Trial Profile

A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 29 Jun 2026

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At a glance

22 Jun 2026 According to a MapLight Therapeutics media release, Following a full review of the data, the Company expects to engage with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 2 meeting to determine the clinical development path forward, Company to host live webcast today at 8:00 AM ET
22 Jun 2026 Primary endpoint (Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score) has not been met as per MapLight Therapeutics media release.
22 Jun 2026 Results published in the MapLight Therapeutics Media Release

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