MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer’s Disease Psychosis
January 5, 2026 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Alzheimer's Disease, FDA, MapLight Therapeutics, biopharma, central nervous system diseases, clinical trials, fast track designation, neurodegenerative disease
5 January 2026 — California and Massachusetts, US — MapLight Therapeutics, Inc today 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).
The Fast Track process is intended to facilitate the development and expedite the review of investigational therapies for serious conditions with unmet medical need. A drug with Fast Track designation may be eligible for more frequent interactions with the FDA, as well as accelerated approval and priority review, if applicable criteria are met.
“FDA’s Fast Track designation underscores the significant unmet need of the millions of people with Alzheimer’s disease psychosis with no currently approved treatment options,” said Erin Foff, M.D., Ph.D., Chief Medical Officer of MapLight. “This designation is an important milestone for the ML-007C-MA program that recognizes its potential to address the psychotic symptoms that frequently accompany the cognitive decline in people living with Alzheimer’s disease. We remain committed to working closely with the FDA to advance this program expeditiously through our ongoing Phase 2 VISTA study.”
In a Phase 1 clinical trial, ML-007C-MA demonstrated a generally favorable safety and tolerability profile with twice daily dosing in healthy elderly participants. Enrollment is currently ongoing in the Phase 2 VISTA study, a randomized, double-blind, placebo-controlled trial evaluating ML-007C-MA for the treatment of hallucinations and delusions associated with ADP. MapLight expects to enroll 300 participants in the trial and report topline results in the second half of 2027.
About ML-007C-MA
ML-007C-MA, also referred to as ML-007C/PAC, is an oral, extended-release, fixed-dose combination of the investigational M1/M4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic (PAC). ML-007C-MA is designed to activate both M1 and M4 muscarinic receptors in the central nervous system to drive efficacy, while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects. ML-007C-MA offers the potential to be a well-tolerated treatment option with convenient dosing, while achieving or exceeding CSF exposures expected to result in improvement across key symptom domains.
About MapLight Therapeutics
MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. The company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients. The company’s discovery platform holds the potential to fill this void by identifying neural circuits causally linked to disease and targeting those circuits for therapeutic modulation. For more information, please visit www.maplightrx.com.
