Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTx-1301- Dexmethylphenidate · 1 trial · 4 indications
The Permanent Product Measure of Performance-Correct (PERMP-C) is an objective, validated, skill-adjusted 10-minute math test that measures attention and accuracy in ADHD. Performance is measured by the number of math problems answered correctly. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.
| Arm | Type | Description |
|---|---|---|
| 25mg CTx-1301 (Dexmethylphenidate tablet) | ACTIVE_COMPARATOR | All subjects will be titrated to their optimal dose during the dose-optimization phase. The starting dose for all subjects at Day 0 is 25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
| 37.5mg CTx-1301 (Dexmethylphenidate tablet) | ACTIVE_COMPARATOR | All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
| 50mg CTx-1301 (Dexmethylphenidate tablet) | ACTIVE_COMPARATOR | All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg . Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase. |
| Name | Type | Description |
|---|---|---|
| CTx-1301 - Dexmethylphenidate 25mg | DRUG | 25mg CTx-1301 (Dexmethylphenidate tablet) |
| CTx-1301 - Dexmethylphenidate 37.5mg | DRUG | 37.5mg CTx-1301 (Dexmethylphenidate tablet) |
| CTx-1301 - Dexmethylphenidate 50mg | DRUG | 50mg CTx-1301 (Dexmethylphenidate tablet) |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Male or female subjects between 18 and 55 years of age (inclusive) at the time of consent. 2. Subject must have a body mass index (BMI) ≥18.5 and ≤40. 3. Subject is unsatisfied with his/her current pharmacological therapy for treatment of ADHD or not currently receiving pharm...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
CTx-1301 is an investigational small molecule being developed for the treatment of attention deficit hyperactivity disorder (ADHD). It is a dexmethylphenidate-based therapy designed to address symptoms of ADHD, including inattentiveness, hyperactivity, and impulsivity. The drug is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.
CTx-1301 contains dexmethylphenidate, which works by targeting the central nervous system to affect certain neurotransmitters involved in attention and behavior. Specifically, it inhibits the reuptake of dopamine and norepinephrine, increasing their levels in the brain, which helps improve focus and reduce impulsivity in individuals with ADHD.
CTx-1301 is being developed by Cingulate Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol CING. The company is focused on creating therapies for psychiatric and neurological conditions, with CTx-1301 being one of its lead product candidates for ADHD.
CTx-1301 is currently in Phase 3 clinical development. A Phase 3 study has been completed, evaluating the efficacy and safety of the drug in adults with ADHD. As of now, CTx-1301 remains investigational and has not received FDA approval, as it is still undergoing clinical trials to establish its safety and effectiveness.
CTx-1301 has one completed Phase 3 clinical trial registered under NCT05631626. This study, titled 'Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301,' was a randomized, double-blind, placebo-controlled trial conducted in the United States. It enrolled 26 adult participants aged 18 years and older with ADHD.
CTx-1301 is a formulation of dexmethylphenidate, which is the active pharmaceutical ingredient in the drug. While dexmethylphenidate is a well-known medication for ADHD, CTx-1301 is a proprietary product being developed by Cingulate Inc. with a specific delivery profile. It is not the same as generic dexmethylphenidate products.