ADHD Drug CTx-1301 Receives Complete Response Letter
Company says the agency requested additional Chemistry, Manufacturing and Controls information.
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By
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Kathryn Wighton
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June 2, 2026
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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.
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