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CINGULATE,INC

🇯🇵Japan
Ownership
-
Employees
-
Market Cap
$17M
Website

Clinical Trials

6

Active:0
Completed:5

Trial Phases

3 Phases

Phase 1:2
Phase 3:3
Not Applicable:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (6 trials with phase data)• Click on a phase to view related trials

Phase 3
3 (50.0%)
Phase 1
2 (33.3%)
Not Applicable
1 (16.7%)

In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted)

Not Applicable
Completed
Conditions
Healthy Volunteers in Fed and Fasted State
Interventions
First Posted Date
2025-08-12
Last Posted Date
2025-08-12
Lead Sponsor
Cingulate Therapeutics
Target Recruit Count
25
Registration Number
NCT07119073
Locations
🇺🇸

Dr. Vince Clinical Research, Overland Park, Kansas, United States

Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301

Phase 3
Suspended
Conditions
Attention Deficit Hyperactivity Disorder
Attention-deficit Hyperactivity
ADHD
ADHD - Combined Type
Attention Deficit Disorder With Hyperactivity
Attention Deficit Hyperactivity Disorder Combined
Attention Deficit Hyper Activity
Interventions
First Posted Date
2023-06-29
Last Posted Date
2025-08-14
Lead Sponsor
Cingulate Therapeutics
Target Recruit Count
45
Registration Number
NCT05924594
Locations
🇺🇸

Accel Research Sites, Maitland, Florida, United States

🇺🇸

Center for Psychiatry & Behavioral Medicine, Las Vegas, Nevada, United States

🇺🇸

Coastal Carolina Research Center, North Charleston, South Carolina, United States

Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.

Phase 3
Completed
Conditions
Attention Deficit Hyperactivity Disorder
ADHD
ADHD - Combined Type
Attention Deficit Hyperactivity Disorder Combined
Interventions
First Posted Date
2022-11-30
Last Posted Date
2025-08-14
Lead Sponsor
Cingulate Therapeutics
Target Recruit Count
21
Registration Number
NCT05631626
Locations
🇺🇸

Clinical Research of Southern Nevada, LLC, Las Vegas, Nevada, United States

Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301

Phase 3
Completed
Conditions
ADHD
Attention Deficit Hyperactivity Disorder
Attention-deficit Hyperactivity
Attention Deficit Hyper Activity
ADHD - Combined Type
Attention Deficit Hyperactivity Disorder Combined
Interventions
Drug: CTx-1301-Dexmethylphenidate 12.5 mg (titration only)
Drug: Placebo
Drug: CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose)
Drug: CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose)
Drug: CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose)
First Posted Date
2022-03-18
Last Posted Date
2025-08-15
Lead Sponsor
Cingulate Therapeutics
Target Recruit Count
103
Registration Number
NCT05286762
Locations
🇺🇸

Clinical Neuroscience Solutions, Inc., Memphis, Tennessee, United States

🇺🇸

Meridien Research, Maitland, Florida, United States

🇺🇸

Atlanta Center for Medical Research, Atlanta, Georgia, United States

and more 19 locations

Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Volunteers in Fed and Fasted State
Interventions
First Posted Date
2020-06-26
Last Posted Date
2022-10-20
Lead Sponsor
Cingulate Therapeutics
Target Recruit Count
27
Registration Number
NCT04449250
Locations
🇺🇸

Dr. Vince Clinical Research, Overland Park, Kansas, United States

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News

Cingulate Advances CTx-1301 for ADHD Treatment with Positive Phase III Safety Data and Upcoming FDA Pre-NDA Meeting

Cingulate Inc. has completed its fast-fed study and submitted safety data from Phase III trials for CTx-1301, its ADHD treatment candidate, with no serious adverse events reported in pediatric and adolescent studies.

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