Neumora's NMRA-511 posts 0.34-effect size ahead of H2 2026 dose-finding data
A pre-specified analysis already showed effect sizes on agitation and aggression scores; the next readout tests whether higher doses in a MAD expansion cohort extend that signal.
Executive Summary
- Neumora has already disclosed a positive pre-specified analysis of its Phase 1b agitation trial, giving the pending readout a concrete baseline to build on rather than a first look at the drug.
- The next data covers a higher-dose expansion cohort designed to inform the dose Neumora carries into a Phase 2 study, making it a dose-selection readout rather than a fresh efficacy test.
- No trial in this indication shares NMRA-511's target or mechanism, leaving the asset without a direct mechanistic comparator even as several small-molecule and antibody programs pursue the same agitation endpoint through different biology.
- A dose-response signal that holds or improves at higher exposure would support the Phase 2 dose Neumora has already said it plans to select in the first quarter of 2027; a flat or worse safety trade would put that timeline at risk.
What's already disclosed
The trial behind this catalyst, NCT06546995, completed in November 2025 with 87 patients enrolled. Neumora already reported topline Phase 1b results in January 2026 and followed with a pre-specified analysis on March 30, 2026. In that pre-specified population of 53 patients with a Neuropsychiatric Inventory Agitation/Aggression score of 4 or higher, matching the enrollment criteria other sponsors use in their pivotal studies, NMRA-511 produced a Cohen's d effect size of 0.34 on the Cohen-Mansfield Agitation Inventory (CMAI) total score and 0.51 on the CMAI aggression sub-factor at Week 8. The company described tolerability and safety as consistent with the earlier topline analysis. NCT06546995+1Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's DiseaseNCT06546995Neumora Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides ...Mar 30, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What's next
The pending event is data from a multiple ascending dose (MAD) expansion cohort evaluating higher doses of NMRA-511, expected in the second half of 2026. Neumora has said it plans to initiate a Phase 2 study in Alzheimer's disease agitation in the first quarter of 2027. The trial's registered primary endpoints cover both safety and tolerability based on treatment-emergent adverse events and validated clinical scales, and the change from baseline to Week 8 on the CMAI total score. The pending cohort will test whether the effect already seen at lower doses extends, plateaus, or trades off against tolerability as dose increases, the fact that will most directly inform the Phase 2 dose. Neumora+1Neumora Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides ...Mar 30, 2026Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's DiseaseNCT06546995
Trial mechanics
The registry lists the trial's enrollment as reduced from 96 to 87 patients in a May 2026 update. That change sits within the routine band the operational model uses to flag enrollment shifts, which only registers moves at 20% or more; a 9% reduction on a completed Phase 1 trial is not a distress signal. The trial's primary completion date of November 19, 2025 has not changed since it was first set, and the amendment history shows one enrollment-count edit and one status change to Completed, a pattern the protocol-stability read labels Stable. NCT06546995Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's DiseaseNCT06546995
Competitive positioning
No competitor trial in Alzheimer's disease agitation shares NMRA-511's target or mechanism class. Bristol-Myers Squibb's KarXT and xanomeline programs are running Phase 3 trials in the same agitation endpoint through a muscarinic receptor mechanism, and AB Science's masitinib and Annovis Bio's buntanetap are pursuing the same indication through different targets. NMRA-511's isolation on mechanism means this readout has no same-target result to be measured against; the informative comparison is against the drug's own lower-dose data, not against a rival's benchmark.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.