Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06126653 | A Study to Evaluate ARD-501 in Patients With Autism Spectrum Disorder | PHASE2 | COMPLETED | 5 | — | — | Aug 1, 2024 | Jan 13, 2025 | May 9, 2025 | 1 | United States |
To measure the efficacy evaluation of safety in subjects with autism spectrum disorder (ASD) by assessment of the incidence of Treatment-Emergent Adverse Events (TEAE).
| Arm | Type | Description |
|---|---|---|
| Phase 1: Low Dose | EXPERIMENTAL | ARD-501 for 7 days at 0.2 mg/kg |
| Phase 2: Placebo | PLACEBO_COMPARATOR | Placebo for 7 days |
| Phase 2: High Dose | EXPERIMENTAL | ARD-501 for 7 days at 0.5 mg/kg |
| Phase 2: Crossover Placebo to High Dose | EXPERIMENTAL | ARD-501 for 7 days at 0.5 mg/kg |
| Phase 2: Crossover High Dose to Placebo | PLACEBO_COMPARATOR | Placebo for 7 days |
| Name | Type | Description |
|---|---|---|
| Low Dose ARD-501 | DRUG | Titratable, liquid formulation, taken orally. The intervention is given relative to the body weight of the individual. 0.2 mg/kg dosing. |
| High Dose ARD-501 | DRUG | Titratable, liquid formulation, taken orally. The intervention is given relative to the body weight of the individual. 0.5 mg/kg dosing. |
| Placebo | DRUG | Titratable, liquid formulation, taken orally. |
Inclusion Criteria: Subjects must meet all the following criteria to be eligible for participation in this study: * Male and female subjects, 17-30 years of age * Able and willing to sign consent and comply with study protocol * Diagnostic confirmation of ASD as confirmed by gold standard clinical...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 3 | PHASE3 | KarXT, KarX-EC |
| MapLight Therapeutics, Inc. | MPLT | 1 | PHASE2 | ML-004 / |
| Definium Therapeutics, Inc. | DFTX | 1 | PHASE2 | DT402 ) |
| Plus Therapeutics, Inc. | PSTV | 1 | NA | Undisclosed |
| SciSparc Ltd. | SPRC | 1 | NA | SCI-210, CBD oil |
| Journey Medical Corp. | DERM | 1 | — | Undisclosed |