Phase 3 trial of CTx-1301 releases positive data, helping to achieve new breakthroughs in the treatment of children with ADHD

On 2025Maymonth20, Cingulatebiopharmaceutical company announced a plan forADHD). The results showed that the new drug CTx-1301 developed by the company significantly improved the patients' ADHD symptoms in different dosage groups, and in just 5 showed a strong therapeutic effect within 5 weeks, with effect values ranging from 0.737 to 1.185. If the drug is approved by the U.S. FDA, it is expected to become a first-line option to meet the unmet treatment needs of children and adolescent ADHD patients around the world.

CTx-1301 is an innovative patented preparation of dexmethylphenidate. Dexmethylphenidate, as a central nervous system stimulant, can enhance the activity of norepinephrine and dopamine in the brain and has been widely used in the treatment of ADHD. Different from traditional sustained-release preparations, CTx-1301 adopts a unique three-stage release technology to accurately release the active ingredients according to the predetermined time and proportion. Therefore, it takes effect more quickly and lasts longer, which helps to improve the convenience of patients taking the medicine and the stability of the efficacy.

The clinical trial announced this time is a randomized, double-blind and placebo-controlledCTx-1301-005trial (ClinicalTrials.govNo.NCT05286762), the selected patients are all from 6 to 17 years old, and after strict screening, must meet the ADHD rating scale (ADHD-RS-5) score28< /span> points and above, and the clinical global impression severity (CGI-S) score 4 points or higher are moderate and above condition criteria. In the study, 103 patients were randomly assigned to receive different doses of CTx-1301 (18.75mg, 25mg, 37.5mg) or placebo, with a treatment period of 5 weeks. Patients started from 12.5mg dose at the beginning of treatment and gradually adjusted to the target dose.

The primary assessment metric of the trial is the change from baseline in ADHD-RS-5 scores at 5weeks. The results showed that all CTx-1301 dosage groups were significantly better than the placebo group in reducing the severity of ADHD symptoms, with statistical significance of P=0.018 (18. 75mg), P=0.011 (25mg) and P=0.001 (37.5mg). In addition, the Clinical Global Impression Improvement Scale (CGI-I) score also showed significant improvement in the patient's symptoms. In terms of effect value, the improvement in the 37.5mg dose group was the most significant, reaching a high value of 1.185. The overall average effect value was 0.901, reflecting that the drug has good efficacy at different doses.

In addition to efficacy data, CingulateBiopharma also disclosed the safety profile of CTx-1301. Multiple clinical trial results released in March this year showed that the drug's safety performance was stable and no new safety warnings emerged. At the same time, the company also released the results of the food effect study of the 50 mg high-dose group, confirming that CTx-1301 can be taken with or without food, providing patients with greater flexibility in daily use. Combining comprehensive data from adult and pediatric patients, Cingulate expects to submit a new drug application (NDA) to the FDA this summer, laying the foundation for the launch of CTx-1301.

Overall,CTx-1301’s Phase 3 trial results bring new treatment hope to ADHD pediatric patients. Its rapid onset of action, long-term maintenance and good safety are expected to improve patients' quality of life and solve the shortcomings of current therapeutic drugs on the market. With the advancement of new drug applications, CTx-1301 is expected to become an important treatment option in the management of children and adolescentsADHD in the future.

References:Efficacy results announced from Cingulate’s phase 3 pediatric study of CTx-1301 (dexmethylphenidate) for ADHD. News release. Cingulate. May 20, 2025.