ArticleCNS drugs2026
A Phase 1 Open-Label Study Assessing the Safety and Pharmacokinetics of TV-46000, an Extended-Release Injectable Suspension of Risperidone for Subcutaneous Use.
Article in CNS drugs, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTV-46000 (Uzedy
methodsIndividuals diagnosed with schizophrenia or schizoaffective disorder were assigned to 1 of 8 cohorts, which consisted of single escalating doses (50 to 225 mg) or 3 multiple doses (75 mg or 150 mg) administered every month for 3 months. Every cohort was preceded by a run-in period of 7 days with daily oral risperidone (2-6 mg) followed by a 7-day washout period before the TV-46000 injection. TV-46000 was administered in the abdomen in all but one cohort, where 225 mg was administered in the upper arm, to assess interchangeability between injection sites. Outcome measures reported were adverse events (AEs), local tolerability, changes in neurological and clinical assessments, and PK measures (determined by risperidone and 9-OH risperidone total active moiety [TAM] concentrations).
resultsOf the 194 participants screened, 99 were included in the study. Of the 99 participants, 13 discontinued the study, but none of the discontinuations were related to the treatment. Most participants were Black or African American men, with a mean age of 44.2 years and a mean body mass index of 28.53 kg/m
conclusionsOverall, TV-46000 was well tolerated with no new safety signals detected compared with other formulations of risperidone. The PK profile of TV-46000 exhibited favorable characteristics of an extended-release formulation, including rapid initial release for fast onset of action and prolonged systemic exposure adequate for monthly administration.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.