Results Announced from Cingulate’s Phase 3 Pediatric Study of ...

    May 20, 2025 · Last month Cingulate announced positive top-line results of a high dose (50-mg) food effect study for CTx-1301, with the primary endpoints establishing that it can be taken with or without …

  7. FDA Accepts Cingulate’s New Drug Application for CTx-1301 in …

    Oct 14, 2025 · Cingulate’s lead candidate, CTx-1301, is in late-stage development for ADHD, with additional candidates in anxiety and other neuropsychiatric indications. Cingulate is headquartered in …

  8. Press Releases - Cingulate Inc

    Nov 10, 2025 · Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients KANSAS CITY, Kan., Aug. 06, 2025 …

  9. Final Study Completed for Cingulate’s Lead Asset CTx-1301 - Cingulate …

    Jan 7, 2025 · The subjects in the study were given a single 50mg dose of CTx-1301, Cingulate’s highest dosage, to determine if the medication can be taken in fed and fasted states. No serious adverse …

  10. CTx-1301 - Cingulate Inc

    CTx-1301 utilizes Cingulate’s innovative Precision Timed Release™ (PTR™) drug delivery platform technology to create a breakthrough multi-core formulation of dexmethylphenidate, a compound …