- CEO
- Shane J. Schaffer
- Full Time Employees
- 14
- Sector
- Healthcare
- Industry
- Biotechnology
- Address
- 1901 West 47th Place Kansas City KS United States of America 66205
- IPO Date
- Dec 8, 2021
- Business
- Cingulate Inc. is a biopharmaceutical company specializing in the development of next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology. The company’s core offerings focus on treatments for attention deficit hyperactivity disorder (ADHD) and anxiety disorders, with its lead product candidate CTx-1301 designed to provide enhanced symptom control through a once-daily dosing regimen. CTx-1301 leverages PTR technology to optimize the timing and release of active pharmaceutical ingredients to improve efficacy and reduce side effects. Cingulate also applies advanced formulation techniques such as spray dried dispersions, particle engineering, multi-particulate dosage forms, and modified release technologies to enhance pharmacokinetics and bioavailability. The company maintains a network of specialized manufacturing facilities in the United States to support clinical and commercial-scale production.
Founded in Kansas City, Missouri, Cingulate operates primarily in the U.S. market and focuses on delivering pharmaceutical solutions for commonly diagnosed conditions requiring improved daily dosing regimens and outcomes. Recent major developments include the submission and FDA acceptance of a New Drug Application (NDA) for CTx-1301, with a PDUFA decision expected on May 31, 2026. This milestone follows the presentation of positive Phase 3 pediatric data demonstrating rapid onset and sustained symptom control without serious adverse events. Cingulate secured an exclusive manufacturing partnership with Bend Bio Sciences for the commercial supply of CTx-1301, extending through 2028. The company has strengthened its commercial leadership with the appointment of a Chief Commercial Officer and completed a $6 million financing round via an unsecured promissory note to extend its cash runway into the second quarter of 2026. Additionally, the FDA granted a $4.3 million fee waiver for the PDUFA, facilitating the regulatory process.
Cingulate’s strategic focus continues on expanding its clinical-stage pipeline by leveraging its PTR platform to develop additional candidates beyond ADHD and anxiety, aiming to address other therapeutic areas that benefit from precise, timed drug delivery. The company’s approach is geared towards improving therapy adherence, efficacy, and patient quality of life through innovative pharmaceutical technology. Cingulate is publicly listed on NASDAQ under the ticker CINGW and remains committed to advancing its product pipeline through ongoing clinical development, strategic partnerships, and operational scaling within the biopharmaceutical industry.