- Cingulate Inc CING is preparing to initiate a Phase 3 adult dose-optimization study later this year for its lead candidate, CTx-1301, to assess the onset and duration of efficacy and safety in adults with Attention Deficit / Hyperactivity Disorder (ADHD).
- The study is expected to commence in December 2022.
- The company executed a Master Services Agreement with Societal CDMO Inc SCTL to manufacture all clinical, registration, and commercial batches of Cingulate's lead candidate CTx-1301, an investigational medication for ADHD.
- In addition, the CTx-1301 Phase 3 fixed-dose pediatric and adolescent safety and efficacy study is now expected to commence in mid-2023 after the final two dosage strengths for this study are completed by Societal CDMO.
- Earlier this year, Cingulate expected to start the fixed-dose study in Q2 of 2022.
- Assuming positive clinical results from Phase 3 trials and the food effect study with data expected in December 2022, the company plans to submit a marketing application to the FDA in 1H of 2024 under the Section 505(b)(2) pathway.
- Price Action: CING shares closed 14.3% lower at $0.90 during after-hours trading on Monday.
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