Asset profile
Roluperidone
Small molecule
Evidence outlook · lead readout
NCT03397134 · Negative Symptoms of Schizophrenia
The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found. A further registrational readout is expected around 2027-12.
NCT03397134: 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.
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
67 competitors in this universe: 1 direct rival (same mechanism and indication), 6 same-class, 60 same-indication; 38 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Roluperidone: this drug | Phase 3 | Small molecule | Serotonin 5-HT2A receptor (antagonist / inverse agonist), Sigma-2 receptor complex | ||
| LY03017 | Phase 1 | Small molecule | Serotonin 5-HT2A receptor (antagonist / inverse agonist), 5-HT2A/5-HT2C, 5-HT2A/2C receptor | ||
| Pimavanserin (Nuplazid) | Approved | Small molecule | 5-HT2A/2C receptor, Serotonin 5-HT2A receptor (antagonist / inverse agonist) | ||
| ACP-204 | Phase 3 | Small molecule | Serotonin 5-HT2A receptor (antagonist / inverse agonist) | ||
| Anplag Tab | Phase 3 | Small molecule | Serotonin 5-HT2A receptor (antagonist / inverse agonist) | ||
| Sarpogrelate (Anplag) | Phase 3 | Small molecule | Serotonin 5-HT2A receptor (antagonist / inverse agonist) | ||
| Deramciclane | Phase 2/3 | Small molecule | Serotonin 5-HT2A receptor (antagonist / inverse agonist) | ||
| Zervimesine | Phase 2 | Small molecule | Sigma-2 receptor complex | ||
| Aripiprazole (Abilify Maintena) | Approved | Small molecule | Dopamine D2 and serotonin 5-HT1A receptors (partial agonist), Dopamine D2/D3 and serotonin 5-HT1A receptor, Dopamine D2 receptor (partial agonist) | ||
| Aripiprazole (Abilify MyCite) | Approved | Combination | Dopamine D2 and serotonin 5-HT1A receptors (partial agonist); serotonin 5-HT2A receptor (antagonist) | ||
| Aripiprazole (Abilify) | Approved | Small molecule | Dopamine D2/D3 and serotonin 5-HT1A receptor | ||
| Aripiprazole Lauroxil (Aristada Initio) | Approved | Small molecule | Dopamine D2/D3 and serotonin 5-HT1A receptor | ||
| Aripiprazole Lauroxil (Aristada) | Approved | Small molecule | Dopamine D2/D3 and serotonin 5-HT1A receptor | ||
| Asenapine | Approved | Small molecule | Dopamine D2 and serotonin 5-HT2A receptors (antagonist) | ||
| Brexpiprazole (Rexulti) | Approved | Small molecule | Dopamine D2/D3 and serotonin 5-HT1A receptor | ||
| Cariprazine (Vraylar) | Approved | Small molecule | Dopamine D3/D2 receptor (partial agonist) |
…and 52 more. Research shows the complete landscape.
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Upcoming events
(1 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2027 (1)
December 2027 (1)
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.