COMPANY

Cingulate Therapeutics

Cingulate Therapeutics is listed on ClinicalTrials.gov as the lead sponsor of 6 studies; the most recently updated is “Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.” (Phase 3, completed), in ADHD, ADHD - Combined Type, Attention Deficit Hyperactivity Disorder Combined. From public records Source · Oct 12, 2026

Keywords: ADHD - Combined Type Attention Deficit Hyperactivity Disorder Combined Attention Deficit Hyper Activity Attention Deficit Disorder With Hyperactivity Dexmethylphenidate

Profile checked Oct 10, 2026

6Trials (company is sponsor)

Trial and FDA signals

FDA complete response letter Received an FDA complete response letter (NDA 220283, letter dated May 29, 2026). FDA NDA 220283 (May 29, 2026)
Evidence (1 event)
- May 29, 2026 · FDA NDA 220283
  CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Cingulate Therapeutics, LLC Attention: Kelly R. Koehn Vice President, Clinical and Regulatory Operations Westwood, KS (street omitted) Dear Kelly Koehn: Please refer to your n

Job counts as of Oct 18, 2026. All trial and FDA signals

Timeline

Oct 31, 2024 Trial start Phase 1: In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted) source ↗
Aug 1, 2023 Trial start 3: Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 source ↗
Jul 31, 2023 Trial start 3: Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 source ↗
Dec 29, 2022 Trial start 3: Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. source ↗
Sep 14, 2022 Trial start Phase 1: Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects source ↗
Dec 6, 2019 Trial start Phase 1/Phase 2: CTx-1301 Comparative Bioavailability Study source ↗

Clinical trials (lead sponsor) 6

Record	Title	Phase	Status	Start	Primary completion
NCT05631626	Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.	3	Completed	Dec 29, 2022	Jun 13, 2023 (actual)
NCT05924594	Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301	3	Suspended	Jul 31, 2023	2027-02 (estimated)
NCT05286762	Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301	3	Completed	Aug 1, 2023	Feb 29, 2024 (actual)
NCT07119073	In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted)	Phase 1	Completed	Oct 31, 2024	Dec 21, 2024 (actual)
NCT04449250	Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects	Phase 1	Completed	Sep 14, 2022	Oct 14, 2022 (actual)
NCT04138498	CTx-1301 Comparative Bioavailability Study	Phase 1/Phase 2	Completed	Dec 6, 2019	Mar 6, 2020 (actual)