MapLight Therapeutics Secures Fast Track Designation from FDA for ML-007C-MA in Alzheimer's Disease Psychosis

SAN FRANCISCO and BOSTON, January 5, 2026 - MapLight Therapeutics, Inc. (Nasdaq: MPLT) has announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug, ML-007C-MA. This novel M1/M4 muscarinic agonist aims to address hallucinations and delusions linked to Alzheimer’s disease psychosis (ADP).

Understanding Fast Track Designation

The Fast Track process is designed to expedite the development and review of therapies that address serious medical conditions with significant unmet needs. Drugs receiving this designation may benefit from increased communication with the FDA, potential for accelerated approval, and priority review when certain criteria are met.

Implications of Fast Track Designation

Dr. Erin Foff, Chief Medical Officer of MapLight, remarked, “The FDA's Fast Track designation underscores the significant unmet need of the millions of people suffering from Alzheimer’s disease psychosis, who currently lack approved treatment options. This milestone for the ML-007C-MA program highlights its potential to alleviate the psychotic symptoms associated with cognitive decline in Alzheimer’s patients. We are committed to collaborating closely with the FDA to expedite this program through our ongoing Phase 2 VISTA study.”

Clinical Trials and Expectations

ML-007C-MA has exhibited a favorable safety and tolerability profile in a Phase 1 clinical trial, which involved twice-daily dosing in healthy elderly individuals. Enrollment for the Phase 2 VISTA study is currently underway. This randomized, double-blind, placebo-controlled trial aims to evaluate ML-007C-MA for treating hallucinations and delusions in ADP patients, with a target enrollment of 300 participants. MapLight anticipates reporting topline results in the second half of 2027.

About ML-007C-MA

ML-007C-MA, also termed ML-007C/PAC, is an oral, extended-release, fixed-dose combination therapy. It incorporates the investigational M1/M4 muscarinic agonist ML-007, along with a peripherally acting anticholinergic (PAC). This combination is designed to activate both M1 and M4 muscarinic receptors in the central nervous system, potentially offering therapeutic benefits while mitigating peripheral cholinergic side effects. ML-007C-MA aspires to provide a well-tolerated treatment option with convenient dosing, capable of exceeding expected central nervous system exposures to improve symptoms.

Current Challenges in Alzheimer's Disease Psychosis

Alzheimer's Disease Psychosis (ADP) is a serious complication affecting approximately 40% of individuals diagnosed with Alzheimer’s Disease (AD). Characterized by hallucinations and delusions, ADP can lead to accelerated cognitive and functional decline, higher institutionalization rates, and increased mortality. This highlights the pressing need for effective therapeutic interventions.

About MapLight Therapeutics

MapLight Therapeutics is a clinical-stage biopharmaceutical company dedicated to enhancing the lives of patients suffering from central nervous system disorders. Founded by prominent leaders in psychiatry and neuroscience, the company's innovative discovery platform aims to develop circuit-specific pharmacotherapies, addressing gaps in current treatment options.

Learn More

For more detailed information about MapLight Therapeutics and its initiatives, visit www.maplightrx.com.

Forward-Looking Statements

This announcement may contain forward-looking statements, reflecting the company's expectations about potential benefits from current and future product candidates and clinical programs. Factors influencing these forward-looking statements include, but are not limited to, regulatory filings, clinical trial results, and funding availability. Specific risks and uncertainties are outlined in the company’s filings with the U.S. Securities and Exchange Commission.

Contact Information

For investor inquiries, reach out at investors@maplightrx.com. For media inquiries, contact media@maplightrx.com.