Head-to-head evidence

LY03017 vs Roluperidone

Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.

Schizophrenia

Shared mechanism: Serotonin 5-HT2A receptor (antagonist / inverse agonist) · full Schizophrenia pipeline

LY03017

Developed by Luye Pharma Group

Phase 1 in Schizophreniasmall molecule
Partial signal

NCT06388551 · Phase 1 · status unknown

This early-phase study randomly assigned healthy volunteers to ascending single oral doses of LY03017 or matching placebo under quadruple-blind conditions, tracking adverse events as the primary outcome. No results have been posted, so it remains a well-designed, blinded, placebo-controlled trial whose findings are not yet known.

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Roluperidone

Developed by Minerva Neurosciences

Phase 3 in Schizophreniasmall molecule
Partial signal

NCT03397134 · Phase 3 · completed

This was a randomized, double-blind, placebo-controlled Phase 3 efficacy trial with an adequate sample (513 patients) and a hard clinical primary endpoint: change in the validated PANSS Marder negative symptom factor score (NSFS) at 12 weeks. However, the primary endpoint comparison was not met under the protocol's predefined multiplicity-adjusted threshold (64 mg vs placebo p=0.043 exceeded the required p≤0.025), and the 32 mg dose showed essentially no separation from placebo. Because the primary result was non-significant, the trial provides real but limited evidence despite its strong design.

Next expected readout: December 2027 · NCT07565428 (registry estimate)

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The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: LY03017's landscape · Roluperidone's landscape