Data Readout

MapLight's ZEPHYR schizophrenia trial completes, results due by mid-August

The Phase 2 test of ML-007C-MA finished enrollment at 307 patients and closed out on schedule, setting up a PANSS readout against placebo within weeks.

By AppliedXLJuly 14, 2026Trial NCT07038876

Executive Summary

MapLight Therapeutics finished its placebo-controlled Phase 2 test of ML-007C-MA in hospitalized schizophrenia patients on schedule, and topline results are due within weeks.
The trial closed at its enrollment target with a clean status progression from recruiting to completed, showing no signs of the operational strain that sometimes accompanies late-stage schizophrenia trials.
The readout will test whether ML-007C-MA separates from placebo on the PANSS total score, the endpoint regulators and investigators use to judge antipsychotic efficacy in acute psychosis.
ML-007C-MA enters a schizophrenia pipeline dominated by dopamine, muscarinic, and serotonergic mechanisms, with no disclosed target of its own to place it directly against any single rival.
MapLight is running the same drug in a second, longer open-label study, so this readout also shapes how that follow-on program is read.

The trial

ZEPHYR is a randomized, double-blind, placebo-controlled Phase 2 trial that assigned 307 hospitalized adults with an acute exacerbation of schizophrenia 1:1:1 to placebo, ML-007C-MA 210/3 mg twice daily, or ML-007C-MA 330/6 mg once daily. The trial's registry status moved from Recruiting to Active-not-recruiting on May 18, 2026, then to Completed on July 9, 2026. Enrollment landed at 307 against a 300-patient prior count, a 2.3% increase that the trial's own operational baseline classifies as within the routine range, not a deviation. The primary completion date moved from January 2027 to August 2026 during the trial's conduct, and the study finished ahead of that revised date, reaching primary completion on June 4, 2026. NCT07038876+1

Probability of Success

Endpoint Met34%

Completes95%

Clinical Significance20%

Regulatory65%

The endpoint bar

The primary endpoint is the change from baseline to end of treatment, defined as Week 5, in the Positive and Negative Syndrome Scale (PANSS) total score, a 30-item clinician-rated measure of psychotic symptom severity, against placebo. Key secondary endpoints track the Clinical Global Impression-Severity (CGI-S) score and the PANSS-Marder positive and negative factor scores over the same five-week window. Chief Executive Officer Chris Kroeger said at enrollment completion that "the enrollment in the ZEPHYR trial reflects the critical unmet need for new treatment options in schizophrenia". The trial's inpatient, acute-exacerbation population and five-week endpoint window are consistent with standard antipsychotic registration-track designs, though this study is not registrational. NCT07038876+1

Timing discipline

MapLight's guidance on when results would post moved several times over the trial's life, from a second-half-2026 window disclosed in December 2025 to a Q3 2026 estimate in January and March 2026, and then twice to the same mid-August 2026 month in May and June 2026. The two most recent disclosures agree on the same August 1 to August 31, 2026 window, indicating the sponsor's near-term guidance has held steady even as earlier, broader windows were narrowed. The trial's primary completion landed on June 4, 2026, roughly two months ahead of the guided readout window, consistent with the usual lag between last-patient completion and a topline data announcement. NCT07038876+1

The competitive field

Schizophrenia's active Phase 2 and Phase 3 field includes muscarinic-receptor agonists such as KarXT from Bristol-Myers Squibb, dopamine D2/D3-targeted agents such as cariprazine and lumateperone, and Neurocrine Biosciences' NBI-1117568, none of which share a disclosed target or mechanism class with ML-007C-MA. ML-007C-MA's own target and mechanism are not classified in available competitive data, which means the comparison rests on indication and phase rather than mechanism. MapLight is separately running a long-term, open-label Phase 2 extension of ML-007C-MA (NCT07459647) in the same indication, positioning the ZEPHYR result as the first controlled readout the company has generated for this drug in schizophrenia. NCT07038876

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