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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05889273 | ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD) | PHASE2 | ENROLLING BY_INVITATION | 120 | — | — | Jun 1, 2023 | Dec 1, 2027 | Mar 16, 2026 | 21 | United States, Australia +1 |
| NCT05081245 | ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD) | PHASE2 | COMPLETED | 168 | — | — | Sep 13, 2022 | Apr 17, 2026 | May 19, 2026 | 29 | United States, Australia +1 |
Change from baseline in the ABI-Social Communication Domain Score will be reported. The ABI is a 62-item questionnaire for reporting the behaviors of subjects (ages: 3 years-adulthood) diagnosed with ASD. The tool is suitable for completion by parents or care/study partners of people with ASD. Each item assesses either quality (from not at all to without help) or frequency (never to very often) of a particular behavior. The Social Communication domain score is the sum of the scores in the social communication domain divided by the number of items in the domain.
| Arm | Type | Description |
|---|---|---|
| ML-004 (IR)/(ER) tablet | EXPERIMENTAL | ML-004 is a bilayer immediate-release (IR)/extended-release (ER, gastroretentive) oral tablet formulation. ML-004 is taken orally once daily and provided as a tablet in two dose strengths of 12 mg (3 mg IR/9 mg ER) and 24 mg tablet (6 mg IR/18 mg ER). Dose levels for this study are 12 mg (provided as one 12 mg tablet), 24 mg (one 24 mg tablet), 48 mg (two 24 mg tablets), and 72 mg (three 24 mg tablets). |
| ML-004 Placebo | PLACEBO_COMPARATOR | Matched placebo oral tablets will consist of same excipients as the investigational drug but without any ML-004. Placebo taken orally once daily to match tablet number of ML-004 dose levels for 12 mg (1 tablet), 24 mg (1 tablet), 48 mg (2 tablets), and 72 mg (3 tablets). |
| Name | Type | Description |
|---|---|---|
| ML-004 (IR)/(ER) tablet | DRUG | Participants will receive ML-004 once daily. |
| ML-004 Placebo | DRUG | Participants will receive matching placebo once daily. |
Inclusion Criteria: * Has completed Study ML-004-002 within the past 90 days * Age 12 years to 46 years at screening * Has a designated care/study partner who can reliably report on symptoms * Has a diagnosis of Autism Spectrum Disorder (ASD) * Has a body mass index (BMI) ≥18 kg/m² * Psychoactive m...
| 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 |