Product Description
ML-004 is being developed by MapLight Therapeutics for the treatment of autism spectrum disorder. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT05081245?term=ML-004&draw=2&rank=1)
Mechanisms of Action: 5-HT1B Agonist
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: MapLight Therapeutics
Company Location: Western America
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
- Clinical Outcomes Expected - MapLight Therapeutics announced they will present P2 Autism Spectrum Disorder results in 3Q26 for ML-004
Highest Development Phases
Phase 2: Autism Spectrum Disorder
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05081245 |
ML-004-002 | P2 |
Active, not recruiting |
Autism Spectrum Disorder |
2026-10-01 |
12% |
2025-12-05 |
Primary Endpoints |
NCT05889273 |
ML-004-003 | P2 |
Enrolling by invitation |
Autism Spectrum Disorder |
2027-11-01 |
12% |
2025-03-18 |
Primary Completion Date|Primary Endpoints |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/09/2026 |
News Article |
MapLight Therapeutics Updates Expected Timing of Topline Results for Ongoing Phase 2 Studies to Q3 2026 |
|
12/19/2024 |
News Article |
Sun Peak Metals to Continue Next Phase of Work on the Shire Copper-Gold VMS Project |
|
05/28/2024 |
News Article |
Sun Peak Metals Announces Encouraging Assay Results from 2020 Drill Program |
|
11/23/2020 |
News Article |
MapLight Therapeutics Announces Completion of Dosing in Phase 1 Study of Therapy for Social Deficit in Autism Spectrum Disorder |