This section highlights FDA-related milestones and regulatory updates for drugs developed by Maplight Therapeutics (MPLT).
Over the past two years, Maplight Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ML-004-002 and ML-007C-MA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ML-004-002 FDA Regulatory Events
ML-004-002 is a drug developed by Maplight Therapeutics for the following indication: in autism spectrum disorder (ASD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ML-004-002
- Announced Date:
- June 22, 2026
- Indication:
- in autism spectrum disorder (ASD).
Announcement
MapLight Therapeutics, Inc announced topline results from IRIS (ML-004-002), a Phase 2 study of ML-004 in autism spectrum disorder (ASD). The study randomized 161 participants (102 adolescents, 59 adults), with prespecified analyses planned by age group and baseline irritability severity..
AI Summary
MapLight Therapeutics said its Phase 2 IRIS study of ML-004 in autism spectrum disorder did not meet the main goal of improving social communication deficits. The trial enrolled 161 people, including 102 adolescents and 59 adults, and planned separate analyses by age and by how severe irritability was at the start. Even though the study missed its primary endpoint, ML-004 was generally well tolerated. No severe or serious side effects were reported in the active-treatment group, and no extrapyramidal events were seen. The most common side effects were headache, nausea, sleepiness, vomiting, fatigue, and dizziness, and they were mostly mild to moderate. Adolescents had fewer side effects than adults overall. Mean weight gain was also lower with ML-004 than with placebo. The company said it will review the data and then move forward with its clinical development plans.
Read Announcement
ML-007C-MA FDA Regulatory Events
ML-007C-MA is a drug developed by Maplight Therapeutics for the following indication: for Alzheimer's Disease Psychosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ML-007C-MA
- Announced Date:
- May 1, 2026
- Indication:
- for Alzheimer's Disease Psychosis
Announcement
MapLight Therapeutics, Inc announced completion of enrollment in its Phase 2 ZEPHYR trial evaluating ML-007C-MA for the treatment of schizophrenia.
AI Summary
MapLight Therapeutics announced completion of enrollment in its Phase 2 ZEPHYR trial testing ML-007C-MA for schizophrenia. ZEPHYR is a randomized, double-blind, placebo-controlled study evaluating the drug’s efficacy, safety, and tolerability in inpatient adults experiencing an acute exacerbation of psychosis. With enrollment finished and patients being followed, MapLight expects topline results from ZEPHYR by mid‑August 2026.
The company also reported the last patient visit has been completed in its IRIS Phase 2 trial of ML-004 for autism spectrum disorder, which enrolls adults and adolescents and uses a similar randomized, double-blind, placebo-controlled design. Topline data from both Phase 2 trials are anticipated by mid‑August 2026. For more information, visit MapLight’s website.
Read Announcement- Drug:
- ML-007C-MA
- Announced Date:
- January 5, 2026
- Indication:
- for Alzheimer's Disease Psychosis
Announcement
MapLight Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an investigational novel M1/M4 muscarinic agonist, for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP).
AI Summary
MapLight Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track designation to ML-007C-MA, an investigational M1/M4 muscarinic agonist being developed to treat hallucinations and delusions in Alzheimer’s disease psychosis (ADP). Fast Track status is intended to speed development and review of treatments for serious conditions with unmet needs.
ML-007C-MA is an oral, extended‑release, fixed‑dose combination of the central M1/M4 agonist ML‑007 co‑formulated with a peripherally acting anticholinergic (PAC). The design aims to activate brain M1 and M4 receptors to improve psychotic symptoms while reducing peripheral cholinergic side effects by synchronizing the two components’ effects.
In Phase 1, ML‑007C‑MA showed a generally favorable safety and tolerability profile with twice‑daily dosing in healthy older adults. The randomized, double‑blind, placebo‑controlled Phase 2 VISTA study is ongoing, plans to enroll about 300 participants, and expects topline results in the second half of 2027.
Read Announcement
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