ADHD Drug CTx-1301 Receives Complete Response Letter
Company says the agency requested additional Chemistry, Manufacturing and Controls information.
By
Kathryn Wighton
June 2, 2026
Clinical Scorecard: ADHD Drug CTx-1301 Receives Complete Response Letter
At a Glance
Category Detail
Condition Attention-Deficit/Hyperactivity Disorder (ADHD) Key Mechanisms Dexmethylphenidate hydrochloride with a multi-core tablet design for timed release. Target Population Individuals diagnosed with ADHD. Care Setting Clinical settings where ADHD is diagnosed and treated.
Key Highlights
CTx-1301 received a Complete Response Letter from the FDA. FDA's feedback focused on Chemistry, Manufacturing and Controls (CMC) requests. No current concerns related to clinical safety or efficacy were identified. CTx-1301 is designed for once-daily administration with three timed releases. The product is being evaluated under the FDA’s 505(b)(2) pathway. Guideline-Based Recommendations
Diagnosis
ADHD diagnosis should follow established clinical criteria. Management
CTx-1301 remains investigational and is not yet approved for ADHD. Monitoring & Follow-up
Monitor for efficacy and safety once approved. Risks
No specific risks identified in the FDA's response. Patient & Prescribing Data
Patients with ADHD awaiting treatment options.
CTx-1301 aims to provide a controlled release of medication throughout the day.
Clinical Best Practices
Follow FDA guidelines for investigational drugs. Ensure comprehensive evaluation of ADHD treatments. Related Resources & Content
