Drugs / ML-004
last change Jun 2026 re-read 3 minutes ago

ML-004

Developed for
autism spectrum disorder
Investigated by
MapLight Therapeutics

Trials 2

202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT05889273 Jun 2023 → Nov 2027 expected autism spectrum disorder MapLight Therapeutics Active not recruiting No outcome recorded
Phase 2 NCT05081245 Sep 2022 → Mar 2026 autism spectrum disorder MapLight Therapeutics Completed Missed primary

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2026-06-22 MapLight Therapeutics Results MapLight Announces Topline Results from Phase 2 IRIS Study for ML-004 in Autism Spectrum Disorder maplightrx.com ↗
The IRIS Phase 2 trial did not meet its primary endpoint in social communication deficits associated with ASD

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as ML-004 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05889273 ↗
1

NCT05081245 ↗

Route Oral “ML-004 is taken orally once daily.” NCT05081245 ↗