- **Cingulate Inc.** announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for **CTx-1301**, a lead candidate for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults.  **[1862150_0001493152-25-017931_ex99-1.htm:0]** **[1862150_0001493152-25-017931_form8-k.htm:1]** **[1862150_0001493152-25-017931_form8-k.htm:2]** 
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of **May 31, 2026**, for the review of CTx-1301.  **[1862150_0001493152-25-017931_ex99-1.htm:0]** **[1862150_0001493152-25-017931_form8-k.htm:1]** **[1862150_0001493152-25-017931_form8-k.htm:2]** 
- CTx-1301 is a once-daily Precision Timed Release™ (PTR™) stimulant, and its NDA was accepted under the FDA's **505(b)(2) regulatory pathway**.  **[1862150_0001493152-25-017931_ex99-1.htm:0]** **[1862150_0001493152-25-017931_ex99-1.htm:1]** 
- This acceptance is a significant regulatory milestone, positioning Cingulate to potentially transition from a development-stage to a commercial-stage company in **2026**, pending FDA approval.  **[1862150_0001493152-25-017931_ex99-1.htm:1]**

Cingulate's New Drug Application for CTx-1301 in ADHD Accepted by FDA

- **Cingulate Inc.** announced that the **FDA has accepted for review** its New Drug Application (NDA) for **CTx-1301** (dexmethylphenidate), its lead candidate for the treatment of **Attention-Deficit/Hyperactivity Disorder (ADHD)** in children and adults.  **[1862150_cf53a60f3fff4e47824eee78e124eac8_1]** 
- The NDA was accepted under the FDA’s **505(b)(2) regulatory pathway**.  **[1862150_cf53a60f3fff4e47824eee78e124eac8_0]** **[1862150_cf53a60f3fff4e47824eee78e124eac8_1]** 
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of **May 31, 2026**.  **[1862150_cf53a60f3fff4e47824eee78e124eac8_1]** 
- CTx-1301 is a **once-daily Precision Timed Release™ (PTR™) stimulant** designed for rapid onset and entire active-day duration, which demonstrated improved ADHD symptoms and sustained efficacy in adult and pediatric Phase 3 clinical trials.  **[1862150_cf53a60f3fff4e47824eee78e124eac8_0]** **[1862150_cf53a60f3fff4e47824eee78e124eac8_1]** 
- This milestone positions Cingulate to potentially transition to a **commercial-stage company in 2026**, pending FDA approval, and the company is advancing commercial readiness activities.  **[1862150_cf53a60f3fff4e47824eee78e124eac8_2]**

Cingulate (CING)