MapLight's Phase 2 ZEPHYR schizophrenia trial meets primary endpoint at one dose
MapLight Therapeutics reported topline results from ZEPHYR, a Phase 2 trial of ML-007C-MA in hospitalized adults with schizophrenia experiencing an acute exacerbation of psychosis, on July 27, 2026. The 210/3 mg twice-daily dose met the primary endpoint, reducing PANSS total score by 4.5 points more than placebo at Week 5, while the 330/6 mg once-daily arm did not reach statistical significance. The company plans to discuss next steps with the FDA at an end-of-phase 2 meeting before a further pivotal trial.
Key points
- 210/3 mg BID arm: PANSS total score down 4.5 points versus placebo at Week 5 (p=0.015), meeting the primary endpoint
- 330/6 mg QD arm: 2.8 points versus placebo, p=0.110, not statistically significant
- Prespecified cognitive composite score improved in the baseline-impaired subgroup (effect size 0.51, p=0.041)
- Company plans to engage the FDA at an end-of-phase 2 meeting and identify sites for an additional pivotal trial
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on July 27, 2026.
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